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Biomedical subjects

R E Bellet

Publications and source records attributed to R E Bellet.

At least 19 recordsLinked to original sources
PubMed1992

Effective combination chemo/hormonal therapy for malignant melanoma: experience with three consecutive trials.

Our experience with the combination of dacarbazine, carmustine, cisplatin with and without tamoxifen is reported. In our initial study, with all 4 drugs, we had an overall response rate of 50% with a complete response rate of 15%. Due to a high incidence of deep venous thrombosis and the lack of effectiveness of tamoxifen as a single agent, we deleted tamoxifen from the regimen and treated another 20 patients. Surprisingly, the response rate decreased to 10%. We then re-incorporated tamoxifen into the regimen and treated 25 additional patients. In this third group of patients we experienced an objective response rate of 52% with a complete response rate of 8%. Overall, 65 patients have been treated: 45 with and 20 without tamoxifen. Twenty-three (51%) patients treated with tamoxifen have responded, with 5 (11%) patients achieving a complete response. Only 2 (10%) patients treated without tamoxifen have responded. Despite the improvement in the response rate, a corresponding increase in survival has not been seen. Patients treated with tamoxifen had a mean survival of 10.8 (SD 13.6) months compared with a mean survival of 9.8 (SD 7.3) months for those treated without tamoxifen. The absence of survival advantage for the tamoxifen-treated patients may be due to early failure in the central nervous system. In 48% of the responding tamoxifen-treated patients, the first site of failure was the central nervous system, while systemic disease was still responding.

Adult↗
PubMed1989

The importance of tamoxifen to a cisplatin-containing regimen in the treatment of metastatic melanoma.

The combination of dacarbazine (DTIC, 220 mg/m2) and cisplatin (DDP, 25 mg/m2) IV daily for 3 days every 3 weeks, carmustine (BCNU, 150 mg/m2) IV every 6 weeks, and tamoxifen (TAM, 10 mg orally twice daily) produced a 50% objective response rate in patients with metastatic melanoma. Associated with this treatment, there was a high incidence of deep venous thrombosis (DVT) and pulmonary embolism (PE). In an effort to reduce this toxicity, this regimen minus TAM was studied, and the results are reported. Twenty of twenty patients are evaluable for response and toxicity. There was one complete response (CR) lasting 5+ months and one partial response (PR) lasting 4+ months for an overall response rate of 10% (95% confidence limits, 1.23% to 31.70%). Two patients exhibited a mixed response and three patients developed disease stabilization lasting 4 to 10 months. Toxicity was similar to the original study except that no patients developed DVT or PE. This statistically significant (Fisher's exact test [two-tail] P = 0.008) decrease in the response rate by comparison with that achieved with the TAM-containing regimen may signal an essential role of TAM in this regimen. TAM may be acting in synergy with cisplatin through its calcium channel-blocking properties. TAM should be included as described in the initial reports, and the patients should be carefully observed for vascular complications.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1979

Phase II study of ICRF-159 in refractory metastatic breast cancer.

ICRF-159, at a dose of 300 mg/m2, was given orally every 8 hours for nine doses every 21 days to 40 patients with metastatic breast cancer refractory to hormonal therapy and cyclophosphamide, methotrexate, 5-fluorouracil, and adriamycin chemotherapy. Two patients with soft tissue disease had short-lived partial responses. The hematologic toxicity was severe. Three patients required rbc transfusions. Four patients became septic at the nadir of leukopenia; two of these patients died while leukopenic. Two patients had platelet counts less than 25,000/mm3. All patients who were nonevaluable or who had life-threatening or lethal toxicity were nonambulatory. Since the 19 nonambulatory patients had a median survival of only 1.25 months as compared to 7 months in ambulatory patients, it is recommended that future phase II trials in chemotherapy-refractory breast cancer be limited to ambulatory patients. Although ICRF-159 has minimal antineoplastic effects, it is not recommended for further investigations in metastatic breast cancer, even at more hematologically tolerable doses of 250 mg/m2 every 8 hours for nine doses.

Blood Cell Count↗
PubMed1979

Evaluation of a "nude" mouse-human tumor panel as a predictive secondary screen for cancer chemotherapeutic agents.

Nine established human melanoma tissue-cultured cell lines heterotransplanted in C57BL/6 "nude" mice were exposed to each of 4 chemotherapeutic agents of known clinical activity against human melanoma. Two of the therapeutic agents, 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) and 5-(3,3-dimethyl-1-triazino) imidazole-4-carboxamide (DTIC), are known to be active against human melanoma; the other two, adriamycin and 5-azacytidine, are known to be inactive. Sterile saline served as a control agent. In 2 cell line heterotransplants, the control tumor spontaneously regressed. Of the 7 cell lines that remained for evaluation, 4 were sensitive to DTIC, 1 was sensitive to BCNU, and none was sensitive to adriamycin or 5-azacytidine. These data indicate that the nude mouse-human tumor model may be a predictive secondary screen for cancer chemotherapeutic agents.

Animals↗
PubMed1978

Phase II study of subcutaneously administered 5-azacytidine (NSC-102816) in patients with metastatic malignant melanoma.

Thirty (30) patients with advanced metastatic malignant melanoma refractory to DTIC (NSC-45388) and a nitrosourea were treated with 5-azacytidine (NSC-102816). 5-Azacytidine was administered subcutaneously at a dosage of 100 mg/m2/day for 10 days. Twenty-six (26) patients were evaluable for toxicity and response. Major organ toxicities were hematologic, gastrointestinal, and cutaneous; no antitumor activity was noted.

Azacitidine↗
PubMed1978

Positive phase II trial of dibromodulcitol in patients with metastatic melanoma refractory to DTIC and a nitrosourea.

Twenty-five patients with measurable metastatic melanoma refractory to DTIC and a nitrosourea were treated with dibromodulcitol (DBD). DBD was administered orally at bedtime at a dose of 100 mg/m2/day until hematologic toxicity (a greater than or equal to 50% decrease in the wbc or platelet count) was induced. Five patients experienced clinically useful objective remissions; responding lesions included both soft tissue metastases and visceral metastatic disease. It is concluded that DBD is useful in the treatment of patients with metastatic melanoma and thus joins DTIC and the nitrosoureas as single agents which are active against this malignancy.

Adult↗
PubMed1977

A Phase II study of autologous irradiated tumor cells plus BCG in patients with metastatic malignant melanoma.

Eighteen patients with surgically incurable metastatic malignant melanoma were treated with a mixture of irradiated (15,000 rads) autologous tumors cells (1-2 X 10(8)) and BCG (Glaxo, 2-4.5 X 10(6) organisms), which was injected intradermally (in five divided doses) every 2 weeks (X5). Four of 18 (22%) evaluable patients achieved objective remissions. It is concluded that this treatment regimen does not have general clinical application because the remissions were infrequent, of shor duration (median, 3 months) and occurred only in patients with minimal, nonvisceral tumor burdens.

Adult↗
PubMed1977

The phase II evaluation of Bacillus Calmette-Guerin plus megestrol acetate in patients with metastatic renal adenocarcinoma.

The case is reported of a patient with pulmonary metastases from a renal adenocarcinoma who experienced subjective improvement and objective tumor regression on Bacillus Calmette-Guerin (BCG) and megestrol acetate therapy. In a subsequent Phase II trial, no objective responses were noted among 15 patients treated with megestrol acetate (160 mg/day X 56 days) and BCG (five immunizing doses intradermally, every 2 weeks X 5). It is concluded that this treatment regimen is not clinically useful in patients with metastatic renal adenocarcinoma.

Administration, Oral↗