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Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole, Zidovudine (AZT), and Granulocyte Colony Stimulating Factor (G-CSF) in Patients With AIDS-Related Lymphoma, Phase II

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole, Zidovudine (AZT), and Granulocyte Colony Stimulating Factor (G-CSF) in Patients With AIDS-Related Lymphoma, Phase II

OBJECTIVES: I. Assess the response rate of AIDS-related lymphoma to ProMACE-CytaBOM
(cyclophosphamide, doxorubicin, etoposide, 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.

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 etoposide 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.

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

Inclusion 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

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

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for lymphoma

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

every 3 months while on protocol treatment

Safety Issue:


Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University


United States: Federal Government

Study ID:




Start Date:

June 1994

Completion Date:

July 2011

Related Keywords:

  • Lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related diffuse large cell lymphoma
  • AIDS-related immunoblastic large cell lymphoma
  • AIDS-related small noncleaved cell lymphoma
  • AIDS-related diffuse mixed cell lymphoma
  • AIDS-related diffuse small cleaved cell lymphoma
  • Lymphoma
  • Lymphoma, AIDS-Related



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Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
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CCOP - Montana Cancer ConsortiumBillings, Montana  59101
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