Phase III Comparison of Consolidation with IFN-A vs No Consolidation Following Intensive Induction Chemotherapy with ProMACE-MOPP with or without Radiotherapy in Patients with Stage III/IV Low-Grade non-Hodgkin's Lymphoma
Basic Trial Information
|Phase III||Treatment||Closed||16 and over||NCI||SWOG-8809|
I. Compare the disease-free survival of patients with Stage III or IV low-grade non-Hodgkin's lymphoma randomly assigned to consolidation with interferon alpha vs. no consolidation therapy following intensive induction chemotherapy with ProMACE-MOPP (cyclophosphamide/doxorubicin/etoposide/prednisone/vincristine/nitrogen mustard/procarbazine/methotrexate plus leucovorin rescue) with or without radiotherapy. II. Determine the CR rate, duration of response, and survival of patients with low-grade non-Hodgkin's lymphoma treated with ProMACE-MOPP. III. Compare the toxicities of induction with ProMACE-MOPP (with or without radiotherapy) vs. induction followed by consolidation with interferon in this patient population.
Biopsy-proven low-grade non-Hodgkin's lymphoma: Diffuse, small, lymphocytic Follicular, predominantly small cleaved cell Follicular, mixed small cleaved and large cell Measurable, clinical or pathologic Stage III/IV disease required At a minimum, peripheral hemogram, liver function tests, chest x-ray, abdominal CT, and bone marrow biopsy required for staging Chronic lymphocytic leukemia not eligible No known CNS disease
Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior corticosteroid treatment allowed Radiotherapy: No prior radiotherapy Surgery: Not specified
Age: 16 and over Performance status: SWOG 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no more than 1.7 mg/dl Creatinine clearance at least 60 ml/min Cardiovascular: Normal cardiac function, i.e.: No history of severe heart disease No cardiomyopathy No CHF LVEF at least 50% by MUGA scan (only required if cardiac history is questionable) Other: No prior malignancy that might recur and affect survival No AIDS or HIV-associated complex Blood/body fluid analyses to determine eligibility and imaging studies and physical exams for tumor measurement completed within 14 days prior to registration; screening exams other than blood/body fluid analyses and imaging studies of nonmeasurable disease or uninvolved organs completed within 42 days prior to registration Repeat bone marrow exam required within 42 days of registration if marrow exam negative 6 months prior to entry; if marrow exam positive within 6 months prior to entry and no interim treatment given, repeat marrow exam not required
About 400 patients will have to be entered on Induction therapy in order to have the 252 patients required for randomization. Accrual is anticipated to be complete in about 4 years.
All patients receive Induction chemotherapy on Regimen A, and those in PR with negative bone marrow after chemotherapy receive further Induction therapy with involved field irradiation on Regimen B; patients with PR and positive bone marrow receive additional chemotherapy, after which, if the marrow is negative and they are still in PR, they enter Regimen B. All patients who achieve CR after treatment on either Regimen A or A and B and those patients with PR after treatment on Regimen B are randomized on Arms I and II. Induction. Regimen A: 8-Drug Combination Chemotherapy plus Leucovorin Rescue. ProMACE-MOPP: Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; Etoposide, VP-16, NSC-141540; Mechlorethamine, Nitrogen Mustard, NM, NSC-762; Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; Methotrexate, MTX, NSC-740; plus Leucovorin calcium, CF, NSC-3590. Regimen B: Radiotherapy. Involved field irradiation using megavoltage equipment with minimum energies of Co60 or 2 MV x-rays. Consolidation. Arm I: Biological Response Modifier Therapy. Interferon alpha (Schering), IFN-A, NSC-377523. Arm II: No further treatment.
Fisher RI, Dana BW, LeBlanc M, et al.: Interferon alpha consolidation after intensive chemotherapy does not prolong the progression-free survival of patients with low-grade non-Hodgkin's lymphoma: results of the Southwest Oncology Group randomized phase III study 8809. J Clin Oncol 18 (10): 2010-6, 2000.[PUBMED Abstract]
Dana BW, Unger J, Fisher RI, et al.: A randomized study of alpha-interferon consolidation in patients with low-grade lymphoma who have responded to pro-mace-MOPP (DAY 1--8) (SWOG 8809). [Abstract] Proceedings of the American Society of Clinical Oncology 17: A-10, 1998.
Hsi ED, Rimsza L, Goldman BH, et al.: MUM1 expression in follicular lymphoma is a poor prognostic marker in patients treated with immunochemotherapy (SWOG 9800/9911) but not chemotherapy alone (SWOG 8809): a Southwest Oncology Group correlative science study. [Abstract] Blood 112 (11): A-376, 2008.
Fisher RI, LeBlanc M, Press OW, et al.: New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol 23 (33): 8447-52, 2005.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Southwest Oncology Group
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.