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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000626

Collaborator

Amgen (Industry)

Enrollment

Locations

3.4

Patients Per Site

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

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 :

Feb 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Medication:

Required:

PCP prophylaxis consisting of Bactrim, aerosolized pentamidine, or dapsone.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	St. Louis ConnectCare, Infectious Diseases Clinic	Saint Louis	Missouri	United States	63112
6	Washington U CRS	Saint Louis	Missouri	United States
7	SUNY - Buffalo, Erie County Medical Ctr.	Buffalo	New York	United States
8	The Ohio State Univ. AIDS CRS	Columbus	Ohio	United States	432101228