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PubMed1990

[Treatment of condyloma acuminata using human lymphoblastoid interferon].

Eighteen cases of condyloma acuminata were treated by human lymphoblastoid interferon (HLBI). Seventeen were male and one was female. Five cases were recurrent cases. Except one patient, all the patients were administered HLBI by intralesional injection. Five patients were treated by single injection. Others were given 2 to 8 injections during one to 5 weeks. Total dose varied from 3 x 10(6) to 24 x 10(6) U. Of the eighteen patients, 6 showed a complete response and 3 a partial response (greater than 50% reduction in size of the lesion). In 5 of the 11 patients (45%) who were treated with a total dosage of more than 12 x 10(6) U, the lesion was completely cleared. Six patients who showed a complete response did not experience recurrent disease during the 6-month follow-up period. In conclusion, intralesional administration of HLBI for condyloma acuminata proved to be effective.

Adolescent↗
PubMed1992

Treatment of cutaneous squamous cell carcinomas by intralesional interferon alfa-2b therapy.

BACKGROUND AND DESIGN: Intralesional recombinant interferon alfa-2b has been shown to be effective in the treatment of actinic keratoses and basal cell carcinomas. This open-label study was designed to evaluate the effectiveness and cosmetic result of this therapy on actinically induced, primary cutaneous squamous cell carcinomas. Thirty-six squamous cell carcinomas (28 invasive lesions and 8 in situ lesions) ranging in size from 0.5 to 2.0 cm in the longest dimension were treated with interferon alfa-2b 1.5 million units injected intralesionally three times per week for 3 weeks. Eighteen weeks following therapy, the treatment sites were excised and examined for histologic evidence of remaining tumor. RESULTS: Thirty-three (97.1%) of 34 evaluable lesions revealed an absence of squamous cell carcinoma histologically after therapy, although three biopsy specimens (8.8%) obtained after treatment showed actinic keratoses, for an overall complete response rate of 88.2%. The lesion not eliminated after treatment was an invasive squamous cell carcinoma. The investigators and patients independently judged 93.9% of cases to have a very good or excellent cosmetic result. Adverse reactions were limited to those influenzalike symptoms well recognized to occur with interferon therapy and these were well tolerated. Only one patient discontinued therapy due to side effects. CONCLUSIONS: This trial demonstrates that intralesional interferon is effective in the treatment of small sun-induced squamous cell carcinomas with well-tolerated side effects and a highly acceptable cosmetic result.

Adult↗
PubMed2004

Is cidofovir a useful adjunctive therapy for recurrent respiratory papillomatosis in children?

OBJECTIVE: To assess the usefulness of cidofovir in treating recurrent respiratory papillomatosis in children. Cidofovir is an acyclic nucleoside phosphonate that has been reported to be effective in the treatment of respiratory papillomatosis in several small series of patients. METHODS: A prospective study was conducted in 11 children (mean, 2.1 years; range, 0.5-3 years at diagnosis) with recurrent respiratory papillomatosis who at the start of the study were requiring debridement of papillomas at least every 6 weeks. After microlaryngoscopy with powered microdebridement of papillomas patients received intralesional injection of cidofovir (5mg/ml). The severity of papillomatosis was rated at each visit using a standardized papilloma severity scoring system. The success of therapy was measured by the trend in the patient's papilloma severity scores before and after cidofovir therapy and by whether the frequency of operative interventions decreased in the period after treatment began. RESULTS: Three patients had impressive improvements in severity scores and a decrease in the frequency of required operative interventions after cidofovir, two patients had a partial response, and for six patients cidofovir was considered ineffective. CONCLUSIONS: Intralesional cidofovir did not decrease the severity or frequency of operative intervention for recurrent respiratory papillomas in the majority of children in this study. The drug did improve papillomatosis in the minority of patients without causing notable morbidity. A large multi-institutional controlled study is needed to better assess the efficacy of this treatment.

Antineoplastic Agents↗
PubMed2002

Intralesional vinblastine vs. 3% sodium tetradecyl sulfate for the treatment of oral Kaposi's sarcoma. A double blind, randomized clinical trial.

