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PubMed1991

Phase II study of 4'-deoxydoxorubicin (esorubicin) in advanced or metastatic adenocarcinoma of the stomach.

4'-deoxydoxorubicin (DxDx) was administered to 17 patients with locally advanced or metastatic gastric adenocarcinoma. Treatment cycles were repeated every 21 days. 15 eligible patients with a Karnofsky performance status of 50% or better (median: 70%) received at least one course of treatment; a median of 2 courses of DxDx was delivered (range 1 to 13). The median dose per treatment course was 26 mg/m2 (range 8.5 mg/m2 to 53 mg/m2). 69% of patients required dose reduction following the first course of therapy due to grade 3 or 4 myelosuppression, primarily neutropenia. The principal side effects included anemia, mild gastrointestinal toxicities, and alopecia; one patient experienced a 10% decrease in cardiac ejection fraction without clinical cardiac toxicity. Of the 15 patients assessable for response and toxicities, 1 patient had a partial response lasting 2.5 months. The median survival from the time of the first treatment was 3.3 months. We conclude that DxDx has only limited activity in the treatment of advanced gastric adenocarcinoma.

Adenocarcinoma↗
PubMed1986

Phase I clinical and pharmacokinetic study of cyclophosphamide administered by five-day continuous intravenous infusion.

A total of 14 patients, 7 male and 7 female, received in all 21 evaluable courses of cyclophosphamide administered by 5-day continuous infusion. Cyclophosphamide doses were escalated from 300 to 400 mg/m2 per day for 5 days and repeated every 21-28 days. The patient population had a median age of 55 years (range 38-76) and a median Karnofsky performance status of 80 (range 60-100). Only 1 patient had not received prior therapy; 5 patients had received only prior chemotherapy, 1 had received only prior radiotherapy, and 7 had received both. Tumor types were gastric (1), lung (2), colon (4), urethral adenocarcinoma (1), cervical (2), chondrosarcoma (1), melanoma (1), uterine leiomyosarcoma (1), and pancreatic (1). The dose-limiting toxicity was granulocytopenia, with median WBC nadir of 1700/microliter (range 100-4800) in 8 heavily pretreated patients treated at 350 mg/m2 per day for 5 days. One patient without heavy prior treatment received two courses at 400 mg/m2 and had WBC nadirs of 800/microliter and 600/microliter. WBC nadirs occurred between days 9 and 21 (median 14). Drug-induced thrombocytopenia occurred in only one patient (350 mg/m2 per day, nadir 85,000/microliter). Neither hyponatremia nor symptomatic hypo-osmolality was observed. Radiation-induced hemorrhagic cystitis may have been worsened in one patient. Nausea and vomiting were mild. Objective remissions were not observed. The maximum tolerated dose for previously treated patients is 350 mg/m2 per day for 5 days. This dose approximates the doses of cyclophosphamide commonly used with bolus administration. Plasma steady-state concentrations (Css) of cyclophosphamide, measured by gas liquid chromatography, were 2.09-6.79 micrograms/ml. Steady state was achieved in 14.5 +/- 5.9 h (mean +/- SD). After the infusion, cyclophosphamide disappeared from plasma monoexponentially, with a t 1/2 of 5.3 +/- 3.6 h. The area under the curve of plasma cyclophosphamide concentrations versus time (AUC) was 543 +/- 150 micrograms/ml h and reflected a cyclophosphamide total-body clearance (CLTB) of 103 +/- 31.6 ml/min. Plasma alkylating activity, assessed by p-nitrobenzyl-pyridine, remained steady at 1.6-4.3 micrograms/ml nor-nitrogen mustard equivalents. Urinary excretion of cyclophosphamide and alkylating activity accounted for 9.3% +/- 7.6% and 15.1% +/- 2.0% of the administered daily dose, respectively. The t1/2 and AUC of cyclophosphamide associated with the 5-day continuous infusion schedule are similar to those reported after administration of cyclophosphamide 1500 mg/m2 as an i.v. bolus.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1985

Phase I clinical trial of fludarabine phosphate (F-ara-AMP).

