Search / Trial NCT00000763

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

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

Trial Information

Current as of December 14, 2024

Completed

Keywords

Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents

ClinConnect Summary

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 patient...

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Gill PS

Study Chair

Dezube B

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Los Angeles, California, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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