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

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
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 Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Tecogalan sodium
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:


  • 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:


  • Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).
  • Investigational agents within the past 4 weeks.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002136

United States, Texas
Cancer Therapy Research Ctr
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Daiichi Pharmaceuticals
  More Information

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

ClinicalTrials.gov Identifier: NCT00002136     History of Changes
Other Study ID Numbers: 088A  4152A-PRT001 
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antineoplastic Agents

Additional relevant MeSH terms:
Sarcoma, Kaposi
DNA Virus Infections
Herpesviridae Infections
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
Virus Diseases

ClinicalTrials.gov processed this record on May 24, 2016