F-Ara-AMP (fludarabine phosphate) is an adenosine analogue that is resistant to deamination; it is a more potent cytotoxic compound than ara-A in experimental tumor systems. F-Ara-AMP was given by continuous IV infusion over 5 days once every 4 weeks to 27 evaluable adult patients with advanced cancer. The median Karnofsky performance status was 70% (range 50%-90%), and the median age was 58 years (range 41-74). In addition to adequate blood counts, a creatinine clearance of at least 60 ml/min was required. The initial dose level was 35 mg/m2/day. Dose-limiting myelosuppression was seen in the first patient. Subsequent patients were treated at lower doses. Myelosuppression was the only major toxicity. Leukopenia was generally more prominent than thrombocytopenia, but 2 patients experienced prolonged thrombocytopenia which prevented further therapy. Nausea was minimal, and neither renal nor neurologic toxicity was encountered. In patients with good renal function a dose of 25 mg/m2/day can be safely administered. However, because of apparent cumulative myelosuppressive effects a lower dose is more appropriate for patients who have had extensive prior chemotherapy or radiotherapy.

Adult↗
PubMed1987

Percutaneous endoscopic duodenostomy (PED). Case report.

Surgeons are increasingly using endoscopy to place transabdominal feeding tubes for enteral nutrition or gastric decompression. A possible extension for the application of this new technique is the direct placement of the feeding tube into the duodenal bulb. Two patients are presented in whom percutaneous endoscopic duodenostomy was successfully performed, although percutaneous endoscopic gastrostomy was not possible. It shows that this new method is technically possible. In both patients the positive influence of this technique on the patient's quality of life could be shown using the Spitzer Quality of Life Index and the Karnofsky Performance Status. Enteral nutrition was maintained for more than 6 weeks.

Aged↗
PubMed1983

Phase-II clinical trial of 4'-epi-doxorubicin in metastatic solid tumors.

4'-Epi-doxorubicin, one of the analogs of doxorubicin, was shown in experimental animal tumor models to have a wide spectrum of antitumor activity. In comparison, its toxic side effects were less prominent than those of doxorubicin. Results of the first phase-I and II clinical trials in human tumors have confirmed experimental data. The aim of our study was to carry out a broad phase-II clinical trial mainly in various types of primarily chemoresistant solid tumors to obtain further information on the antitumor activity spectrum and toxicity of 4'-epi-doxorubicin. Ninety-two patients, 55 males and 37 females aged from 32 to 75 with an average age of 51 years, were available for the study. Karnofsky performance status was not less than 50. Previous chemotherapy was recorded in 33 patients. The drug was administered at doses of 40 mg/m2 i.v. daily for 2 days in the first 25 patients and, in all other patients, the dosage was increased to 50 mg/m2 i.v. daily for 2 days (100 mg/m2/cycle). The overall response was registered in 18 (seven complete, 11 partial remissions) out of 92 patients (20%). Regarding tumor types, the response was observed in 2/15 lung, 4/15 stomach, 3/14 colorectal, and 5/13 breast cancers. No response was observed in 11 patients with melanoma and five with hypernephroma. Toxicity was mild (myelosuppression, gastrointestinal toxicity, cardiotoxicity) and tolerable for the patients. On the basis of these results, we could conclude that 4'-epi-doxorubicin is an active antitumorigenic agent in breast cancer and in stomach, rectal, and small-cell lung tumors. These results justify further clinical investigation of this compound especially in combination chemotherapy treatment.

Adult↗
PubMed1996

Health-related quality of life of HIV-infected women: evidence for the reliability, validity and responsiveness of the Medical Outcomes Study Short-Form 20.

