Status:
COMPLETED
Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Amgen
Conditions:
HIV Infections
Hodgkin's Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response. Study drugs are administer...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 1999
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00000626
End Date
February 1 1999
Last Update
October 27 2021
Active Locations (8)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
USC CRS
Los Angeles, California, United States, 900331079
3
Northwestern University CRS
Chicago, Illinois, United States, 60611
4
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 462025250