Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00002571

SWOG-9320 Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Antiviral therapy may be effective treatment for AIDS-related lymphoma.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and antiviral therapy in treating patients who have AIDS-related lymphoma.

Eligibility

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

Disease(s) and\or Condition(s)

Lymphoma

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: bleomycin sulfate
    • Description: 5u/m2 IV Q21days x 6 cycles
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: BIOLOGICAL
    • Name: filgrastim
    • Description: 5ug/kg SC, Days 9-20, Q 21 days x 6 cycles
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: cyclophosphamide
    • Description: 490 mg/m2 IV Q 21 days x 6 cycles
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: cytarabine
    • Description: 225 mg/m2 IV Q 21 days x 6 cycles
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: doxorubicin hydrochloride
    • Description: 19 mg/m2 IV Q 21 days x 6 cycles
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: etoposide
    • Description: 90 mg/m2 IV Q 21 days x 6 cycles
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: leucovorin calcium
    • Description: 25 mg/m2 po 24 hours after methotrexate Q 6 hours x 4 doses for 6 cycles.
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: methotrexate
    • Description: 90 mg/m2 IV, Q 21 days x 6 cycles.
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: prednisone
    • Description: 60 mg/m2 po QD x 14days for 6 cycles
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: trimethoprim-sulfamethoxazole
    • Description: 1 double throughout strength treatment tablet po on Monday, Wednesday, and Friday x 6, 21 day cycles
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: vincristine sulfate
    • Description: 1.4 mg/m2 IV Q 21 Days x 6 cycles
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: RADIATION
    • Name: radiation therapy
    • Description: All patients achieving a CR or PR following systemic therapy and IT Ara-C, will receive 2,400 cGy in two hundred cGy fractions to the whole brain. Fields should adequately encompass all meningeal surfaces.
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
    • Type: DRUG
    • Name: Intrathecal cytarabine
    • Description: If initial bone marrow positive: Ara-C 30 mg/m2 IT per dose x 5 doses spaced evenly during the first two cycles of therapy. Ara-C 30 mg/m2 IT Day 1 of each subsequent cycle. If initial CSF cytology positive: Ara-C 30 mg/m2 IT per dose x 5 doses spaced evenly during the first cycle of therapy. If CSF negative after above, Ara-C 30 mg/m2 IT Day 1 of each subsequent cycle. If CSF positive after initial five doses of Ara-C, IT MTX 12 mg per dose x 5 doses should be given spaced evenly during the second cycle of therapy. If initial bone marrow and CSF negative: Ara-C 30 mg/m2 IT per dose x 5 doses to be given spaced evenly within 1 month of completion of systemic therapy.
    • Arm Group Labels: ProMACE-CytaBOM + G-CSF
Sponsor
  • SWOG Cancer Research Network