The purpose of this study was to assess the reliability, validity and responsiveness of a health-related quality of life (HRQOL) instrument, the Medical Outcomes Short-Form 20-Item General Health Survey (MOS SF-20), in a sample of women with the human immunodeficiency virus (HIV). Longitudinal data were collected on 202 HIV-infected women without AIDS who were receiving care at Kings County Hospital or SUNY Health Sciences Center, Brooklyn, New York. Internal consistency results showed acceptable reliability for the four multi-item MOS scales (role function, physical function, general health perceptions and mental health). Symptomatic patients and patients with lower Karnofsky Performance Status (KPS) ratings reported lower HRQOL than those who were asymptomatic or who had higher KPS scores. Patients who were older, unemployed or who had a history of injection drug use (IDU) also reported lower HRQOL than those who were younger, employed or who had no drug use history. Adjusted mean scores on the MOS role and physical functioning scales proved sensitive to differences in clinical status over time. The MOS SF-20 is a reliable and valid instrument of HRQOL for women with HIV infection. Its sensitivity to differences in clinical status over time suggest that it may be useful as an HRQOL indicator for HIV/AIDS clinical trials.

Adult↗
PubMed1989

Hepatic irradiation in primary and metastatic liver cancer.

Between December 1973 and September 1987, 21 patients with primary liver cancer and 41 patients with metastatic liver cancer were treated with external irradiation, intra-arterial infusion chemotherapy and/or transarterial embolization (TAE) at the National Medical Center Hospital, the National South Kyushu Central Hospital and the National Kure Hospital. Of the patients with primary liver cancer, 13 cases were treated with intra-arterial infusion chemotherapy (30-40 mg adriamycin or 10 mg mitomycin C) and hepatic irradiation. Eight cases were treated by TAE and hepatic irradiation. In the Child A group, the survival period of the chemotherapy + hepatic irradiation cases (mean: 608 days) was longer than that of the TAE + hepatic irradiation cases (mean: 216 days). The median survival period of all the cases was 7.0 months (mean: 10.9 months). For 16 of the 21 patients (who had absorbed over 40 Gy), the median survival period was 11.9 months (mean: 11.7 months). For 5 of the 21 patients (who had absorbed below 40 Gy), the median survival period was 4.3 months (mean: 7.9 months). Of the patients with metastatic liver cancer, the median survival period was 7.2 months (mean: 8.0 months). For 22 of the 41 patients (who had absorbed over 40 Gy), the median survival was 7.9 months (mean: 12.6 months). For 19 of the 41 patients (who had absorbed below 40 Gy), the median survival period was 1.7 months (mean: 2.6 months). The pretreatment serum GOT (glutamate oxaloacetate transaminase) levels and the pretreatment Karnofsky performance status index were the factors governing the prognosis of the cases with metastatic liver cancer, while toxicity was generally mild.

Aged↗
PubMed1990

Ifosfamide/etoposide and mesna uroprotection in advanced breast cancer.

The object of the study was to evaluate the effectiveness of ifosfamide/etoposide and mesna therapy in advanced breast cancer. A total of 44 patients with breast cancer were included in the trial. Eligibility criteria included measurable, refractory disease; prior anthracycline therapy (or its contraindication); a life expectancy of at least 3 months; and adequate hepatic, renal, CNS and bone marrow function. All patients were less than or equal to 70 years of age and had a Karnofsky performance status of greater than or equal to 50%. There were 36 evaluable cases. Sites of metastatic disease included bone (19), skin (18), liver (9), lung (14), lymph node (19), and miscellaneous (7). Treatment consisted of 1,500 mg/m2 ifosfamide given i.v. on days 1-5, 120 mg/m2 etoposide given i.v. on days 1-3, and 400 mg i.v. mesna given with and at 4 and 8 h after ifosfamide. Cycles were repeated every 28 days. Initial doses were reduced by 25% or 50% in patients who had previously undergone both chemotherapy and radiotherapy. A median of 4 cycles (range, 2-8) were given. The myelotoxicity was marked: WHO grades 3/4 leukopenia (n = 37), grades 3/4 thrombocytopenia (n = 12), and grades 2/3 anemia (n = 13). Due to myelotoxicity, dose reduction or prolongation of treatment-free intervals was necessary in 28 cases. Alopecia was seen in 35 patients and CNS toxicity, in 8. Partial remission (PR) was obtained in five cases and complete remission (CR), in three. Sites of response included the lung (5), skin (4), lymph node (5), and peritoneum (1). The duration of response was 4 (n = 2) and 8 (n = 1) months for CR and 2 (n = 2), 6 (n = 2), and 10 (n = 1) months for PR. We conclude that the ifosfamide/etoposide and mesna regimen is effective, but its myelotoxicity is treatment-limiting.

