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NCT00082017 · ClinicalTrials.gov registry record · Phase 2
UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00082017: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00082017 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00082017, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study will examine the effects of an experimental drug called UCN-01 (7-hydroxystaurosporine) on T-cell lymphomas. UCN-01 inhibits the growth of several different tumor cells, and, in laboratory studies, it has worked particularly well on tumor cells taken from patients with T cell lymphomas. Patients 9 years of age and older with T cell lymphoma that has relapsed or is not responding to chemotherapy may be eligible for this study. Candidates will be screened with a medical histories and physical examinations, blood and urine tests, electrocardiograms, chest x-rays, and computed tomography (CT) scans of the chest, abdomen and pelvis. Additional tests may be done if clinically indicated, such as positron emission tomography (PET) scans, bone marrow aspirations and biopsies, lumbar punctures (spinal taps) and CT's or magnetic resonance imaging (MRI) scans if there is evidence of central nervous system disease. Participants are given UCN-01 in 28-day treatment cycles. The drug is given by vein in a continuous 72-hour infusion on the first cycle and in 36-hour infusions on subsequent cycles. The total number of cycles patients receive depends on how well the tumor responds to the drug and how well the patient tolerates drug side effects. Patients who do well may receive treatment for up to 1 year. Patients whose disease worsens with treatment or who do not tolerate the therapy are taken off the study. Some or all of the screening tests are repeated periodically during the course of treatment to monitor safety and treatment response. X-rays and scans are done every other treatment cycle for the first 6 cycles and then, if the cancer is stable or improving, the interval between these imaging studies is lengthened to every 4 cycles. Patients whose tumors can be safely biopsied undergo this procedure before entering the study and 3 to 5 days after completing the first UCN-01 treatment. Biopsies requiring open surgery (e.g., in the chest or abdomen) are done only if
Interventions
- DRUG UCN-01 (7-hydroxystaurosporine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2004-04-05 |
| Est. Completion | 2011-09-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00082017
The ClinicalTrials.gov registry entry for NCT00082017 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which UCN-01 (7-hydroxystaurosporine) is the first listed.
NCT00082017 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00082017 about?
NCT00082017 is a clinical study titled "UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas". This study will examine the effects of an experimental drug called UCN-01 (7-hydroxystaurosporine) on T-cell lymphomas. UCN-01 inhibits the growth of several different tumor cells, and, in laboratory studies, it has worked particularly well on tumor cells taken from patients with T cell lymphomas. ...
What is the current status of trial NCT00082017?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2004-04-05. Estimated completion is 2011-09-27.
What interventions are being tested in trial NCT00082017?
The interventions under investigation include: UCN-01 (7-hydroxystaurosporine) (DRUG).
Who is sponsoring clinical trial NCT00082017?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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