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NCT00358319 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial of Valproic Acid and Karenitecin for Melanoma
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00358319 is a Phase 1 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 42 participants.
The verdict
NCT00358319, a Phase 1 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a Phase I study looking at the combination of Valproic Acid (VPA) and Karenitecin to treat patients with metastatic malignant melanoma. We will find the dose-limiting toxicity (DLT) and the highest dose (maximum tolerated dose) of this combination treatment that has acceptable side effects and recommend a Phase II dose level. There will be seven escalating doses of Valproic acid and one dose escalation step of Karenitecin. Each patient shall receive one cycle of Karenitecin alone (cycle 1 days 1 - 5) followed by the same dose of Karenitecin given in combination with VPA (cycle 2 days 1-7). Patients will receive oral VPA in divided doses for 5 days and Karenitecin starting on the 3rd day every 3 weeks (a treatment cycle). Treatment will continue until progression of disease or an unacceptable level of toxicity. After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the disease. In the absence of disease progression and if there is continued safety and tolerability, treatment may continue.
Interventions
- DRUG Valproic Acid
- DRUG Karenitecin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2005-03 |
| Est. Completion | 2007-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00358319
The ClinicalTrials.gov registry entry for NCT00358319 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Valproic Acid is the first listed.
NCT00358319 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00358319 about?
NCT00358319 is a clinical study titled "Phase I/II Trial of Valproic Acid and Karenitecin for Melanoma". This is a Phase I study looking at the combination of Valproic Acid (VPA) and Karenitecin to treat patients with metastatic malignant melanoma. We will find the dose-limiting toxicity (DLT) and the highest dose (maximum tolerated dose) of this combination treatment that has acceptable side effects a...
What is the current status of trial NCT00358319?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2005-03. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00358319?
The interventions under investigation include: Valproic Acid (DRUG), Karenitecin (DRUG).
Who is sponsoring clinical trial NCT00358319?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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