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NCT00301067 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma
A Phase 1 study of Metastatic Melanoma, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00301067: Completed Phase 1 study of Metastatic Melanoma, sponsored by Northwestern University.
NCT00301067 is a Phase 1 study of Metastatic Melanoma that has completed, run by Northwestern University. The registered enrollment target is 20 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00301067, a Phase 1 study of Metastatic Melanoma, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor. PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of calcitriol when given together with temozolomide, and to see how well they work in treating patients with metastatic stage IV melanoma.
Primary Outcome
Determine number and frequency of dose limiting toxicities (DLT) of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma for up to 12 cycles of therapy, where 1 cycle equals 28 days. 3 patients per dose cohort will be entered into the trial at doses of 0.2, 0.3, and 0.5 mcg/kg of calcitriol administered orally. If 1 patient experiences dose limiting toxicity (DLT) at any dose, that dose cohort will be expanded to a maximum of 6 patients. If 1 additional
Conditions Studied
Interventions
- DRUG Temozolomide
- DIETARY_SUPPLEMENT Calcitriol
Study Locations (1)
Illinois
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-01-30 |
| Est. Completion | 2012-07-09 |
| Phase | Phase 1 |
What the finished NCT00301067 record still lists
NCT00301067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide is the first listed.
NCT00301067 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT00301067 about?
NCT00301067 is a clinical study titled "Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma". RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug. Calcitriol may also ...
What is the current status of trial NCT00301067?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2005-01-30. Estimated completion is 2012-07-09.
What conditions does trial NCT00301067 study?
This clinical trial studies the following conditions: Metastatic Melanoma.
What interventions are being tested in trial NCT00301067?
The interventions under investigation include: Temozolomide (DRUG), Calcitriol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00301067?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00301067 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00301067's enrollment target sits among peer trials
20 64th of 91 higher than 24 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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