Biomedical subjects

J McClean

Publications and source records attributed to J McClean.

10 recordsLinked to original sources

PubMed2005

A phase II trial of olanzapine for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier Oncology Group study.

In a previous phase I study, olanzapine was demonstrated to be a safe and effective agent for the prevention of delayed emesis in chemotherapy-naïve cancer patients receiving cyclophosphamide, doxorubicin, and/or cisplatin. Using the maximum tolerated dose of olanzapine in the phase I trial, a phase II trial was performed for the prevention of chemotherapy-induced nausea and vomiting in chemotherapy-naïve patients. The regimen was 5 mg/day of oral olanzapine on the 2 days prior to chemotherapy, 10 mg on the day of chemotherapy, day 1, (added to intravenous granisetron, 10 mcg/kg and dexamethasone 20 mg), and 10 mg/day on days 2-4 after chemotherapy (added to dexamethasone, 8 mg p.o. BID days 2 and 3, and 4 mg p.o. BID day 4). Thirty patients (median age 58.5 years, range 25-84; 23 women; ECOG PS 0, 1) consented to the protocol, and all were evaluable. Complete response (CR) (no emesis, no rescue) was 100% for the acute period (24 h postchemotherapy), 80% for the delayed period (days 2-5 postchemotherapy), and 80% for the overall period (0-120 h postchemotherapy) in ten patients receiving highly emetogenic chemotherapy (cisplatin > or =70 mg/m(2)). CR was also 100% for the acute period, 85% for the delayed period, and 85% for the overall period in 20 patients receiving moderately emetogenic chemotherapy (doxorubicin > or =50 mg/m(2)). Nausea was very well controlled in the patients receiving highly emetogenic chemotherapy, with no patient having nausea [0 on scale of 0-10, M.D. Anderson Symptom Inventory (MDASI)] in the acute or delayed periods. Nausea was also well controlled in patients receiving moderately emetogenic chemotherapy, with no nausea in 85% of patients in the acute period and 65% in the delayed and overall periods. There were no grade 3 or 4 toxicities and no significant pain, fatigue, disturbed sleep, memory changes, dyspnea, lack of appetite, drowsiness, dry mouth, mood changes, or restlessness experienced by the patients. Complete response and control of nausea in subsequent cycles of chemotherapy (25 patients, cycle 2; 25 patients, cycle 3; 21 patients, cycle 4) were equal to or greater than cycle 1. Olanzapine is safe and highly effective in controlling acute and delayed chemotherapy-induced nausea and vomiting in patients receiving highly and moderately emetogenic chemotherapy.

Administration, Oral↗

PubMed2001

Altretamine for the treatment of metastatic renal cell carcinoma. A Hoosier Oncology Group trial.

Thirty patients with advanced renal cell carcinoma were treated on a phase 11 trial with altretamine. Altretamine was administered orally at a dosage of 260 mg/m2 days 1 through 14 with cycles repeated every 28 days. Nausea and vomiting were the most common toxicities. Ten percent (3 of 30) experienced Grade 3 gait abnormalities. None of the thirty evaluable patients achieved a complete or partial response. In summary, altretamine did not show antitumor activity in the treatment of advanced renal cell carcinoma.

Adult↗

PubMed2001

Comparing methods for monitoring serum creatinine to predict late renal allograft failure.

