A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
NCT ID: NCT00000763
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
1997-02-28
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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TNP-470
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Gill PS
Role: STUDY_CHAIR
Dezube B
Role: STUDY_CHAIR
Locations
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USC CRS
Los Angeles, California, United States
Northwestern University CRS
Chicago, Illinois, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
Countries
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References
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Dezube BJ, Von Roenn JH, Holden-Wiltse J, Cheung TW, Remick SC, Cooley TP, Moore J, Sommadossi JP, Shriver SL, Suckow CW, Gill PS. Fumagillin analog in the treatment of Kaposi's sarcoma: a phase I AIDS Clinical Trial Group study. AIDS Clinical Trial Group No. 215 Team. J Clin Oncol. 1998 Apr;16(4):1444-9. doi: 10.1200/JCO.1998.16.4.1444.
Frenkel LM, Wagner LE 2nd, Atwood SM, Cummins TJ, Dewhurst S. Specific, sensitive, and rapid assay for human immunodeficiency virus type 1 pol mutations associated with resistance to zidovudine and didanosine. J Clin Microbiol. 1995 Feb;33(2):342-7. doi: 10.1128/jcm.33.2.342-347.1995.
Pluda JM, Wyvill K, Lietzau J, Figg D, Saville MW, Nguyen BY, Foli A, Bailey J, Cooper M. A phase I trial of TNP-470 (AGM-1470) administered to patients with HIV-associated kaposi's sarcoma (KS). Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:61
Other Identifiers
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11192
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 215
Identifier Type: -
Identifier Source: org_study_id