Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
Vinblastine sulfate
+ Dacarbazine
+ Filgrastim
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
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 cycles receive two additional cycles of ABVD / G-CSF. Patients with a partial response following the initial four cycles receive two additional cycles of ABVD / G-CSF and are again restaged; those who have achieved a CR at that point then receive two more cycles, while those without CR discontinue study therapy. Patients with disease progression following the initial four cycles of therapy discontinue treatment on the study. Concomitant PCP prophylaxis is administered.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.27 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
USC CRS
Los Angeles, United StatesNorthwestern University CRS
Chicago, United StatesIndiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, United States