Search / Trial NCT00001059

Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

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

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Vincristine Sarcoma, Kaposi Liposomes Doxorubicin Drug Therapy, Combination Granulocyte Colony Stimulating Factor Acquired Immunodeficiency Syndrome Bleomycin Drug Carriers

Description

Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine. Patients are randomized to receive intravenous DOX-SL alone or in combination with vincristine/bleomycin every 2 weeks. Filgrastim ( granulocyte colony-stimulating factor; G-CSF ) may be given as needed for neutropenia. AS PER AMENDMENT 11/7/96: ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • G-CSF.
  • Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ).
  • PCP prophylaxis (required if CD4 count < 200 cells/mm3).
  • Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex.
  • Up to 14 days of metronidazole.
  • Recombinant erythropoietin.
  • Patients must have:
  • Documented HIV infection.
  • Advanced stage Kaposi's sarcoma.
  • No active acute opportunistic infection.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Significant pulmonary insufficiency (unless due to pulmonary KS).
  • Significant cardiac insufficiency.
  • Other active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer.
  • Grade 2 or worse peripheral neuropathy.
  • Altered mental status that prevents informed consent.
  • Active Mycobacterium tuberculosis.
  • Hypersensitivity or allergic reaction to any study drugs or E. coli-derived medications such as filgrastim (G-CSF).
  • Concurrent Medication:
  • Excluded:
  • GM-CSF.
  • Drugs associated with peripheral neuropathy (other than approved antiretrovirals and vincristine).
  • Multi-drug therapy for active Mycobacterium tuberculosis (although isoniazid and pyridoxine is allowed as treatment for a positive PPD, with permission of study chair).
  • Concurrent Treatment:
  • Excluded:
  • Radiation therapy to study marker lesions.
  • Patients with the following prior condition are excluded:
  • Neuropsychiatric history.
  • Prior Medication:
  • Excluded:
  • Any anti-KS therapy within 21 days prior to study entry.
  • Prior systemic therapy with any anthracycline (including liposomal anthracyclines), vincristine, or bleomycin.
  • Any investigational drug (other than those available through Treatment IND and used for FDA-sanctioned purposes) within 14 days prior to study entry.
  • PER AMENDMENT 11/29/95:
  • No more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma.

Attachments

readout_NCT00001059_2024-03-05.pdf

4.5 MB

NCT00001059_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

Los Angeles, California, United States

San Francisco, California, United States

Aurora, Colorado, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Buffalo, New York, United States

New York, New York, United States

St. Louis, Missouri, United States

Honolulu, Hawaii, 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
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20 September 2023

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20 September 2023

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20 September 2023

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Leslie Alexander
20 September 2023

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