Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	12 and over	NIAID	NIAID-ACTG-142

Objectives

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
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

Prior/Concurrent Therapy:

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)

Patient Characteristics:

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

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.

Outline

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

Lawrence Kaplan, MD, Protocol chair		Ph: 415-353-2661; 800-888-8664 Email: lkaplan@medicine.ucsf.edu