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

• Status: Completed
• Trial end date: 1999-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease.

Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen.

Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Amgen
• Treatments: Bleomycin; Dacarbazine; Doxorubicin; Lenograstim; Liposomal doxorubicin; Vinblastine

Criteria

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.