NCT00002342

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Sarcoma, KaposiHIV Infections

Keywords

NeoplasmsSarcoma, KaposiAcquired Immunodeficiency SyndromeAntineoplastic Agentstecogalan

Interventions

Tecogalan sodiumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mem Sloan - Kettering Cancer Ctr

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Sarcoma, KaposiHIV InfectionsNeoplasmsAcquired Immunodeficiency Syndrome

Interventions

tecogalan

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Vascular TissueBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-04

Locations

US(1)