Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	over 18	NCI	SWOG-9320 NCT00002571

Objectives

I.  Assess the response rate of AIDS-related lymphoma to ProMACE-CytaBOM 
(cyclophosphamide, doxorubicin, etopside, prednisone, cytarabine, bleomycin, 
vincristine, methotrexate).

II.  Assess the toxic effects of ProMACE-CytaBOM in patients with AIDS-related 
lymphoma.

III.  Evaluate whether the incorporation of filgrastim (G-CSF) into the 
regimen allows treatment with full doses of the myelotoxic agents in these 
patients.

IV.  Determine whether intensive CNS treatment with intrathecal cytarabine and 
whole-brain irradiation prevents meningeal relapse or controls meningeal 
lymphomatous involvement in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven intermediate or high grade non-Hodgkin's lymphoma of one
of the following histologies:
  Follicular, predominantly large cell
  Diffuse, small cleaved cell
  Diffuse mixed, small and large cell
  Diffuse, large cell (cleaved or noncleaved)
  Immunoblastic, large cell
  Small noncleaved cell, Burkitt's or non-Burkitt's
  No lymphoblastic lymphoma

Prior diagnosis of AIDS or HIV positivity required
  Confirmation of HIV antibody status by Western blot mandatory

Bidimensionally measurable or evaluable disease

No primary CNS lymphoma

Concurrent registration on protocol SWOG-8947 (central serum repository)
required

Prior/Concurrent Therapy:

No prior chemotherapy or radiotherapy for lymphoma

Patient Characteristics:

Age:
  Over 18

Performance status:
  SWOG 0-2

Hematopoietic:
  Absolute neutrophil count at least 500/mm3
  Platelet count at least 75,000/mm3

Hepatic:
  AST no greater than 1.5 times normal
  Alkaline phosphatase no greater than 1.5 times normal
  LDH no greater than 1.5 times normal
  PT/PTT normal

Renal:
  Creatinine no greater than 2.0 times normal
  Creatinine clearance at least 60 mL/min

Cardiovascular:
  No serious abnormalities on EKG
  No history of severe coronary artery disease
  No history of cardiomyopathy, congestive heart failure, or arrhythmia

Other:
  No active uncontrolled infection
  No active second malignancy within 5 years except adequately treated
   nonmelanoma skin cancer or adequately treated carcinoma in situ of the
   cervix
  Not pregnant or nursing 
  Fertile patients must use effective contraception

Expected Enrollment

A total of 50 patients will be accrued for this study over approximately 2 
years.

Outline

Patients are stratified according to participating institution and descriptive 
factors: histopathology (diffuse large cleaved/noncleaved and immunoblastic 
lymphomas vs all others), CD4 count (less than 50 vs 50 or more cells/mm3), 
prior opportunistic infection (yes vs no), performance status (0 and 1 vs 2), 
concurrent AZT (yes vs no), concurrent protease inhibitors (yes vs no), marrow 
involvement (yes vs no).

Patients receive ProMACE-CytaBOM regimen as follows:
 Cyclophosphamide, doxorubicin, and etopside IV on day 1
 Cytarabine, bleomycin, vincristine, and methotrexate IV on day 8
 Oral prednisone on days 1-14
 Oral leucovorin calcium every 6 hours for 4 doses on day 9

Patients also receive filgrastim (G-CSF) subcutaneously on days 9-20 and oral 
co-trimoxazole 3 days a week throughout treatment, plus antiretroviral therapy 
at the discretion of the treating physician. Treatment repeats every 21 days 
for a maximum of 6 courses. 

Patients with progressive disease are removed from study after 2 courses. 
Remaining patients receive an additional 2 treatment courses and are then 
restaged. Patients without stable or progressive disease receive 2 more 
courses in the absence of unacceptable toxicity.

Patients with positive bone marrow at study entry receive CNS prophylaxis with 
5 evenly spaced doses of intrathecal cytarabine during the first 2 treatment  
courses and on day 1 of each subsequent course.

Patients with positive CSF cytology at study entry receive intrathecal 
cytarabine on days 1-5 of the first treatment course and on day 1 of each 
subsequent course if CSF negative after 5 daily doses. Patients whose CSF 
remains positive after 5 days receive 5 evenly spaced doses of intrathecal 
methotrexate during the second treatment course.

Patients with negative bone marrow and CSF cytology at study entry receive 5 
evenly spaced doses of intrathecal cytarabine within 1 month of systemic 
therapy.

All patients achieving a complete or partial response following systemic 
therapy and intrathecal cytarabine receive cranial irradiation to all 
meningeal surfaces. 

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 
months for 1 year, then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Lode Swinnen, MD, Protocol chair(Contact information may not be current)		Ph: 708-216-9000

Registry Information
Official Title		STUDY OF PROMACE-CYTABOM WITH TRIMETHOPRIM SULFAMETHOXAZOLE, ZIDOVUDINE (AZT), AND GRANULOCYTE COLONY STIMULATING FACTOR (G-CSF) IN PATIENTS WITH AIDS-RELATED LYMPHOMA, PHASE II
Trial Start Date		1994-06-08
Registered in ClinicalTrials.gov		NCT00002571
Date Submitted to PDQ		1994-06-08
Information Last Verified		2001-02-01
NCI Grant/Contract Number		U10-CA32102

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