Know Cancer

forgot password

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

Phase 1
12 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

Thank you

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:


- 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.


- 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.


- Cataracts.

Concurrent Medication:


- 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.


- 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:


Study Design:

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Principal Investigator

Gill PS

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 215



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



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