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Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Amgen
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000626
  Purpose

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 Intervention Phase
HIV Infections
Hodgkin's Disease
Drug: Vinblastine sulfate
Drug: Dacarbazine
Drug: Filgrastim
Drug: Bleomycin sulfate
Drug: Doxorubicin hydrochloride
Phase II

Study Type: Interventional
Study Design: Treatment, Efficacy Study
Official Title: Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 27
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000626

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 900331079
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Illinois Masonic Med Ctr
Chicago, Illinois, United States, 606575147
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Massachusetts
Boston Med Ctr
Boston, Massachusetts, United States, 02118
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, United States, 63112
United States, New York
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Mount Sinai Med Ctr
New York, New York, United States, 10029
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
United States, Ohio
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Sponsors and Collaborators
Amgen
Investigators
Study Chair: Levine A
  More Information

Publications:
Study ID Numbers: ACTG 149
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000626     History of Changes
Health Authority: Unspecified

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Granulocyte Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome
Antineoplastic Agents, Combined
AIDS-Related Complex
Hodgkin Disease
ABVD protocol

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Vinblastine
Infection
Antibiotics, Antineoplastic
Therapeutic Uses
Alkylating Agents
Retroviridae Infections
Hodgkin Disease
Lymphoma
RNA Virus Infections
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Mitosis Modulators
Acquired Immunodeficiency Syndrome
Antimitotic Agents
Bleomycin
Pharmacologic Actions
Immunologic Deficiency Syndromes
Doxorubicin
Virus Diseases
Lymphatic Diseases
Neoplasms
HIV Infections
Tubulin Modulators
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 22, 2009