A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:

Required:

- PCP prophylaxis with Bactrim, aerosolized pentamidine, or dapsone.

Allowed:

ddI, except when patient is also taking allopurinol.

Patients must have the following:

- Diagnosis of HIV seropositivity and non-Hodgkin's lymphoma.

- Ability to give informed consent and willingness to comply with all procedures and
visit schedule.

- If between ages of 12 and 18 must receive care under direct supervision of a
pediatric oncologist, and have consent of parent, guardian, or person with power of
attorney.

- Participation in clinical trials of other antiretroviral agents is at the discretion
of the investigator and individual patient.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Active opportunistic infection, excluding Mycobacterium avium complex, requiring
antibiotic therapy.

- Another prior or current malignancy, excepting curatively treated cervical or basal
cell carcinoma.

- Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing
peripheral edema.

- Primary central nervous system lymphoma.

Concurrent Medication:

Excluded:

- Zidovudine (AZT) or any antiretroviral agent unless allowed by investigator. ddI is
allowed except when also taking allopurinol.

Systemic myelosuppressive drugs, including trimethoprim/sulfamethoxazole (T/S),
pyrimethamine/sulfa, or ganciclovir.

-

Patients with the following are excluded:

- Active opportunistic infection, excluding Mycobacterium avium complex, requiring
antibiotic therapy.

- Another prior or current malignancy, excepting curatively treated cervical or basal
cell carcinoma.

- Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing
peripheral edema.

- Primary central nervous system lymphoma.

Prior Medication:

Excluded:

- Immunomodulating agents within 2 weeks of study entry.

Prior Treatment:

Excluded:

- Chemotherapy.

Radiation therapy as outlined in protocol.