Adult↗
PubMed1994

Phase I study of high-dose cisplatin, ifosfamide, and etoposide.

To test the feasibility of a regimen of high-dose cisplatin, ifosfamide, and etoposide (VP-16; VIPP regimen), we registered 15 patients with advanced non-small-cell lung cancer in a phase I trial of the Northern California Oncology Group. One cycle of treatment consisted of high-dose cisplatin given at 100 mg/m2 i.v. on days 1 and 8, VP-16 given at 60-75 mg/m2 i.v. on days 1-3, plus ifosfamide given at 1.0-1.2 g/m2 i.v. on days 1-3; cycles were repeated every 28 days. There were 13 men and 2 women; the median age was 59 years (range, 47-72 years). The median Karnofsky performance status (KPS) was 90 (range, 70-100). All patients were assessable for toxicity and response. The median number of cycles delivered per patient was two (range, one to four). Hematologic toxicity was dose-limiting and required de-escalation of the ifosfamide and VP-16 doses. Ten patients developed a white blood count of < 1000/mm3 and seven patients developed a platelet count of < 50,000/mm3. The duration of cytopenia increased progressively with each subsequent cycle of therapy. Two patients required antibiotics for neutropenic fever with documented infections (pneumonia, bacteremia). Seven patients received red blood cell transfusions for a hemoglobin level of < 8 gm/dl. Grade III or IV non-hematologic toxicities were uncommon and involved one patient each with grade 3 ototoxicity and grade 3 neurotoxicity. Five patients developed laboratory evidence of renal salt wasting. The overall response rate was 33% (5/15) with a complete response being achieved by two patients (13%) and a partial response being attained by three (20%). The overall median survival was 44 weeks. We conclude that although this regimen demonstrated activity, hematologic toxicity limited its use in the palliative treatment of non-small-cell lung cancer. Using hemopoietic growth-factor support to permit dose escalation, this schedule of VIPP may be of interest in a number of different chemotherapy-sensitive tumor types.

Aged↗
PubMed1991

Cancer chemotherapy in the elderly: a series of 51 patients aged greater than 70 years.

A total of 2,238 new cancer patients were treated in our institution in 1988; among the 423 (18.9%) who were greater than 70 years old, 51 underwent chemotherapy. The median age was 75.8 years, and the Karnofsky performance status (KPS) was greater than or equal to 70% for 40 patients. Malignancies were hematopoietic in 24 cases (47%) and digestive in 15 patients (29%), and 12 subjects (24%) had other types of cancers. The first chemotherapy course was given at the full dose to 23/51 (45.1%) patients. The drug dose was reduced for 28/51 (54.9%) patients, due in 25 cases to the subjects being greater than 70 years old. Neither age, KPS, pretreatment assessment, nor cancer extent was correlated with the modifications made to the first cycle. An overall toxicity of grade 3 + 4 (WHO grading scale) was noted in 10 subjects (19.6%). Although these elderly patients were probably selected, analysis of their charts did not evidence an increase in chemotherapy toxicity, regardless of the dose they received.

Aged↗
PubMed1992

Assessing the needs and quality of life of patients with HIV infection: development of the HIV Overview of Problems-Evaluation System (HOPES).

