A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
12 Years
N/A
Both
Sarcoma, Kaposi, HIV Infections
Trial Information
A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
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.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
Principal Investigator
Gill PS
Investigator Role:
Study Chair
Authority:
United States: Federal Government
Study ID:
ACTG 215
NCT ID:
NCT00000763
Start Date:
Completion Date:
February 1997
Related Keywords:
- Sarcoma, Kaposi
- HIV Infections
- Sarcoma, Kaposi
- Acquired Immunodeficiency Syndrome
- Antineoplastic Agents
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Sarcoma, Kaposi
- AIDS-Related Opportunistic Infections
- Sarcoma
Name | Location |
|---|---|
| USC CRS | Los Angeles, California 90033 |
| Northwestern University CRS | Chicago, Illinois 60611 |
| Beth Israel Deaconess - East Campus A0102 CRS | Boston, Massachusetts 02215 |
| Bmc Actg Crs | Boston, Massachusetts 02118 |
| Washington U CRS | St. Louis, Missouri |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York, New York 10003 |
