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

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.

Conditions

• Lymphoma

Interventions

BIOLOGICAL

bleomycin sulfate

5u/m2 IV Q21days x 6 cycles

BIOLOGICAL

filgrastim

5ug/kg SC, Days 9-20, Q 21 days x 6 cycles

DRUG

cyclophosphamide

490 mg/m2 IV Q 21 days x 6 cycles

DRUG

cytarabine

225 mg/m2 IV Q 21 days x 6 cycles

DRUG

doxorubicin hydrochloride

19 mg/m2 IV Q 21 days x 6 cycles

DRUG

etoposide

90 mg/m2 IV Q 21 days x 6 cycles

DRUG

leucovorin calcium

25 mg/m2 po 24 hours after methotrexate Q 6 hours x 4 doses for 6 cycles.

DRUG

methotrexate

90 mg/m2 IV, Q 21 days x 6 cycles.

DRUG

prednisone

60 mg/m2 po QD x 14days for 6 cycles

DRUG

trimethoprim-sulfamethoxazole

1 double throughout strength treatment tablet po on Monday, Wednesday, and Friday x 6, 21 day cycles

DRUG

vincristine sulfate

1.4 mg/m2 IV Q 21 Days x 6 cycles

RADIATION

radiation therapy

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.

DRUG

Intrathecal cytarabine

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Lode J. Swinnen, MD · Loyola University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1994-06-30

Primary Completion

2003-11-30

Completion

2011-07-31

Countries

• United States

Study Locations