OBJECTIVE: To develop and evaluate the psychometric properties (reliability, validity etc.) of a comprehensive Quality of Life (QOL) tool, for patients infected with the human immunodeficiency virus (HIV), that was adapted from a previously validated cancer tool. DESIGN: Cross-sectional, patient completed written surveys and interviews. SETTING: The Medical Centers serving HIV infected patients in the Los Angeles community including UCLA, community physicians, Veterans Affairs Medical Centers, and a County hospital: and additional data contributed from Johns Hopkins University Medical Center CMV Retinitis Clinic. PATIENTS: Patients (n = 318) with HIV infection including asymptomatic (37%), ARC (20%), AIDS (25%) and AIDS with Cancer (18%) receiving health services at one of the above sites. MEASUREMENTS: The patients self-administered the newly developed instrument, the HOPES (HIV Overview of Problems-Evaluation System), other QOL related tools including the Medical Outcomes Study instrument adapted for HIV (MOS-HIV) the Profile of Mood States (POMS), the Perceived Adjustment to Chronic Illness Scale (PACIS), and the Physical Activity Scale (PAS). Brief interview to assess the Karnofsky Performance Status Score (KPS). Measured sociodemographic characteristics included age, sex, race, HIV risk factor, education etc. Assessed medical history, current medications, HIV clinical classification. MAIN RESULTS: The sociodemographic and medical characteristics of the sample resemble those of the general population with HIV infection in this geographic area: 96% male, 28% nonwhite, 84% homosexual contact as risk factor, 75% receiving antiretroviral therapy. The adaptation of the cancer QOL instrument to HIV appears to have face and content validity according to patients and health professionals who care for HIV infected patients. Analyses of the psychometric properties found that the HOPES has a similar structure to its parent instrument following factor analyses which results in five summary scales representing the Physical, Psychosocial, Medical Interaction, Sexual and Significant Other/Partners domains in addition to a Global Score. Internal consistency of 35 subscales is high with a mean alpha coefficient of 0.82. Correlations of the HOPES summary scales with other QOL instruments are in the predicted directions. Comparing patients within the HIV clinical diagnostic categories on the HOPES Global, Physical, and Psychosocial Summary Scales indicates that Asymptomatic Patients have better QOL than symptomatic patients. This finding is also found in the other QOL instruments which provides evidence of construct validity. CONCLUSIONS: The HOPES is an excellent tool for identifying the problems and needs of patients with HIV infection and for assessing their quality of life. It is reliable, valid and acceptable to patients. The tool may be especially useful in developing a normative data base.

Acquired Immunodeficiency Syndrome↗
PubMed1992

A phase II trial of interferon alpha-2A plus fluorouracil in advanced renal cell carcinoma. A Hoosier Oncology Group study.

In vitro studies have documented the synergistic activity of interferon (IFN) and fluorouracil (5-FU) in human cancer cell lines, and recent clinical trials have demonstrated the efficacy of this combination in metastatic colon cancer. The current study was undertaken to evaluate the combination of IFN alpha-2a plus 5-FU in previously untreated patients with metastatic renal cell carcinoma. From May 1990 through August 1990, 14 patients with metastatic renal cell carcinoma were treated with 5-FU 750 mg/m2/day continuous infusion IV days 1-5, followed by weekly IV infusions of 5-FU 750 mg/m2 beginning on day 12. Patients concurrently received IFN alpha-2a 9 x 10(6) IU subcutaneously 3 times per week beginning on day 1. The median age of patients treated was 57 (range 38-80) with a median Karnofsky performance status of 90 (range 60-100). Sites of metastases included lung only in 6 patients, liver only in 1 patient, 1 patient had bilateral disease at presentation, and the remaining patients had multiple sites of metastases. The median duration of therapy was 2 months. The predominant toxicities seen were stomatitis, nausea, flu-like symptoms and neurotoxicity. The only grade IV toxicity observed was severe vomiting in 1 patient, though 5 patients discontinued therapy within 2 months because of poor subjective response. With a minimum follow-up of 13 months no objective responses were seen. Thirteen of the 14 patients have had progressive disease and 11 have died. The median time to progression was 2 months (range 0.5-6 months) and the median survival was 5 months (range 2-14.5 + months).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

Survival following interstitial brachytherapy for recurrent malignant glioma.

