Phase I and II evaluation of cytembena in disseminated epithelial ovarian cancers and sarcomas.
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Acrylates↗
Biomedical subjects
M K Samson
Publications and source records attributed to M K Samson.
Phase I clinical trial of combined therapy with vinblastine (NSC-49842), bleomycin (NSC-125066), and cisdichlorodiammineplatinum(II)( NSC-119875).
Seventeen patients with various histologic types of incurable malignant disease were treated with a combination of vinblastine, bleomycin, and cis-dichlorodiammineplatinum(II). Creatinine and blood urea nitrogen elevations were noted but were not of a severe degree. White blood cell and platelet count depressions were seen and appeared to be cumulative, though not life-threatening. Tinnitus and high-frequency hearing loss were noted. Tumor regression was seen in one patient with adenocarcinoma of the lung and in one patient with a testicular tumor. This appears to be a manageable drug combination with frequent monitoring of renal, hematopoietic, pulmonary, and auditory function. A phase II study establishing the therapeutic efficacy of this combination in advanced testicular neoplasms now appears to be indicated.
Adult↗
Phase 1-11 study of DTIC and cyclocytidine in disseminated malignant melanoma.
Seventeen patients with disseminated malignant melanoma were treated with DTIC (150 mg/m2, Days 1-5) and cyclocytidine (increasing doses sc, Days 1-10) in a phase I-II study. There was one early death. The remaining 16 patients were evaluable for response and toxicity. Two patients (13%) had CR lasting 8+ and 2+ months, while one patient (6%) had a PR lasting 1 month. Nausea and vomiting was seen in seven patients (44%), jaw pain in four (25%), and orthostatic hypotension in two (13%). Hematologic toxicity was not excessive, nor was it cumulative. The overall response rate of 19% was comparable to that reported with DTIC alone. This drug combination does not appear to offer any therapeutic advantage within the dosage range tested in disseminated malignant melanoma.
Adult↗
Acquired hypertrichosis languiginosa. Report of two new cases and a review of the literature.
Hypertrichosis lanuginosa is a pathologic state characterized by an excessive, new growth of fine, fetal hair. Two cases of hypertrichosis languinosa with malignancy (lymphoma and uterine cancer) are presented and added to the 9 in the literature. Lymphoma and uterine cancer are previously unreported as associated with hypertrichosis osis lanuginosa. Review of the 11 cases of hypertrichosis lanuginosa revealed the following characteristics: females were predominant; none was below the 4th decade; all had advanced neoplastic disease; all malignancies except one were of epithelial origin; and there were no demonstrable endocrine abnormalities. Despite an attempt to find etiologic factors in our patients and in the literature, none could be elicited.
Adenocarcinoma↗
Response of patients with carcinoma of the breast to hormonal therapy and combination chemotherapy.
Of the 89 patients with disseminated carcinoma of the breast treated with combination or sequential cyclophosphamide, fluorouracil and vincristine, 63 had received evaluable course of endocrine therapy and chemotherapy. The response to endocrine therapy, regardless of its nature or duration, failed to predict response to subsequent chemotherapy. Selection of the patients on the basis of pretreatment disease free interval, menopausal status or metastatic pattern showed the groups of patients to be homogeneous in distribution. In addition, evaluation for a disease free interval greater or less than two years, menopausal status and visceral or nonvisceral metastasis did not allow identification of groups predicting responsiveness to combination chemotherapy.
Adrenalectomy↗
Granulocyte transfusions collected from normal donors.
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Agranulocytosis↗
Evaluation of amonafide in disseminated malignant melanoma. A Southwest Oncology Group study.
Amonafide (AMF), NSC 308847 is an investigational anticancer drug acting as a DNA intercalating agent. This paper presents results of a phase II clinical study of AMF in disseminated malignant melanoma. Twenty patients, eleven males and nine females, with biopsy proven malignant melanoma, performance status 0-2; median age 59 (range 29-74), and no previous chemotherapy, were treated with AMF 300 mg/m2/day by 60 min i.v. infusion for five days repeated every three weeks. Fifteen patients had lung (9 patients) and/or liver (8 patients) involvement. None had known brain metastasis at entry. All 20 patients were evaluated for response and toxicity. Six patients had stable disease and fourteen had increasing disease. With 0/20 responses, the upper 95% confidence limit for the response rate was 14%. The median survival time was 5.7 months. Hematologic toxicity was dose limiting with the incidence of leucopenia 45% and thrombocytopenia 20%. The nonhematologic toxicities included nausea and vomiting (60%), alopecia (20%), headaches (15%), diarrhea (10%), and phlebitis (10%). We conclude that AMF administered at this dose and schedule is not active in the treatment of patients with malignant melanoma, previously untreated with chemotherapy.
