A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4
This study has been completed.
Sponsor:
Daiichi Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002137
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130228113916im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 Weekly x 4 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130228113916im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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.
![](https://webarchive.library.unt.edu/web/20130228113916im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130228113916im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
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
ClinicalTrials.gov Identifier: | NCT00002137 History of Changes |
Other Study ID Numbers: | 088B, 4152A-PRT002 |
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 February 26, 2013