A Study of Tecogalan Sodium

Launched by DAIICHI PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.