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)

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed12 and overNIAIDNIAID-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.

Entry Criteria

Disease Characteristics:

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
  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

No primary CNS lymphoma

Prior/Concurrent Therapy:

Biologic therapy:
  No immunomodulating agents within 2 weeks of entry

  No prior chemotherapy

Endocrine therapy:
  Not specified

  Not specified

  Not specified

  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

Patient Characteristics:

  12 and over
     Patients under 18 years of age must receive care under the
     supervision of a pediatric oncologist

Performance status:
  Karnofsky 60-100%

  ANC at least 1,000
  Platelets greater than 75,000
  (unless cytopenias are caused by lymphoma)

  Bilirubin less than 2.0 mg/dl unless elevation is caused by
     liver involvement with lymphoma
  Transaminases less than 5 x ULN

  Creatinine no greater than 2.0 mg/dl OR
  Creatinine clearance at least 60 ml/min

  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

Expected Enrollment

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).

Published Results

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

Lawrence Kaplan, MD, Protocol chair
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.