A Study of Tecogalan Sodium

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002342
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  Purpose

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 Twice Weekly for 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 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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002342

Locations
United States, New York
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Sponsors and Collaborators
Daiichi Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002342     History of Changes
Other Study ID Numbers: 088C, 4152A-PRT004
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:
Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antineoplastic Agents
tecogalan

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014