In this double-blind, randomized trial, we compared the clinical efficacy of intralesional vinblastine (VNB) and 3% sodium tetradecyl sulfate (STS) in the treatment of oral Kaposi's sarcoma (OKS). Subjects with OKS were randomly assigned to receive a single intralesional injection of either VNB or STS, at a standard dose (0.2 mg/cm(2)). Differences were evaluated by the Mann-Whitney U and Fisher's exact tests. Sixteen HIV-infected patients were included, eight received VNB and eight received STS; clinical response was evaluated at days 7, 14, and 28 following treatment. Tumor size reduction was 0.68 and 0.61 cm in the VNB and STS groups, respectively (P=0.80). Two VNB patients had complete or partial response whereas four STS subjects had partial responses (P=0.61). Patients in both groups experienced minimal toxicity. We conclude that intralesional vinblastine or STS are adequate for the management of OKS. The benefits of STS are its low cost and ease of use.

Adult↗
PubMed1991

Intralesional interferon alfa-2b in the treatment of basal cell carcinoma. Immunohistochemical study on cellular immune reaction leading to tumor regression.

Four patients with basal cell carcinomas were treated with intralesional injections of interferon alfa-2b (1.5 million IU per injection) three times a week for 2 weeks. Histopathologic examination of biopsy specimens of the lesions confirmed the absence of basal cell carcinoma in all cases 4 weeks after completion of therapy. A dense mononuclear cell infiltrate and numerous ectatic blood vessels were present in the dermis at the sites of previous basal cell carcinoma. Immunohistologic analysis of the dermal infiltrate revealed a marked increase of Leu-4+ T cells with a slight predominance of Leu-3+ helper/inducer T cells over Leu-2+ suppressor/cytotoxic T cells. Most of the dermal infiltrate expressed HLA-DR antigen. In addition, Leu-11+ natural killer cells were observed in the dermal infiltrate. Immunohistologic changes in the skin lesions at the sites of previous basal cell carcinoma suggest that intralesional interferon alfa-2b acts on tumor cells by enhancement of local T-cell-mediated immune responses.

Aged↗
PubMedDate not supplied

Radioguided-surgery of early breast lesions.

BACKGROUND: Radioguided-surgery has been recently proposed in patients with clinically occult breast lesions. This study aimed to evaluate the feasibility of correctly locating and eradicating, by a single intralesional injection of a radiotracer, any breast lesion and, in the case of malignancy, to perform simultaneous sentinel lymph node (SLN) biopsy procedure. PATIENTS AND METHODS: Sixty-three women with early breast lesions were enrolled: 42 were invasive carcinomas, 16 in situ ductal carcinomas (DCIS) and 5 fibroadenomas. RESULTS: Scintigraphic images clearly identified the lesions in all patients while SLN/s were evident in 88% of them. At surgery all the breast lesions were easily radiolocalized and eradicated with minimum surgical trauma and, for those patients with invasive carcinomas, the SLN technique was performed in 86% of them. No skip metastases were found. CONCLUSION: A single intralesional administration of radiotracer is an easy and reliable procedure to simultaneously locate and remove both the non-palpable breast lesion and the SLN when primary malignancy was intraoperatively confirmed.

Adult↗
PubMed1996

Antisense oligonucleotide intralesional therapy for human PC-3 prostate tumors carried in athymic nude mice.

Previously we reported hemorrhagic necrosis in human-derived PC-3 prostate tumors, in athymic nude mice, produced by the intralesional injection of antisense oligonucleotides (oligos) directed against mRNAs encoding transforming growth factor-alpha (TGF-alpha) and its target, the epidermal growth factor receptor (EGFR). We now describe our experience with these oligos in treating additional mice with various doses and modes of administration. During prolonged treatment, a dose-response effect was observed, with the optimal dosage consisting of the combination of 400 micrograms of each oligo. Although responses varied, based upon amount and how oligos were administered, we found that tumors were best treated when initially less than 156 mm3. Intralesional inoculations produced necrosis and yielded responses, ranging from complete response (CR) or cure to partial responses (PR) in 9 of 12 tumors treated with full dose (400 micrograms of each oligo) and 1 of 1 treated with 800 micrograms of each oligo, against a large tumor. Included among the 9 positive responses with full-dose administration were 2 tumors that regressed (one completely). A single tumor treated with twice (2X) the normal dosage (800 micrograms of each oligo) also regressed. A single tumor treated with half (1/2) dose (200 micrograms of each) progressed similar to controls, as did 3 of 12 treated with the full dose. Limited experience with ALZET diffusion pumps gave CR (1 of 3) or PR (2 of 3) in 100% of tumors treated (including one mouse cured of multiple tumors in a five day period). It appears that multiple inoculations consisting of 400 micrograms of each oligo is most effective against these tumors, particularly when administered against tumors of <156 mm3 in initial size.

