Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

Inclusion Criteria

Concurrent Medication:

Required:

• PCP prophylaxis consisting of Bactrim, aerosolized pentamidine, or dapsone.

Recommended:

• Antiemetic therapy within 30 minutes of chemotherapy.

Allowed:

• Antiretroviral medication after two cycles of chemotherapy, provided the patient has not experienced grade 3 neutropenia while on chemotherapy or on previous antiretroviral therapy.
• Acetaminophen and/or nonsteroidal anti-inflammatory agents.
• Bone marrow-suppressive agents, such as ganciclovir, Fansidar, Bactrim, and dapsone.
• Maintenance therapy for chronic opportunistic infection.

Concurrent Treatment:

Allowed:

• Cranial irradiation (2400 rads) for patients with CNS involvement.

Patients must have:

• Documented HIV infection or diagnosis of AIDS.
• Hodgkin's disease.
• Consent of parent or guardian and have care directly supervised by a pediatric oncologist if under 18 years of age.

Prior Medication:

Allowed:

• Maintenance therapy for opportunistic infections.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Second primary cancer other than Kaposi's sarcoma that does not require systemic therapy, nonmelanomatous skin cancer, Bowen's disease, or carcinoma in situ of the cervix.
• Acute, active bacterial or opportunistic infection requiring ongoing therapy if such therapy has been initiated within the past 2 weeks.
• Known hypersensitivity (e.g., anaphylactoid reaction, bronchospasm) to E. coli-derived proteins.

Prior Medication:

Excluded:

• Prior chemotherapy for Hodgkin's disease.
• Antiretroviral therapy within 2 weeks prior to study entry.

Prior Treatment:

Excluded:

• Prior radiotherapy for Hodgkin's disease.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety