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


Phase 2
12 Years
N/A
Not Enrolling
Both
HIV Infections, Hodgkin's Disease

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Principal Investigator

Levine A

Investigator Role:

Study Chair

Authority:

Unspecified

Study ID:

ACTG 149

NCT ID:

NCT00000626

Start Date:

Completion Date:

February 1999

Related Keywords:

  • HIV Infections
  • Hodgkin's Disease
  • Granulocyte Colony-Stimulating Factor
  • Acquired Immunodeficiency Syndrome
  • Antineoplastic Agents, Combined
  • AIDS-Related Complex
  • Hodgkin Disease
  • ABVD protocol
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Hodgkin Disease

Name

Location

Alabama Therapeutics CRSBirmingham, Alabama  35294
USC CRSLos Angeles, California  90033
Northwestern University CRSChicago, Illinois  60611
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
St. Louis ConnectCare, Infectious Diseases ClinicSt Louis, Missouri  63112
Washington U CRSSt. Louis, Missouri  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
The Ohio State Univ. AIDS CRSColumbus, Ohio  43210