Animals↗
PubMed2000

Lattice intrahepatic doxorubicin with and without in-flow occlusion: a pharmacokinetic study of direct liver injection.

AIM: To assess possible improvements in drug delivery to unresectable liver tumours we investigated the pharmacokinetics of intrahepatic doxorubicin in the dog liver with and without inflow occlusion. METHODS: Using a lattice template, doxorubicin was injected into 16 sites (over a 9 cm2 area) in each of three lobes of the liver for a total of 48 sites. The total doses of doxorubicin used were 4.8 mg and 96 mg (0.1 and 2 mg/site). Dogs with intravenous and intra-arterial delivery of the same total doses of doxorubicin were used as controls. Experiments using intrahepatic injection were performed with and without a 30 min occlusion of the hepatic artery, common bile duct and portal vein (inflow occlusion). The studies with vascular stasis were performed to determine if drug clearance from the injection sites and their plasma levels were reduced. Also, it was observed that blood and drug loss along the needle tract was reduced when inflow occlusion was used. Plasma and liver samples were harvested over a 90-min period and analysed by high pressure liquid chromatography (HPLC). RESULTS: In plasma mean peak levels and mean area under the curve (AUC) were significantly lower with intrahepatic doxorubicin (P<0.05) than with intravenous or intra-atrial delivery. In the liver AUCintrahepatic/AUCintravenous ratios were 3.45 and 3.6 with 4.8 mg and 96 mg of doxorubicin respectively. The AUCintrahepatic/AUCintraarterial ratios were 1.97 and 1.65 respectively. The liver extraction ratio (AUCliver/AUCplasma) after intravenous administration with 4.8 mg and 96 mg of doxorubicin was 31.9 with both doses of doxorubicin. The corresponding extraction ratios were 107.6 and 51 for intra-arterial administration and 425.2 and 237.7 for intrahepatic administration for the two doses of doxorubicin. Intrahepatic injection with inflow occlusion minimized the leakage back along the needle-tracts. The liver visibly retained the injected drug more completely. However, there was a decrease in systemic clearance resulting in a reduction of the pharmacological advantage. CONCLUSION: These results indicate that lattice-intrahepatic administration of doxorubicin into the liver using a lattice template was associated with a significant increase in local and decrease in systemic exposure as compared to intravenous or intra-arterial administration of the same doses. Simultaneous occlusion of arterial and portal venous inflow was not shown to improve regional drug delivery. These pharmacokinetic studies may constitute a basis for palliative treatment of liver tumours by lattice intralesional injection when these cancers are found to be unresectable at the time of exploratory surgery.

Animals↗
PubMed2003

Phase II clinical trial of intralesional administration of the oncolytic adenovirus ONYX-015 in patients with hepatobiliary tumors with correlative p53 studies.

