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A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.

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

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Trial Information

A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.

Patients receive intravenous DS-4152 by infusion twice weekly for 21 days, followed by 2
weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be
obtained from patients with Kaposi's sarcoma.

Inclusion Criteria

Inclusion Criteria

Patients must have:

- Kaposi's sarcoma plus HIV infection OR metastatic solid tumor.

- Life expectancy of at least 12 weeks.

- NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks.

- Recovered from toxicity of any prior anticancer therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Leukemia or lymphoma.

- Current gastrointestinal bleeding by stool guaiac.

- Extensive bone metastases or significant radiographic osteoporosis in patients with
solid tumors.

- Active heart disease such as uncontrolled angina, uncompensated congestive heart
failure, or dysrhythmias requiring antiarrhythmics.

- Acute intercurrent infection other than genital herpes.

- Symptomatic or known central nervous system involvement (including brain metastases)
unless stable and off therapy.

Concurrent Medication:


- Other anticancer therapy.

- Other investigational agents.

Patients with the following prior conditions are excluded:

- History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease.

- History of myocardial infarction within past 6 months.

Prior Medication:


- Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).

- Investigational agents within the past 4 weeks.

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
  • Neoplasms
  • Sarcoma, Kaposi
  • Acquired Immunodeficiency Syndrome
  • Antineoplastic Agents
  • tecogalan
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma



Univ of California at San Francisco Gen Hosp San Francisco, California  94110