Few studies have systematically investigated what changes in chronic renal allograft function best predict subsequent graft failure, when these changes occur, and whether they occur soon enough to allow possible intervention. We collected serum creatinine values (mean, 183 +/- 75 values/patient) measured over a maximum follow-up of 22 years in 101 consecutive renal transplant recipients (excluding creatinine levels from periods of acute rejection). We determined the dates of first decline in inverse creatinine (Delta1/Cr; < -20%, -30%, -40%, -50%, and -70%), declines in estimated creatinine clearance (CCr; <55, 45, 35, 25, and 15 mL/min), and declines in measured slope of 1/Cr over time. We used time-dependent covariates in Cox proportional hazards analyses to determine the relative effect of each renal function parameter on outcomes while adjusting for other risk factors. The best predictor of subsequent graft failure was Delta1/Cr. Delta1/Cr less than -40% first occurred at a median of 1.28 years after transplantation in 73 patients, and 67 patients went on to have graft failure a median of 3.28 years after Delta1/Cr less than -40%. The independent relative risk for graft failure attributable to Delta1/Cr less than -40% was 5.91 (95% confidence interval, 3.25 to 10.8; P < 0.0001). A decline in CCr, eg, less than 45 mL/min, also was a strong predictor of subsequent graft failure. Conversely, declines in allograft function estimated from slopes of 1/Cr were poor predictors of graft failure. In analysis limited to patients followed up for 2.5 years or less, Delta1/Cr continued to predict graft failure, suggesting that Delta1/Cr will be a useful predictor in populations with shorter follow-up. If confirmed in other populations, eg, patients treated with calcineurin inhibitors, this simple marker of chronic allograft dysfunction may prove to be a practical tool for defining patients at high risk for late graft failure.

Adolescent↗

PubMed1998

Ifosfamide in the treatment of advanced or recurrent squamous cell carcinoma of the head and neck: a phase II Hoosier Oncology Group trial.

The Hoosier Oncology Group conducted a trial evaluating ifosfamide in patients who had recurrent or metastatic squamous cell carcinoma of the head and neck. Patients must have received no prior chemotherapy for metastatic disease. If prior adjuvant chemotherapy was given, the last cycle must have been at least six months from time of recurrence. All patients were required to have a Karnofsky performance status of > or = 50. Twenty-four patients received treatment consisting of ifosfamide, 1.5 g/m2/day for 5 days, with cycles repeated every 3 weeks. Mesna, 300 mg/m2, was administered intravenously 15 minutes before ifosfamide and 4 and 8 hours after ifosfamide on days 1 through 5. Toxicity was predominantly hematologic, with grade 3--4 neutropenia seen in 13 patients resulting in 4 episodes of neutropenic fever. One partial response was seen in 23 evaluable patients for an overall response rate of 4.3% (95% confidence interval, 0, 12.7%). In conclusion, ifosfamide would appear to have limited single-agent activity in squamous cell carcinoma of the head and neck.

Adult↗

PubMed1996

A phase II study of weekly oral methotrexate and zidovudine (AZT) in advanced adenocarcinoma of the pancreas and hepatocellular carcinoma.

From January 1992 through May 1993, 31 patients with adenocarcinoma of the pancreas or hepatocellular carcinoma were treated with weekly oral methotrexate (7.5 mg/M2 every 6 hours for 6 doses) and continuous oral AZT (200 mg four times daily). Patients were treated for a total of 6 months or until disease progression. The median age was 66 (range 44-79) and the median KPS was 80. No patient had received prior chemotherapy. Hematologic toxicity was severe with 50% of patients developing hemoglobins less than 8 gm/dl and 70% with granulocyte counts less than 1000 per mm3. One patient achieved a radiographic complete remission and 2 had stable disease. Two-thirds of patients progressed within 2 months of beginning therapy. The combination of methotrexate and AZT is an inactive regimen in pancreatic and hepatocellular carcinoma and is associated with considerable toxicity.

Adenocarcinoma↗

PubMed1996

Synthesis of oligonucleotides labelled with 2,4-dinitrophenyl groups at thymidine sites.

A phosphoramidite has been produced for labelling oligonucleotides with DNP groups at thymidine sites during solid-phase synthesis. The dinitrophenylamino group is attached via a caproamidopropargyl group to the 5-position of uracil. A related DNP-labelling phosphoramidite has been synthesised where the propargyl group is replaced by propyl. Both phosphoramidites have been used to synthesises DNP-labelled oligonucleotides. A related DNP-labelled deoxyuridine triphosphate has also been synthesised. DNP labelled oligonucleotide probes are valuable in diagnostic applications for the antibody-based detection of DNA and RNA.

