A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

To assess toxicity and determine the MTD of intravenous TNP-470 administered weekly in patients with AIDS-related Kaposi's sarcoma. To assess pharmacokinetics and tumor response of the drug.

Since evidence shows that neovascularization is important in the development of Kaposi's sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since evidence shows that neovascularization is important in the development of Kaposi's sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with the disease.

Patients are entered at 7 escalating dose levels of TNP-470. (PER AMENDMENT 9/3/96: dose maximum level changed.) Four patients treated at a given dose level must receive at least 4 weeks of therapy before escalation in subsequent cohorts proceeds. If 50 percent of patients at a given dose level experience dose-limiting toxicity, the previous dose is defined as the MTD and an additional two patients are treated at the MTD. Patients receive treatment for 12 weeks, followed by 2 weeks of rest, followed by an additional 12 weeks of treatment. Patients are followed for 12 weeks post-treatment.

Study Type

Interventional

Enrollment

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC CRS
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Bmc Actg Crs
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess - East Campus A0102 CRS
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington U CRS
    • New York
      • New York, New York, United States
        • Beth Israel Med. Ctr. (Mt. Sinai)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • AZT, ddI, ddC, or d4T provided patients have received at least 2 weeks of this therapy prior to study entry. (Combination ddI/ddC is not permitted.)
  • MAI prophylaxis.

Required in patients with CD4 count < 200 cells/mm3:

Aerosolized pentamidine, trimethoprim/sulfamethoxazole, or dapsone as PCP prophylaxis.

Patients must have:

  • HIV infection.
  • Cutaneous Kaposi's sarcoma.
  • Life expectancy of at least 3 months.
  • Consent of parent or guardian if under 18 years of age.

NOTE:

  • This protocol is considered suitable for prison populations.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Peripheral neuropathy (grade 2 or worse).
  • Underlying severe or life-threatening infection with bacterial, viral, fungal, or protozoal pathogens.
  • Known hypersensitivity to TNP-470, fumagillin, or known related compounds.

PER AMENDMENT 9/3/96:

  • Cataracts.

Concurrent Medication:

Excluded:

  • Combination therapy with ddI/ddC (although these drugs may be administered alone or in combination with AZT).
  • Anticonvulsive medication.
  • Steroids.
  • Antineoplastic drugs.
  • Interferons.
  • Systemic or topical anti-Kaposi's sarcoma agents or regimens.
  • Suramin.
  • Aspirin.
  • Warfarin.
  • Heparin (including heparin flushes).
  • Nonsteroidal anti-inflammatory drugs.
  • Investigational status drugs.

Patients with the following prior conditions are excluded:

  • History of substantial non-iatrogenic bleeding disorders.
  • History of tumor or malignancies other than Kaposi's sarcoma, with the exception of completely resected basal cell skin carcinoma or in situ cervical carcinoma.
  • History of seizures within the past 10 years.

PER AMENDMENT 9/3/96:

  • History of cataracts.

Prior Medication:

Excluded within 4 weeks prior to study entry:

  • Steroids.
  • Antineoplastic drugs.
  • Interferons.
  • Systemic or topical anti-Kaposi's sarcoma agents or regimens.

Excluded within 6 months prior to study entry:

  • Suramin.

Unwilling to refrain from unprotected sexual contact or other activities that may result in HIV re-infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Dezube B

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

February 1, 1997

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 215
  • 11192 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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