The treatment of recurrent malignant glioma is difficult and at present largely disappointing. Furthermore the results of any treatment modality need to be interpreted with knowledge regarding patient selection and timing of treatment. The results of interstitial brachytherapy using iodine-125 in 23 patients are presented. There were no operative complications. Median survival time from tumour recurrence and implantation was 36 and 25 weeks respectively. Karnofsky Performance Status (KPS) was significantly associated with survival, though patient age, original tumour histology, prior chemotherapy, and time to recurrence were not. Treatment does confer modest survival benefit as compared to controls, but our results are not as impressive as others. Reasons for this finding are discussed.

Adult↗
PubMed1994

Fourth ventricle ependymomas. A study of 20 cases with survival analysis.

Twenty patients with fourth ventricle ependymoma were treated surgically at our Neurosurgery Division between January 1976 and December 1990. Ependymoblastomas and mixed gliomas operated on in the same period have not been considered. A statistical analysis of our cases and a review of the largest published series show that favourable prognostic factors are: age over 16, post-operative radiotherapy to the posterior cranial fossa and a good Karnofsky performance status (KPS) after operation. The 5-year survival rate of patients under 16 was 20%, in comparison with 60% of adults (p = 0.013). Post-operative radiotherapy to the posterior cranial fossa improved the survival markedly (5-year survival rate 68%, versus 18% without treatment; p = 0.011). The differences of survival are also significant according to a multivariate analysis (p = 0.038). Patients with a post-operative KPS over 70 had a 5-year survival rate of 61% as against 17% of the group with a worse clinical condition (p = 0.032); the multivariate analysis confirmed also that this difference was significant (p = 0.046). Pre-operative symptoms and signs, and KPS, histological grade and extent of surgical removal seem to influence the prognosis, even if the differences of survival are not statistically significant. The statistical relevance of postoperative residual tumour on CT or MRI was brought out on multivariate analysis (p = 0.044).

Adolescent↗
PubMed1994

Interstitial brachytherapy for low-grade cerebral gliomas: analysis of results in a series of 36 cases.

The results obtained with interstitial brachytherapy in thirty-six low-grade cerebral gliomas (2 pilocytic astrocytomas, 23 astrocytomas and 11 oligodendrogliomas) are reported (mean follow-up: 75 months, range 37-159). All tumours were situated in locations which did not call for surgical removal as the treatment of choice. Their volume ranged from 4 to 82 cc (m = 32); the Karnofsky performance status (KPS) of the treated patients lay between 0.60 and 0.90. The sources utilized (Iridium-192 in 32 cases and Iodine-125 in 4) were implanted permanently in 22 patients and temporarily in 14, using the Talairach stereotactic apparatus. The mean peripheral dose was 89.7 Gy for the permanent implants and and 42.8 Gy with a rate of 32.05 cGy/h for the temporary implants. External beam irradiation was added for tumour volumes greater than 35 cc (19 cases) on a second target volume extending 2 cm beyond the tumoural borders treated with interstitial irradiation. The survival estimates for the entire group showed a probability of 82.9% at 60 months, of 56.8% at 96, 39.4% at 120 (m.s.t.: 112 months). The quality of life in the treated patients was satisfactory, KPS never falling below a mean score of 0.70. The extent of the target volume turned out to be the most significant factor influencing survival at the multivariate analysis. Severe neurological impairment due to radionecrosis occurred in 4 patients (11%), three of them requiring surgical decompression.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1990

Phase I/II study of recombinant interferon alpha and gamma in advanced progressive renal-cell carcinoma.

