Search / Trial NCT00000660

Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma

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

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Trial Information

Current as of December 07, 2023

Completed

Keywords

Sarcoma, Kaposi Drug Evaluation Etoposide Acquired Immunodeficiency Syndrome

Description

VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy. Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain, inconvenience, and potential complications associated with medications administered intravenously. The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivate...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • AMENDED:
  • 04-21-91 Zidovudine (AZT) allowed after completing 8 weeks on the study. Patients on reduced doses of VP-16 must have tolerated at least 4 consecutive weeks at the reduced dose before starting AZT. Zidovudine will not be provided by the NIAID Clinical Product Research Repository.
  • AMENDED:
  • Zidovudine (AZT) allowed after completing 12 weeks on study.
  • Allowed:
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis (PCP).
  • Concurrent Treatment:
  • Allowed:
  • Local radiotherapy or laser therapy to cosmetically apparent, non-indicator lesions provided the dose to any one lesion does not exceed 300 rads and the total surface area of all lesions treated does not exceed 10 cm2.
  • Risk Behavior:
  • Allowed:
  • All risk groups.
  • Patients must:
  • Have AIDS-related Kaposi's sarcoma.
  • Be ineligible for protocols of higher priority at study center.
  • Be willing to sign an informed consent or have guardian willing to sign.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active opportunistic infection not specifically allowed.
  • Concurrent neoplasm not specifically allowed.
  • Significant neurologic, cardiac, or liver disease.
  • Concurrent Medication:
  • Excluded:
  • Therapy with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs for an opportunistic infection.
  • Patients with the following are excluded:
  • Active opportunistic infection not specifically allowed.
  • Ongoing therapy, including maintenance therapy, for an opportunistic infection with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs.
  • Concurrent neoplasm not specifically allowed.
  • Significant neurologic, cardiac, or liver disease.
  • Prior Medication:
  • Excluded:
  • Biologic response modifiers or corticosteroids within 14 days prior to study entry.
  • Cytotoxic chemotherapy within 30 days prior to study entry.
  • Ribavirin within 6 weeks prior to study entry.
  • Azidothymidine (AZT), alpha-interferon, didanosine (ddI), ganciclovir (DHPG), or any other antiretroviral drugs within 1 week prior to study entry.
  • Prior Treatment:
  • Excluded within 30 days prior to study entry:
  • Radiation therapy with > 4000 rads.
  • Total skin electron beam therapy.

Attachments

readout_NCT00000660_2023-12-07.pdf

4.5 MB

NCT00000660_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

New York, New York, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

New York, New York, United States

Rochester, New York, United States

New York, New York, 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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3 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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