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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002138
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sarcoma, Kaposi

Keywords

Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, tecogalan

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.

Interventions

DRUGTecogalan sodium

Sponsors

Daiichi Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026