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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sarcoma, Kaposi HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Tecogalan sodium

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Univ of California at San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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4152A-PRT005

Identifier Type: -

Identifier Source: secondary_id

088D