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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000763
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012

November 2, 1999
March 30, 2012
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Complete list of historical versions of study NCT00000763 on ClinicalTrials.gov Archive Site
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A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: TNP-470
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 1997
Not Provided

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.

Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000763
ACTG 215, 11192
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Gill PS
Study Chair: Dezube B
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP