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

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000626
First received: November 2, 1999
Last updated: May 22, 2012
Last verified: May 2012

November 2, 1999
May 22, 2012
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Complete list of historical versions of study NCT00000626 on ClinicalTrials.gov Archive Site
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Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
  • HIV Infections
  • Hodgkin's Disease
  • Drug: Vinblastine sulfate
  • Drug: Dacarbazine
  • Drug: Filgrastim
  • Drug: Bleomycin sulfate
  • Drug: Doxorubicin hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
February 1999
Not Provided

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000626
ACTG 149, 11124
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Amgen
Study Chair: Levine A
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP