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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.

Sponsored by: Daiichi Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002138
  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 I

MedlinePlus related topics:   AIDS    Cancer    Kaposi's Sarcoma    Soft Tissue Sarcoma   

Drug Information available for:   Tecogalan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison, Safety Study
Official Title:   A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002138

Locations
United States, California
Univ of California at San Francisco Gen Hosp    
      San Francisco, California, United States, 94110

Sponsors and Collaborators
Daiichi Pharmaceuticals
  More Information


Study ID Numbers:   088D, 4152A-PRT005
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002138
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  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Neoplasms by Histologic Type
Slow Virus Diseases
Immune System Diseases
Neoplasms, Vascular Tissue
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on November 20, 2008




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