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

Sponsor

Daiichi Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00002138

Collaborator

(none)

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: Tecogalan sodium	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.