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A Phase I Trial of Tecogalan sodium ( DS-4152 ) Administered as an Infusion Weekly x 4



A Phase I Trial of Tecogalan sodium ( DS-4152 ) Administered as an Infusion Weekly x 4

For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Kenneth Norris Jr Cancer Ctr / USC
Los Angeles,  California,  90033
United States
 


Additional Information:
Study ID Numbers:  088B;  4152A-PRT002
Study Start Date: 
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002137

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5. A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 mg q 8 h Versus 1,200 mg q 12 h in Combination with Zidovudine and 3TC

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