PURPOSE: ONYX-015 is a genetically modified adenovirus with a deletion of the E1B early gene and is therefore designed to replicate preferentially in p53-mutated cells. A Phase II trial of intralesional ONYX-015 was conducted in patients with hepatobiliary tumors to determine the safety and efficacy of such a treatment. EXPERIMENTAL DESIGN: All patients had biopsy-proven, measurable tumors of the liver, gall bladder, or bile ducts that were beyond the scope of surgical resection. Patients received intralesional injections of ONYX-015 at either 6 x 10(9) or 1 x 10(10) plaque-forming units/lesion up to a total dose of 3 x 10(10) plaque-forming units, and i.p. injections were allowed in patients with malignant ascites. The status of p53 was assessed by immunohistochemistry or Affymetrix GeneChip microarray analysis. Studies were conducted for viral shedding and for the presence of antiadenoviral antibodies before and after the injection of ONYX-015. Patients were assessed for response and toxicity. RESULTS: Twenty patients were enrolled, and 19 patients were eligible. Half of the patients had primary bile duct carcinomas. Serious toxicities (> grade 2) were uncommon and included hepatic toxicity (three patients), anemia (one patient), infection (one patient), and cardiac toxicity (one patient, atrial fibrillation). Sixteen patients were evaluable for response. Among these evaluable patients, 1 of 16 (6.3%) had a partial response, 1 of 16 (6.3%) had prolonged disease stabilization (49 weeks), and 8 of 16 (50%) had a >50% reduction in tumor markers. Of the 19 eligible patients, 18 (94.7%) had specimens available for p53 analysis. Fifteen of these 18 patients (83.3%) had evidence of p53 mutation by one or both methods, although the methods correlated poorly. Viral shedding was confined to bile (two of two patients) and ascites (four of four patients). Pretreatment adenoviral antibodies were present in 14 of 14 patients and increased by 33.2% after ONYX-015 treatment. CONCLUSIONS: Intralesional treatment with ONYX-015 in patients with hepatobiliary tumors is safe and well tolerated, and some patients had evidence of an anticancer effect. The high incidence of p53 mutations in these tumors makes this a logical population in which to test this therapy but precludes definitive evaluation about the necessity of a p53 mutation for ONYX-015 clinical activity.

Adenoviridae↗
PubMed2003

Intralesional cidofovir for the treatment of severe juvenile recurrent respiratory papillomatosis: long-term results in 4 children.

OBJECTIVE: We sought to determine the efficacy of intralesional injection of cidofovir in improving resolution of recurrent respiratory papillomatosis (RRP). Study design and setting We conducted a prospective, observational trial at an academic tertiary children's hospital. RESULTS: Four children with RRP requiring more than 6 surgical excisions per year were treated with intralesional cidofovir. Cidofovir (5 mg/mL) was injected into airway sites where papillomas had just been excised using sharp technique. Each patient had 6 treatments performed 6 to 8 weeks apart. Biopsies confirmed benign papilloma lesions in all cases. During treatment with intralesional cidofovir there was diminished growth of the papillomas in each patient. Once cidofovir treatment was stopped, the rate of regrowth and frequency of surgical excision returned to pretreatment levels in 3 of the 4 patients. CONCLUSIONS: Intralesional cidofovir may provide benefit in reducing the rate of RRP growth while under treatment, but RRP severity returned to pretreatment levels once cidofovir treatment was stopped using this treatment program.

Antiviral Agents↗
PubMed1994

Intralesional beta-interferon treatment of cervical intraepithelial neoplasia associated with human papillomavirus infection.

AIMS AND BACKGROUND: Interferons (IFN) have offered considerable advances in the therapy of genital warts even those associated with cervical intraepithelial neoplasia (CIN); intralesional therapy either alone or in combination with other modalities such as cryosurgery and laser surgery provides improved clearing and cure of these often recalcitrant lesions. The purpose of this study was to evaluate the effectiveness of intralesional IFN therapy in patients with CIN associated with human papillomavirus (HPV) infection. METHODS: Beta-IFN was injected intra-perilesionally into the cervix in 41 patients with CIN associated with HPV infection. RESULTS: The regimen of 3 million international units (IU) injected intralesionally daily in the 1st week and 3 times a week in the 2nd and 3rd weeks for a total of 11 injections and a total dosage of 33 million IU yielded an 80 percent cure rate and may be more advantageous than other treatment options in certain instances. Cytocolposcopic and histologic examination was carried out before and after treatment and 24 lesions were also analyzed for type-specific papillomaviruses using in situ DNA hybridization. CIN disappeared in 33 patients 6 months after the end of therapy. Side effects of intralesional IFN therapy are dose related and for the most part readily tolerated. CONCLUSIONS: Intralesional IFN proved to be effective treatment for CIN associated with HPV infection (cure rate: 80%) and well accepted because hospitalization is not required and no important side effects occur.

