Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
Completed · Phase 2
Conditions studied: HIV Infections, Hodgkin's Disease
In brief
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.
Key facts
- Study ID
- NCT00000626
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 27
- Expected to finish
- 1999-02-01
- Last updated by the study team
- 2021-10-27
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Alabama Therapeutics CRS — Birmingham, Alabama, United States
- USC CRS — Los Angeles, California, United States
- Northwestern University CRS — Chicago, Illinois, United States
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
- St. Louis ConnectCare, Infectious Diseases Clinic — St Louis, Missouri, United States
- Washington U CRS — St Louis, Missouri, United States
- SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States
- The Ohio State Univ. AIDS CRS — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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