Showing papers by "Joan H. Schiller published in 1989"

Granulocyte-Macrophage Colony-Stimulating Factor and Vasculitis

Abstract: Excerpt To the Editor:Recombinant granulocyte-macrophage colony-stimulating factor (rGM-CSF) is now being widely used in clinical trials. Reported toxic effects include fever, nausea and vomiting, ...

A phase I trial of interferon-α-2a plus cyclophosphamide, vincristine, prednisone, and doxorubicin

Abstract: We conducted a Phase I trial of interferon-alpha-2a (IFN-alpha-2a) plus combination chemotherapy consisting of cyclophosphamide, vincristine, prednisone, and doxorubicin (COPA) in order to determine the maximum dose of IFN-alpha-2a that could be administered without compromising the dose intensity of COPA. Twenty-one patients received IFN-alpha-2a intramuscularly on days 1-5, followed by 600 mg/m2 cyclophosphamide intravenously (i.v.) on day 8; 50 mg/m2 doxorubicin i.v. on day 8; 1.2 mg/m2 vincristine i.v. on day 8; and 100 mg/m2 prednisone orally on days 8-12. IFN doses were escalated between patient groups; 7 patients received 12 x 10(6) U/m2, 11 patients received 6 X 10(6) U/M2, and 3 patients received 12 X 10(6)/m2. Because 79% of the cycles of COPA administered at the third dose level required a delay for hematologic recovery, further patient accrual at this dose level ceased. Grade III or IV granulocytopenia occurred on day 1 in 6, 9, and 0 of the patients treated at the three dose levels. Granulocyte counts rapidly recovered, however, and did not result in a delay in chemotherapy administration on day 8 in 94% of the cycles at the first two dose levels. The mean hematocrit following five cycles of therapy dropped from 40 to 31%. Only two patients required dose reductions due to constitutional symptoms related to the IFN-alpha-2a. Eight responses were observed, including five of five patients with nonHodgkin's lymphomas, one of five with melanoma, one of six with renal cell carcinoma, and one of one with adenoid cystic carcinoma. One patient with metastatic melanoma remains in a complete response on maintenance IFN-alpha-2a for three years. We conclude that 6 X 10(6) U/m2 of IFN-alpha-2a can be administered to cancer patients without significantly compromising the dose intensity of COPA. This observation, and the demonstrated activity of IFN-alpha-2a plus COPA (I-COPA) in low and intermediate grade histology nonHodgkin's lymphomas, provides the basis for the randomized Phase III trial comparing COPA to I-COPA in these neoplasms, which is currently being conducted in the Eastern Cooperative Oncology Group.

A pilot study of short-course, high-dose cytosine arabinoside, etoposide, and cisplatin in refractory, aggressive-histology, non-Hodgkin's lymphomas

Abstract: Twenty-three patients with refractory, aggressive-histology, non-Hodgkin's lymphomas were treated with cytosine arabinoside (2.0 g/m2 i.v. every 12 h on days 1 and 2), etoposide (100 mg/m2 i.v. on days 1 and 2), and cisplatin (35 mg/m2 i.v. on days 1 and 2) every 3 weeks. All patients had received one or two prior chemotherapy regimens. Five of 19 (26%) evaluable patients responded, with a median duration of response of 9 weeks (90% confidence interval: 11-48%). One patient with a complete response remains free of disease over 31 months after completing six cycles of therapy. Six transient responses of less than 1-month duration were also observed. Hematological toxicity was significant: 73% of patients experienced grade 4 neutropenia, and 52% experienced grade 4 thrombocytopenia. Twenty patients (87%) underwent dose reductions following their first cycle of therapy for grade 3 or 4 myelosuppression. We conclude that this combination of drugs, when administered by this schedule, has limited antitumor activity; however, administering the regimen with a dose-intense schedule appears warranted.