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Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.

Phase 2
18 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

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Trial Information

Phase II Evaluation of Oral ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma.

Patients receive open-label ALRT1057 for 16 weeks, as tolerated. In the absence of
unacceptable toxicity, patients may continue treatment indefinitely provided they continue
to benefit from therapy and the study remains open and active.

Thirteen patients are treated initially. If at least one response is observed in these
patients, up to 14 additional patients will be evaluated.

Inclusion Criteria

Inclusion Criteria

Patients must have:

- HIV positive status and histologic confirmation of KS.

- CD4 count > 200 mm3 (required of one-half of patients).

- Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting
criteria for "indicator" lesions.

- Acceptable organ system function.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Serious or intercurrent illness or infection that would interfere with the ability of the
patient to carry out the treatment program.

Prior Medication:


- Systemic therapy for KS within 30 days.

- Local or topical therapy for KS indicative lesions within 60 days.

- Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other
retinoid class drug.


Approved antiretroviral therapy.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Sarcoma, Kaposi
  • Antineoplastic Agents
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma