A Study of Tecogalan Sodium

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002342
• Other study ID #: 088C
• Secondary ID: 4152A-PRT004
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma, Kaposi

Intervention

Drug:
• Tecogalan sodium

Locations

Country	Name	City	State
United States	Mem Sloan - Kettering Cancer Ctr	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Pharmaceuticals

Country where clinical trial is conducted

United States,