In vitro studies have documented the synergistic antiviral and antiproliferative activity of recombinant interferon alpha (rIFN alpha) and rIFN gamma. Furthermore, rIFN gamma is a strong immunomodulator with optimal effects at a relative low dose (0.1 mg/m2). On the basis of these observations, we began a phase I/II study with the combination of rIFN gamma at 100 micrograms/m2 (2 x 10(6) IU/m2) and rIFN alpha 2c 6 micrograms/m2 (2 x 10(6) IU/m2), injected twice a week subcutaneously. In cases of stable or progressive disease we increased the dose of rIFN alpha 2c every 2 weeks by 6 micrograms/m2 until the maximum tolerated dose was reached. A total of 32 patients with proven progressive renal-cell carcinoma were included. Of the 31 eligible patients, 21 were male and 10 female, their average age was 57.2 years (range 35-72), 28 had had nephrectomy, their median Karnofsky performance status was 90% (70%-100%), and their tumors were localized predominantly to visceral tissue. In 2, response was complete and in 6 it was partial, for a response rate of 25%. The disease had stabilized in 5 patients and progressed in 16. The median duration of partial response was 14 months (8-16 months); of 2 cases of complete response, 1 persists (23+ months), and the other suffered a relapse after 22 months. The median time to response was 24 weeks (18-24 weeks). The maximum tolerated dose of rIFN alpha was 30 micrograms/m2 (range of 6-36 micrograms/m2). Side-effects included those known to be associated with interferon treatment. One patient developed septicemia during a period with grade 4 leukopenia. Our study permits no conclusion regarding the additional value of rIFN gamma.

Adult↗
PubMed1992

Phase I trial of ImuVert (natural membrane vesicles associated with ribosomes) in patients with advanced cancer.

ImuVert, a new biological response modifier, was evaluated for toxicity and potential efficacy in patients with advanced cancer. This agent consists of sized, labile, natural membrane vesicles associated with ribosomes derived from Serratia marcescens. ImuVert induces enhanced in vitro macrophage and natural-killer-cell-mediated cytotoxicity, and has demonstrated antitumor activity in palpable animal tumor systems. A group of 39 patients with a variety of tumors, 25 men, 14 women, with a mean performance status (Karnofsky) of 80% and median age of 57 years were entered into this trial. ImuVert was administered subcutaneously weekly for a minimum of 3 weeks. A total of 183 treatments were evaluated. Flu-like systemic toxicities, including fever, chills, nausea, vomiting, diarrhea and hypotension were observed. Erythema, induration and tenderness developed at the injection sites. Myelosuppression, thrombocytopenia, anaphylaxis, rental and hepatic toxicities did not occur. All symptoms resolved within 24 h. Two patients with nodular lymphoma achieved a partial response and two minor responses were seen in patients with glioblastoma and melanoma. On the basis of ImuVert's biological activity, and tolerable toxicity it warrants further clinical investigation.

Adult↗
PubMed1994

CT-guided computer-assisted stereotactic resection of brain tumours.

A computer-assisted technique was developed for CT-guided stereotactic microsurgical resection of small intracerebral lesions. An original stereotactic retractor was developed to work with the Riechert-Mundinger's equipment for precise localisation, safe exposure and microsurgical removal of these tumours. A software-program was developed to work on an ordinary IBM-compatible PC/AT. It assisted the procedure from treatment planning till the end, including tumour excision, and provided computerized support for the removal of pathological tissues within the CT-defined boundaries of the lesion. 6 patients, harbouring supratentorial intracerebral lesions underwent surgery using this technique. 2 of them suffered from brain metastases, in 1 patient a cavernous angioma was removed, 2 patients had glial tumours, and in the last patient only radiation necrotic tissue was found to be the cause of ring-enhanced lesion, which had been suspected to be a recurrent glioma. Their largest dimensions varied between 18 and 30 mm and the age of the patients ranged from 15 to 52 years. In 2 cases the lesions were localised deeply in the region of basal ganglia and thalamus. In the remaining patients the tumours were rather superficial, infiltrating subcortical white-matter close to the central sulci. There was no mortality nor significant morbidity following the procedure, the Karnofsky Performance Status (KPS) cumulative scores being either unchanged (in 3), or improved (in 3 patients). Current state and modern concepts in image-guided open stereotactic methodology is discussed.

Adolescent↗