A Study of Tecogalan Sodium
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ClinicalTrials.gov Identifier: NCT00002342 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections | Drug: Tecogalan sodium | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Twice Weekly for 21 Days |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002342
United States, New York | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 |
ClinicalTrials.gov Identifier: | NCT00002342 History of Changes |
Other Study ID Numbers: |
088C 4152A-PRT004 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | April 1996 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Neoplasms Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents tecogalan |
Additional relevant MeSH terms:
HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue |