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Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

Primary Purpose

HIV Infections, Hodgkin's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vinblastine sulfate
Dacarbazine
Filgrastim
Bleomycin sulfate
Doxorubicin hydrochloride
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, AIDS-Related Complex, Hodgkin Disease, ABVD protocol

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Therapeutics CRS
  • USC CRS
  • Northwestern University CRS
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Washington U CRS
  • SUNY - Buffalo, Erie County Medical Ctr.
  • The Ohio State Univ. AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 26, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00000626
Brief Title
Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
Official Title
Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Amgen

4. Oversight

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hodgkin's Disease
Keywords
Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, AIDS-Related Complex, Hodgkin Disease, ABVD protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
27 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vinblastine sulfate
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Intervention Type
Drug
Intervention Name(s)
Bleomycin sulfate
Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levine A
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Therapeutics CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
SUNY - Buffalo, Erie County Medical Ctr.
City
Buffalo
State/Province
New York
Country
United States
Facility Name
The Ohio State Univ. AIDS CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11035615
Citation
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.
Results Reference
background
Citation
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
Results Reference
background

Learn more about this trial

Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

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