Malignant Melanoma Clinical Trial
Official title:
Phase I/II Trial of Valproic Acid and Karenitecin for Metastatic Malignant 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 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04229277 -
Fast Track Diagnosis of Skin Cancer by Advanced Imaging
|
N/A | |
| Completed |
NCT03653819 -
High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs
|
N/A | |
| Active, not recruiting |
NCT04074096 -
Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis
|
Phase 2 | |
| Completed |
NCT02935790 -
Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab
|
Phase 1 | |
| Recruiting |
NCT05478876 -
Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract
|
N/A | |
| Completed |
NCT01211262 -
Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma
|
Phase 1 | |
| Recruiting |
NCT03649529 -
Treatment of Malignant Melanoma With GPA-TriMAR-T Cell Therapy
|
Early Phase 1 | |
| Completed |
NCT03278665 -
4SC-202 in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy
|
Phase 1/Phase 2 | |
| Completed |
NCT04452214 -
A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
|
Phase 1 | |
| Terminated |
NCT02709889 -
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01455259 -
Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT00978913 -
Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma
|
Phase 1 | |
| Completed |
NCT00232726 -
Clinical Study of Previously Untreated Patients With Malignant Melanoma
|
Phase 2 | |
| Completed |
NCT00350597 -
GM-CSF as Adjuvant Therapy of Melanoma
|
Phase 2 | |
| Completed |
NCT00336986 -
Efficacy Study of IL-21 to Treat Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT02523313 -
Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED
|
Phase 2 | |
| Completed |
NCT03545334 -
Lymph Node Identification in Skin Malignancy Using ICG Transcutaneously Study
|
N/A | |
| Completed |
NCT04253574 -
Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
|
||
| Completed |
NCT00179608 -
Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy
|
Phase 1 | |
| Terminated |
NCT00104884 -
FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
|
Phase 2 |