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Phase III Study of G-CSF in the Mobilization of Peripheral Blood Mononuclear Cells (PBMC) and in Stimulating Engraftment of PBMC Following High-Dose Chemotherapy with BCNU/VP-16/CTX in Adult Patients with Relapsed Hodgkin's Disease (Summary Last Modified 11/91)
Basic Trial Information
Objectives I. Determine whether peripheral blood mononuclear cells (PBMC) under the influence of granulocyte colony stimulating factor (G-CSF) can successfully engraft in Hodgkin's disease patients following high-dose chemotherapy with cisplatin/cytarabine/ dexamethasone, and determine whether this engraftment is sustained. II. Determine the number of aphereses necessary to collect 10 x 10 to the eighth mononuclear cells/kg. III. Determine the time to neutrophil and platelet recovery following therapy. IV. Compare the toxicities (e.g., mucositis, azotemia, hyperbilirubinemia) of G-CSF-mobilized PBMC rescue vs. autologous bone marrow therapy. V. Determine whether this regimen costs less than bone marrow transplant. Entry Criteria Disease Characteristics: High-risk Hodgkin's disease, defined as: Recurrent disease following 1 or more regimens of combination chemotherapy (e.g., MOPP or ABVD) Either bone marrow involvement or prior pelvic or other irradiation precluding the use of fractionated TBI required Measurable or evaluable disease required No CNS involvement Prior/Concurrent Therapy: Prior therapy appropriate for the disease is allowed At least 4 weeks since prior therapy Biologic therapy: Not specified Chemotherapy: Failed 1 or more combination regimens (e.g., MOPP or ABVD) No more than 300 mg/sqm doxorubicin Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Patient Characteristics: Age: 18 to 60 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: WBC at least 2,500 ANC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin less than 1.5 x normal Renal: Creatinine less than 1.5 x normal Cardiovascular: Ejection fraction greater than 50% No coronary artery disease Pulmonary: DLCO at least 65% of predicted Other: HIV antibody negative No active skin or autoimmune diseases No prior malignancy except: Curatively treated carcinoma in situ of the cervix Basal cell skin carcinoma No other life-threatening illness No pregnant women Expected Enrollment 40 patients will be entered (20 per arm). If 3 of the first 10 patients fail to reconstitute within 3 weeks of transplant, the study will be stopped. Outline Patients who have failed MOPP only begin treatment on Regimen A; those who have failed MOPP/ABVD begin treatment on Regimen B. All other patients receive cytoreduction therapy on Regimen C. Prior to the second course, patients are randomized on Arms I or II. Patients then proceed to Regimen D. Regimen A: 4-Drug Combination Chemotherapy. ABVD: Doxorubicin, DOX, NSC-123127; Bleomycin, BLEO, NSC-120566; Vinblastine, VBL, NSC-49842; Dacarbazine, DTIC, NSC-45388. Regimen B: 6-Drug Combination Chemotherapy. Stanford V: Mechlorethamine, NM, NSC-762; DOX; BLEO; VBL; Etoposide, VP-16, NSC-141540; Vincristine, VCR, NSC-67574. Regimen C: 3-Drug Combination Chemotherapy: DHAP: Cisplatin, CDDP, NSC-119875; Cytarabine, ARA-C, NSC-63878; Dexamethasone, DM, NSC-34521. Arm I: Peripheral Blood Mononuclear Cell (PBMC) Harvest Following Hematopoietic Stimulation. Multiple leukaphereses following Granulocyte Colony Stimulating Factor, G-CSF, NSC-614629. Arm II: PBMC Harvest without Hematopoietic Stimulation. Regimen D: 3-Drug Combination Myeloablative Chemotherapy with Urothelial Protection followed by Peripheral Stem Cell Rescue and Hematopoietic Stimulation. Carmustine, BCNU, NSC-409962; VP-16, Cyclophosphamide, CTX, NSC-26271; with Mesna, NSC-113891; followed by infusion of PBMC; and G-CSF. Trial Lead Organizations Stanford Cancer Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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