Adult↗
PubMedDate not supplied

The efficacy of treatment with triamcinolone acetonide in calcinosis cutis following extravasation of calcium gluconate: a preliminary study.

Neonatal hypocalcemia is not an uncommon condition, especially in the premature neonate. It is effectively treated by intravenous administration of calcium gluconate. Complications of extravasation during intravenous infusion include localized calcification and occasionally necrosis. When this occurs, however, there is no specific mode of treatment except supportive management and skin graft. This experiment was designed to evaluate the efficacy and safety of treatment with triamcinolone acetonide in calcinosis cutis following extravasation of calcium gluconate. Initially, 2 cc of 10% calcium gluconate was injected subcutaneously into two rabbits at seven sites on the shaved skin of the back. Another two rabbits were injected at the same sites with 0.5 cc of triamcinolone acetonide (10 mg/dl) after injection of 2 cc of 10% calcium gluconate. As a control, 2 cc of normal saline was injected into another rabbit in the same manner. These five rabbits were observed over the next 7 weeks and underwent pathologic examination at various intervals (on days 1, 3, 8, 15, 30, 37, 45). In the 10% calcium gluconate injected rabbits, nodules and large ulcerated lesions developed after 15 days. Multiple, linear, ulcerative and indurated masses were noted on day 37. The lesions healed progressively with a decrease in ulceration, and after 2 months, the masses disappeared gradually. Histologically, on day 15 calcium deposits were seen in the walls of the arteries, veins, dermis, and muscle fibers and epidermal necrosis was seen at the injection sites. From day 37 discharge of calcium deposits began to take place by means of transepidermal elimination. After 2 months, the calcium and mucin deposition was observed focally in the dermis. In the rabbits injected with 10% calcium gluconate and triamcinolone acetonide, mild erythema and induration were seen after day 15 at the injection sites; this gradually disappeared. After 30 days the injection sites were normal in appearance. Histologically, at day 15 calcium deposition was seen in the upper dermis, but after 1 month the injection sites were histologically normal. We suggest that intralesional injection of triamcinolone acetonide for the treatment of calcinosis cutis following extravasation of calcium gluconate is effective, probably due to its antiinflammatory effect and its role in facilitating the resorption of calcium in the tissue.

Administration, Topical↗
PubMed1997

Development of intralesional therapy with fluorouracil/adrenaline injectable gel for management of condylomata acuminata: two phase II clinical studies.

OBJECTIVES: To evaluate a sustained release chemotherapy for treating condylomata acuminata with an injectable gel containing fluorouracil and adrenaline (5-FU/adrenaline gel). Study 1-- To assess contributions of the components of 5-FU/adrenaline gel to efficacy. Study 2--To assess therapeutic contribution of adrenaline and safety and efficacy of the formulations. DESIGN: Randomised, double blind, placebo controlled studies. SETTING: Private practices and university clinics in the United States. PATIENTS: Men and women with new, recurrent, or refractory external condylomata acuminata. INTERVENTION: Six injections over 8 weeks; follow up visits at weeks 1, 4, 8, and 12. MAIN OUTCOME MEASURES EFFICACY: patient/wart response, times to complete response, recurrence rates. SAFETY: injection reactions, tissue conditions, other adverse events, laboratory studies. RESULTS: Study 1: 132 evaluable patients. Complete response (CR) rate was highest for the 5-FU/adrenaline gel group, followed by the 5-FU/adrenaline solution group, then the 5-FU gel group. 5-FU, adrenaline, and the collagen gel vehicle (in the presence of 5-FU) significantly affected CR and strongly influenced time to CR. The effects of 5-FU and adrenaline were statistically significant. Cutaneous reactions were mild to moderate. Study 2: 187 evaluable patients. Patients treated with 5-FU/adrenaline gel had a significantly higher CR rate and lower cumulative 90 day recurrence rate than those treated with 5-FU gel without adrenaline. Treatments were generally well tolerated, with only three treatment related, serious adverse events. CONCLUSION: 5-FU/adrenaline gel is safe and efficacious for treatment of condylomata acuminata, and when compared with individual or various combinations of components, this formulation provided the greatest therapeutic advantage.

