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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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

Study drugs are administered in 28-day cycles to twenty-seven HIV-infected patients with Hodgkin's disease. ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) is administered on days 1 and 15 of each cycle, and G-CSF is given on days 2 through 14 and 16 through 28 of each cycle. All patients receive four cycles of treatment and are then restaged. Patients with a complete response (CR) following the initial four ...

Gender

ALL

Eligibility 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.