Chromatography, High Pressure Liquid↗

PubMed1996

Antibody-mediated detection and physical properties of oligonucleotides labelled with multiple internal and terminal 2,4-dinitrophenyl groups.

DNP-labelled phosphoramidites have been used to synthesis oligonucleotides with multiple DNP reporter groups. The antibody-mediated detection and the stability of duplexes formed by these labelled oligonucleotides have been studied. A DNP-labelled deoxyuridine triphosphate has also been used to enzymatically incorporate DNP-labels into DNA via the polymerase chain reaction. The use of DNP-labelled primers in the PCR has also been investigated.

Antibodies↗

PubMed1992

Phase III trial of cyclophosphamide versus cyclophosphamide, doxorubicin, and methotrexate in hormone-refractory prostatic cancer. A Hoosier Oncology Group study.

BACKGROUND: Between August 1984 and November 1989, the Hoosier Oncology Group conducted a Phase III study comparing cyclophosphamide (CTX) with cyclophosphamide, doxorubicin, and methotrexate (CAM) in patients with hormone-refractory metastatic prostatic cancer to determine whether the addition of doxorubicin and methotrexate to the cyclophosphamide regimen conferred any survival advantage. METHODS: One hundred three patients were registered and randomized, 99 were evaluable for response, and all were evaluable for survival results. All had histologically confirmed metastatic prostatic cancer and had not responded to hormonal therapy. Fifty-three patients received CTX alone, and 50 received CAM. Seventy-one patients (69%) had evaluable disease, and 32 (31%) had measurable disease. RESULTS: There were no complete responses and only four (13%) partial responses in the patients with measurable disease. There was no difference in overall survival time between the two treatment arms in either patients with a Karnofsky performance status (KPS) of 80-100 (median survival, 9.0 versus 9.5 months; P = 0.93) or in those with a KPS of 50-70 (median survival, 5.0 versus 6.0 months; P = 0.51). There was no difference in overall time to progression between the two treatment arms (median time to progression; 4.4 versus 6.2 months; P = 0.07). Toxicity was tolerable in both regimens. CONCLUSIONS: It was concluded that there was no survival advantage to CAM over CTX alone. New chemotherapeutic agents with greater activity against prostatic cancer must be identified.

Aged↗

PubMed1990

Phase II trial of daily oral VP-16 in refractory small cell lung cancer: a Hoosier Oncology Group study.

Twenty-six previously treated patients with refractory small cell lung cancer (SCLC) were entered into a Hoosier Oncology Group phase II trial of daily oral etoposide 50 mg/m2/d. Twenty-five patients had prior exposure to cisplatin plus etoposide, and 14 of the 26 patients (54%) had prior therapy with CAV (cyclophosphamide, doxorubicin, and vincristine). Nonhematologic toxicity was mild; the dose-limiting toxicity was granulocytopenia. One complete response and five partial responses were seen (duration, 6 to 20 weeks), for an overall response rate of 23%. We conclude that daily oral etoposide is a well-tolerated and easily administered drug in refractory SCLC and has definite therapeutic activity.

Administration, Oral↗

PubMed1989

Unexplained second trimester oligohydramnios: a clinical-pathologic study.

The importance of oligohydramnios in the absence of fetal malformations has been recognized because of the associated high risk for adverse pregnancy outcome. Pathologic dissections were performed on four fresh fetuses whose mothers were identified by ultrasound as having oligohydramnios and had no clinical history or physical evidence of vaginal leakage of amniotic fluid. The fetuses were all normal except for hypoplasia of the lungs and varying degrees of Potter's facies. The kidneys were histologically normal but had increased weight. The more widespread use of ultrasound may have allowed us to detect an earlier stage of a previously present type of pregnancy failure.

Abortion, Induced↗