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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002136
• Other study ID #: 088A
• Secondary ID: 4152A-PRT001
• 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 once every 21 days; 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	Cancer Therapy Research Ctr	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Eckhardt SG, et al. Results of a phase I trial of the novel angiogenesis inhibitor, tecogalan sodium (meeting abstract). Proc Annu Meet Am Assoc Cancer Res. 1995; 36:A628