Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
NCT ID: NCT00000626
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
1999-02-28
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Vinblastine sulfate
Dacarbazine
Filgrastim
Bleomycin sulfate
Doxorubicin hydrochloride
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Levine A
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50. doi: 10.1097/00126334-200008150-00009.
Levine AM, et al. Prospective, multicenter phase II trial of ABVD chemotherapy with G-CSF in HIV-infected patients with Hodgkin's disease (HD): AIDS Clincial Trials Group (ACTG) Study 149. Proc Annu Meet Am Soc Clin Oncol. 1997;16:A194
Other Identifiers
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11124
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 149
Identifier Type: -
Identifier Source: org_study_id