Phase III Randomized Trial of Low-Dose m-BACOD vs Standard-Dose m-BACOD/GM-CSF in Patients with AIDS-Associated non-Hodgkin's Lymphoma (Summary Last Modified 11/92)
Basic Trial Information
|Phase III||Treatment||Closed||12 and over||NIAID||NIAID-ACTG-142|
I. Compare the survival of patients with AIDS-associated non-Hodgkin's lymphoma treated with low-dose m-BACOD (MTX/BLEO/DOX/CTX/VCR/DM) vs. standard-dose m-BACOD with granulocyte-macrophage colony stimulating factor. II. Compare the complete response rate, degree of toxicity, durability of response, and incidence of opportunistic infections in those patients treated with these two regimens.
Histologically or cytologically proven non-Hodgkin's lymphoma of one of the following histologies: Diffuse large cell lymphoma Large cell immunoblastic lymphoma Small noncleaved cell lymphoma All stages eligible HIV seropositivity by any commercially available technique required No active opportunistic infection requiring antibiotic therapy other than Mycobacterium avium complex Coincident infection must be ruled out in patients with systemic B symptoms or diarrhea persisting longer than 2 weeks No primary CNS lymphoma
Biologic therapy: No immunomodulating agents within 2 weeks of entry Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent experimental medication No concurrent zidovudine Recovery from toxicity of any prior medication required Dideoxyinosine may be continued on study except during treatment with allopurinol No requirement for systemic administration of potentially myelosuppressive drugs (e.g., ganciclovir, trimethoprim/sulfamethoxazole, or pyrimethamine/sulfadoxine)
Age: 12 and over Patients under 18 years of age must receive care under the supervision of a pediatric oncologist Performance status: Karnofsky 60-100% Hematopoietic: ANC at least 1,000 Platelets greater than 75,000 (unless cytopenias are caused by lymphoma) Hepatic: Bilirubin less than 2.0 mg/dl unless elevation is caused by liver involvement with lymphoma Transaminases less than 5 x ULN Renal: Creatinine no greater than 2.0 mg/dl OR Creatinine clearance at least 60 ml/min Other: No prior or concurrent second malignancy except: Curatively treated basal cell skin cancer Curatively treated cervical cancer Kaposi's sarcoma (unless rapidly progressive or there is known peripheral edema or visceral Kaposi's sarcoma) Negative pregnancy test required within 2 weeks of entry of fertile women Adequate contraception required of fertile women
250 evaluable adults (age 18 and over) will be entered at a rate of 150-200/year. It is anticipated that accrual will be completed in 1.5 years and that follow-up will require at least an additional year.
Randomized study. Patients with lymphomatous meningitis at presentation begin CNS treatment on Regimen A concomitantly with chemotherapy. Arm I: 6-Drug Combination Systemic Chemotherapy with Leucovorin Rescue plus Single-Agent Intrathecal Chemotherapy. m-BACOD: Methotrexate, MTX, NSC-740; Bleomycin, BLEO, NSC-125066; Doxorubicin, DOX, NSC-123127; Cyclophosphamide, CTX, NSC-26271; Vincristine, VCR, NSC-67574; Dexamethasone, DM, NSC-34521; with Leucovorin calcium, CF, NSC-3590; plus Intrathecal Cytarabine, IT ARA-C, NSC-63878. Low-dose m-BACOD. Arm II: 6-Drug Combination Systemic Chemotherapy with Leucovorin Rescue and Hematopoietic Stimulation plus Single-Agent Intrathecal Chemotherapy. m-BACOD; with CF; Granulocyte-Macrophage Colony Stimulating Factor (Schering), GM-CSF, NSC-617589; plus IT ARA-C. Standard-dose m-BACOD. Regimen A: Single-Agent Intrathecal Chemotherapy plus Radiotherapy. Intrathecal MTX, IT MTX; plus cranial irradiation (equipment unspecified).
Kaplan L, Straus D, Testa M, et al.: Randomized trial of standard dose mBACOD with GM-CSF vs reduced dose mBACOD for systemic HIV-associated lymphoma: ACTG 142. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-818, 288, 1995.
Trial Contact Information
Trial Lead Organizations
AIDS Clinical Trials Group
Ph: 415-353-2661; 800-888-8664
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.