Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
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| ClinicalTrials.gov Identifier: NCT00000626 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : May 23, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Hodgkin's Disease | Drug: Vinblastine sulfate Drug: Dacarbazine Drug: Filgrastim Drug: Bleomycin sulfate Drug: Doxorubicin hydrochloride | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 27 participants |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease |
| Actual Study Completion Date : | February 1999 |
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| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000626
| United States, Alabama | |
| Alabama Therapeutics CRS | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| USC CRS | |
| Los Angeles, California, United States, 900331079 | |
| United States, Illinois | |
| Northwestern University CRS | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Missouri | |
| St. Louis ConnectCare, Infectious Diseases Clinic | |
| St Louis, Missouri, United States, 63112 | |
| Washington U CRS | |
| St. Louis, Missouri, United States | |
| United States, New York | |
| SUNY - Buffalo, Erie County Medical Ctr. | |
| Buffalo, New York, United States | |
| United States, Ohio | |
| The Ohio State Univ. AIDS CRS | |
| Columbus, Ohio, United States, 432101228 | |
| Study Chair: | Levine A |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000626 |
| Other Study ID Numbers: |
ACTG 149 11124 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | May 23, 2012 |
| Last Verified: | May 2012 |
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Granulocyte Colony-Stimulating Factor Acquired Immunodeficiency Syndrome Antineoplastic Agents, Combined |
AIDS-Related Complex Hodgkin Disease ABVD protocol |
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Hodgkin Disease Immune System Diseases Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Doxorubicin Liposomal doxorubicin Bleomycin Dacarbazine Vinblastine |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |