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A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tecogalan sodium
Sponsored by
Daiichi Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, tecogalan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kenneth Norris Jr Cancer Ctr / USC

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Daiichi Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00002137
Brief Title
A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4
Official Title
A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Pharmaceuticals

4. Oversight

5. Study Description

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 weekly for 4 weeks, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, tecogalan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tecogalan sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kenneth Norris Jr Cancer Ctr / USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Tulpule A, Snyder JC, Espina BM, Higashi L, Satomi M, Lombardy EE. A phase I study of tecogalan, a novel angiogenesis inhibitor in the treatment of AIDS-related Kaposi's sarcoma and solid tumors (meeting abstract). Gill PS. Blood 1994;84(10, Suppl 1):248a
Results Reference
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A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4

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