Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Amgen

Conditions:

HIV Infections

Hodgkin's Disease

Eligibility:

All Genders

12+ years

Phase:

PHASE2

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 ...

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 administer...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

February 1 1999

Estimated Enrollment :

27 Patients enrolled

Trial Details

Trial ID

NCT00000626

End Date

February 1 1999

Last Update

October 27 2021

Active Locations (8)

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Page 1 of 2 (8 locations)

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