A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Pharmaceuticals

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.