A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4
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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.
Condition or disease
Sarcoma, KaposiHIV Infections
Drug: Tecogalan sodium
Patients receive intravenous DS-4152 by infusion weekly for 4 weeks, 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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 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.
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).
Tulpule A, Snyder JC, Espina BM, Higashi L, Satomi M, Lombardy EE. A phase I study of tecogalan, a novel angiogenesis inhibitor in the treatment of AIDS-related Kaposi's sarcoma and solid tumors (meeting abstract). Gill PS. Blood 1994;84(10, Suppl 1):248a
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
DNA Virus Infections
Neoplasms, Vascular Tissue