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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000626
• Other study ID #: ACTG 149
• Secondary ID: 11124
• Status: Completed
• Phase: Phase 2
• Est. completion date: February 1999

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Hodgkin Disease
• Hodgkin's Disease

Intervention

Drug:
• Vinblastine sulfate

• Dacarbazine

• Filgrastim

• Bleomycin sulfate

• Doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	Alabama Therapeutics CRS	Birmingham	Alabama
United States	SUNY - Buffalo, Erie County Medical Ctr.	Buffalo	New York
United States	Northwestern University CRS	Chicago	Illinois
United States	The Ohio State Univ. AIDS CRS	Columbus	Ohio
United States	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana
United States	USC CRS	Los Angeles	California
United States	St. Louis ConnectCare, Infectious Diseases Clinic	Saint Louis	Missouri
United States	Washington U CRS	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Amgen

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

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. — View Citation

Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Phase II Study of Figrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15; 24(5): 444-50