To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152)
and to establish the MTD at each of the different dosing schedules.
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.
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.
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
- 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.
- 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.
- Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).
- Investigational agents within the past 4 weeks.