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A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days


Phase 1
18 Years
N/A
Not Enrolling
Both
Sarcoma, Kaposi, HIV Infections

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Trial Information

A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days


Patients receive intravenous DS-4152 by infusion once every 21 days; 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:

Excluded:

- 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:

Excluded:

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

- Investigational agents within the past 4 weeks.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

088A

NCT ID:

NCT00002136

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

Name

Location

Cancer Therapy Research Ctr San Antonio, Texas  78229