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NCT00591370 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT00591370: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00591370 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00591370, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every day for 6 weeks at a time. Temozolomide given by this extended schedule is experimental, although we have found that it is safe and can shrink melanoma in some patients. One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it can be given daily over a long period of time rather than off and on like DTIC. We think that TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients. When extended dosing TMZ was given with either thalidomide or long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves. In this study, we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage. We also want to learn more about which tumors are more likely to shrink from TMZ treatment. We will test samples of your tumor for whether or not a gene called MGMT has been turned on,
Interventions
- DRUG Temozolomide (TMZ)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2005-01 |
| Est. Completion | 2008-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00591370
The ClinicalTrials.gov registry entry for NCT00591370 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Temozolomide (TMZ) is the first listed.
NCT00591370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00591370 about?
NCT00591370 is a clinical study titled "Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma". Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every d...
What is the current status of trial NCT00591370?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2005-01. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00591370?
The interventions under investigation include: Temozolomide (TMZ) (DRUG).
Who is sponsoring clinical trial NCT00591370?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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