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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TNP-470
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USC CRS
  • Northwestern University CRS
  • Bmc Actg Crs
  • Beth Israel Deaconess - East Campus A0102 CRS
  • Washington U CRS
  • Beth Israel Med. Ctr. (Mt. Sinai)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000763
Brief Title
A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
Official Title
A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TNP-470

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gill PS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dezube B
Official's Role
Study Chair
Facility Information:
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Bmc Actg Crs
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess - East Campus A0102 CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9552050
Citation
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.
Results Reference
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PubMed Identifier
7714190
Citation
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.
Results Reference
background
Citation
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
Results Reference
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A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma

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