Adenine↗
Combination chemotherapy with mitomycin C, adriamycin, and cyclophosphamide in advanced adenocarcinoma and large cell carcinoma of the lung.
Thirty-six patients with advanced carcinoma of the lung (30 with adenocarcinoma and six with large cell carcinoma) were treated with a combination of mitomycin C, Adriamycin, and cyclophosphamide (MAC) in a phase II study. Seven partial remissions were observed in adenocarcinomas, while none were seen in large cell carcinomas. The survival of patients in remission was clearly prolonged (P less than 0.01), with responders living a median of at least 39 weeks compared to 17 weeks for nonresponders. The combination was well-tolerated with moderate anorexia, nausea, vomiting, and alopecia. Myelosuppression was manageable but was more pronounced in previously chemotherapeutically treated patients. MAC offers a reasonable response rate in patients with adenocarcinoma of the lung with significant prolongation of survival; however, there was no significant advantage when compared to mitomycin C used as a single agent.
Adenocarcinoma↗
Phase II evaluation of cis-dichlorodiammineplatinum(II) in advanced malignancies of the genitourinary and gynecologic organs: a Southwest Oncology Group Study.
One hundred and forty-seven fully and partially evaluable patients with advanced measurable malignancies of the genitourinary and gynecologic organs were given cis-dichlorodiammineplatinum(II) at a dose of 75 mg/m2 iv every 3 weeks. Thirty-six patients with testicular neoplasms were studied; five complete responses (13.9%) and seven partial responses (PR) (19.4%) were noted. Thirty-seven patients with ovarian adenocarcinoma were evaluated; five PRs (13.5%) were seen. One complete response (11.1%) and two PRs (22.2%) were obtained among nine patients with urinary bladder cancer. Four PRs (19.0%) were seen among a group of 21 patients with advanced prostate cancer. One PR (4.8%) was noted among 21 patients with renal cell cancer and no responses were seen in eight patients with cervical cancer. There was a highly statistically significant (P less than 0.001) survival advantage for the responding testicular tumor patients. Toxicity was similar to that previously reported, with gastrointestinal side effects and nephrotoxicity most commonly seen. Prospective and sequential analysis of renal function provided strong evidence for cumulative nephrotoxicity in these patients given bolus injections of cis-dichlorodiammineplatinum(II) without prehydration or treatment with fuosemide or mannitol.
Cisplatin↗
Phase I study of 5-azacytidine (NSC-102816) using 24-hour continuous infusion for 5 days.
The biologic and antitumor activity of 5-azacytidine has been well demonstrated in the past. The drug at present is thought to be primarily cell cycle phase specific. This study was designed to eliminate undesirable side effects (mainly nausea and vomiting) occurring with a bolus dose and to confirm the recent findings of the relative stability of 5-azacytidine's solution with preserved biologic and antitumor activity. In the study we determined that a dose of 150 mg/m2/day given as a 120-hour continuous iv infusion and repeated at 28-day intervals produced safe, manageable, and reproducible toxicity. The drug was freshly prepared at 4-hour intervals. Eleven courses were administered to seven patients at this dose level and no patient experienced nausea or vomiting. Leukopenia was the major toxic effect. Antitumor activity was shown in one patient with colon cancer and another with American Burkitt's lymphoma.
