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

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.