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

This study has been completed.
Study NCT00002138.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.
Official Title  A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.
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.

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Dose Comparison, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Sarcoma, Kaposi
HIV Infections
Intervention  Drug: Tecogalan sodium
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002138
Organization ID 088D
Secondary IDs †† 4152A-PRT005
Study Sponsor  Daiichi Pharmaceuticals
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date April 1996
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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