Adult↗
Cis-dichlorodiammineplatinum(II) in advanced soft tissue and bony sarcomas: a Southwest Oncology Group Study.
cis-Dichlorodiammineplatinum(II) (DDP), at a dose of 15 mg/m2/day x 5 consecutive days, was administered to 68 evaluable patients with metastatic soft tissue and bony sarcomas. All patients, except one, had received extensive prior chemotherapy and had had progressive disease at the start of the study. Responses observed included one complete response in a patient with mesothelioma and three partial responses in patients with soft tissue sarcomas (7%). No responses were seen in 18 patients with bony sarcomas. Significant leukopenia and thrombocytopenia were observed in less than 20% of evaluable courses, although two patients manifested life-threatening leukopenia (less than 1000 cells/microliter) and three had life-threatening thrombocytopenia (less than 24,000 cells/microliter). Nephrotoxicity was noted in less than 25% of evaluable courses. Nausea and/or vomiting was recorded in 55% of evaluable courses. DDP is considered to be marginally active in the secondary treatment of metastatic sarcomas at this dose and schedule. Further studies of DDP in mesothelioma are indicated.
Adolescent↗
Mitomycin C and bleomycin in the treatment of far-advanced cervical cancer: a Southwest Oncology Group pilot study.
Under the auspices of the Southwest Oncology Group, Wayne State University tested a schedule using bleomycin and mitomycin C that was previously reported to give a response rate of 88%. In our patients the same regimen produced similar toxic effects but a far different response rate of 15.8% (one complete remission and two partial remissions). The only discernible difference in the two patient groups was the amount of radiation given prior to chemotherapy.
Bleomycin↗
Phase II study of AMSA in lung cancer.
Ninety-one assessable patients with advanced oat cell and non-oat cell carcinoma of the lung were given AMSA on an intermittent every-3-week schedule. Starting doses ranged from 55 to 120 mg/m2, depending on the presence and severity of hepatic dysfunction. Three partial responses (two squamous cell carcinomas, one adenocarcinoma) of short duration were documented. The major toxic effect was leukopenia (44%). AMSA does not appear to have sufficient antitumor activity to warrant further investigation in advanced lung cancer.
Adenocarcinoma↗
Combination chemotherapy with cyclophosphamide, vincristine, methyl-CCNU, and bleomycin in advanced bronchogenic carcinoma: experience with 106 patients.
A phase II study was conducted with three different combinations of cyclophosphamide, Oncovin (vincristine), methyl-CCNU, and bleomycin (COMB) in 106 patients with advanced bronchogenic carcinoma of all histologies. The response rates were 27.3% for COMB I (six of 22 patients), 18.2% for COMB II (eight of 44 patients), and 7.5% for vincristine, methyl-CCNU, and bleomycin (three of 40 patients). Complete responses were seen only in the small cell carcinoma group. Duration of remission and overall survival were of significance for the small cell group, whereas survival for the other histologic types comparing responders to nonresponders was of no statistical significance. Toxicity was significant and included nausea and vomiting, neuropathy, and myelosuppression. These drug combinations were disappointing and only in small cell carcinoma was meaningful antitumor activity seen.
Antineoplastic Agents↗
Phase II evaluation of cycloleucine in the treatment of patients with disseminated sarcomas.
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Adult↗
Vinblastine, bleomycin, and cis-dichlorodiammineplatinum(II) in disseminated testicular cancer: preliminary report of a Southwest Oncology Group Study.
Combination induction chemotherapy consisting of vinblastine, bleomycin, and cis-dichlorodiammineplatinum(II) was administered to 126 patients with advanced germ cell tumors of the testis. Following this 4-month induction therapy, maintenance treatment consisting of chlorambucil and actinomycin D alternating monthly with vinblastine was given for an additional 20-month period. Sixty-four patients (51%) achieved a complete remission, while 33 patients (26%) achieved a partial response. Responses were observed in all histologic categories. Seven patients (11%), who were in complete remission, have relapsed at a median time of 5 months. Median duration of remission is greater than 12 months for complete responders and 4 months for partial responders. Significant leukopenia was noted in 57% of evaluable courses and significant thrombocytopenia was noted in 18%. Less than 20% of patients were noted to have nephrotoxicity. Other toxic effects observed were gastrointestinal (42%), dermatologic (15%), pyrexia (14%), neuromuscular (9%), and pulmonary (less than 5%). Several pretreatment parameters are currently being evaluated to determine the impact on complete remission rate and survival.
Antineoplastic Agents↗