Search / Trial NCT00000626

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Granulocyte Colony Stimulating Factor Acquired Immunodeficiency Syndrome Antineoplastic Agents, Combined Aids Related Complex Hodgkin Disease Abvd Protocol

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 ...

Gender

All

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.

Attachments

readout_NCT00000626_2024-03-02.pdf

4.5 MB

NCT00000626_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

Los Angeles, California, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

Columbus, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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