Adolescent↗
PubMed1996

[Association of interleukin 2 and interferon alpha in the management of cervical condylomatosis].

At present the therapy of cervical condylomatosis is based on the use of interferon because the HPV types responsable for condyloma inhibit the immunitary system. But many A. studying the effects of IFN have found that at high concentration it has an immunosuppressive action. The aim of the present study was to evaluate if interleukin-2 associated with IFN is useful in avoiding this negative effect by improving the efficacy of cervical condylomatosis therapy. We treated 25 women suffering from cervical condyloma with increasing doses of IL-2 injected intralesionally and associated with natural alpha-IFN injected intramuscularly. The duration of the whole therapy was six weeks. We evaluated the percentage of inflammatory cells in peripheral blood before and after treatment. The per-cent number of lymphocytes, eosinophils and lymphoblasts was increased by 27%, 88% and 40%, respectively. The clinical response to the therapy was total in 14 cases, partial in 9 cases and unsuccessful in 2 cases. These data suggested that combination therapy with interleukin-2 and alpha-IFN for the treatment of patients with cervix condylomatous is successful.

Adult↗
PubMed1990

Immunohistological evaluation of basal cell carcinoma immunoinfiltrate during intralesional treatment with alpha 2-interferon.

We investigated the peritumoral and intratumoral immune infiltrate in 6 basal cell carcinomas (BCCs) treated with recombinant alpha 2b-interferon. Each BCC was injected intralesionally three times a week for 3 weeks with 1.5 x 10(6) IU of interferon per injection (total dose 13.5 x 10(6) IU). The immunohistological study was done before the start of interferon therapy and 15 days afterwards, using a series of monoclonal antibodies and an immunocytochemical technique. Before therapy the infiltrate consisted mainly of CD3+ (T) cells, with prevalence of CD4+ (helper/inducer) T cells. The percentage of T cells expressing interleukin-2 receptor (CD25+ cells) was higher in the tumor nests than in the peritumoral infiltrate (20% and 11% respectively). CD1+ (Langerhans) cells and CD14b+ cells (monocytes/macrophages) were present in the peritumoral infiltrate in all cases (9% +/- 5% and 14% +/- 7% respectively). Very few CD56+ (natural killer), CD15+ (granulocytes) and CD20+ (B) cells were observed in the peritumoral infiltrate and none at all in tumor nests. After 15 days of interferon therapy, we observed an increase in peritumoral and intratumoral CD4+ cells. There was a decrease in the number of CD25+ cells and of CD1+ cells in the peritumoral infiltrate. The number of intratumoral CD25+ increased. No variations were seen in CD14b, CD15, CD20, and CD56 positive cells. Eight weeks after completion of therapy, two BCCs were cleared and the remaining four showed clinical and histological improvement. These results may indicate a direct effect of interferon against BCC; in addition the immunohistological findings suggest that intralesional interferon enhances T cell mediated immune response, especially in tumor nests.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1983

Bleomycin in the treatment of recalcitrant warts.

Bleomycin is gaining increasing popularity in the treatment of warts, but its efficacy has not been examined in well-controlled studies. We evaluated bleomycin in a double-blind placebo-controlled crossover study in recalcitrant warts treated unsuccessfully by conventional methods. Patients were assigned alternately to placebo or bleomycin groups and treated by intralesional injections of bleomycin, 1 U/ml, or saline, at 2-week intervals. If warts persisted, patients were changed after two injections to the alternate group and retreated with up to two further injections. Forty patients entered the study. Of 151 warts treated with intralesional bleomycin, 123 were cured after one or two injections (81%). The cure rate for plantar warts (60%) was lower than that for periungual warts (94%) and warts elsewhere on the extremities (95%). Fifty-five warts were injected with normal saline; none was cured. Responding warts showed a hemorrhagic eschar and healed without scarring, atrophy, or pigmentary change. Pain was usually mild and patient acceptance superior to that with liquid nitrogen. There was no evidence of systemic toxicity. Bleomycin is highly efficacious in the treatment of recalcitrant warts, is convenient, and has high patient acceptance. Long-term safety requires further study.

Bleomycin↗