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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Institutes of Health (NIH) |
Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00358319 |
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 Valproci 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.
Condition | Intervention | Phase |
Malignant Melanoma |
Drug: Karenitecin Drug: valproic acid (VPA) |
Phase I Phase II |
MedlinePlus related topics: | Cancer Melanoma |
Drug Information available for: | Divalproex sodium Valproate Sodium Valproic acid Karenitecin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Valproic Acid and Karenitecin for Metastatic Malignant Melanoma |
Estimated Enrollment: | 45 |
Study Start Date: | March 2005 |
This is a Phase I study evaluating the combination of Valproic Acid (VPA) and Karenitecin to treat patients with metastatic malignant melanoma. Treatment cycles are every 3 weeks and there are 17 study visits in all.
During Phase I subjects will receive one cycle of Karenitecin alone (cycle 1 days 1-5) and then combination therapy with VPA + Karenitecin (cycle 2 days 1-7)followed by oral VPA in divided doses for 5 days and Karenitecin starting the third day (days 3-7) every 3 weeks. After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the disease.
Dose escalations will continue until unacceptable dose limiting toxicity (DLT) occurs, then dose escalation will be stopped and the previous dose level will be explored. In each dose level, participants will undergo pharmacokinetic (PK) sampling to determine blood levels. The melanoma skin lesions will also be biopsied to measure the effect of the combination therapy.
All patients enrolled in the Phase II will be treated with VPA and Karenitecin using the dosing schedule determined to be the MTD in Phase I. In the absence of disease progression and if there is continued safety and tolerability, treatment may continue in consecutive 3 week cycles.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Same for Phase I & II
Exclusion Criteria:
Phase I:
Phase II:
Contact: Sem Bastien, RN | 813-745-3596 | SEM.BASTIEN@MOFFITT.ORG |
Contact: Adil Daud, MD | 813-745-8581 | DAUDAI@moffitt.usf.edu |
United States, Florida | |||||
H. Lee Moffitt Cancer Center & Research Institute | Recruiting | ||||
Tampa, Florida, United States, 33612 | |||||
Principal Investigator: Daniel Sullivan, M.D. | |||||
Principal Investigator: PAMELA MUNSTER, M.D. | |||||
Sub-Investigator: BARBARA CENTENO, M.D. | |||||
Sub-Investigator: Ronald DeConti, M.D. | |||||
Sub-Investigator: Vernon Sondak, M.D. | |||||
Sub-Investigator: Patricia Thompson, M.D. | |||||
Sub-Investigator: Michelle Mintz, ARNP | |||||
Sub-Investigator: Patrick Stauffer, PA-C |
H. Lee Moffitt Cancer Center and Research Institute |
National Institutes of Health (NIH) |
Principal Investigator: | Adil I Daud, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Moffiitt Cancer Center Clinical Trials Website 
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Study ID Numbers: | MCC-13991 |
First Received: | July 27, 2006 |
Last Updated: | April 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00358319 |
Health Authority: | United States: Food and Drug Administration |
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