Metastatic Melanoma Clinical Trial
Official title:
Phase Ib/II: Epigenetic Modification of Chemosensitivity and Apoptosis in Metastatic Melanoma: Treatment of a Resistant Disease Using Decitabine, Temozolomide and Panobinostat
The purpose of this study is to treat metastatic melanoma with a combination of standard
chemotherapy (decitabine and Temozolomide in a dose escalation scheme) with an study drug
called panobinostat. This combination is proposed to unlock genes that may contribute to
mechanisms that cause tumor growth.
The primary objectives of this study are:
- To evaluate the safety and tolerability of the proposed schedule of decitabine,
temozolomide and panobinostat in the treatment of metastatic melanoma.
- To define any Dose Limiting Toxicity (DLT) and maximum tolerated dose (MTD) of the
combination of decitabine, temozolomide and panobinostat.
Most chemotherapeutics target rapidly proliferating cells, leaving quiescent cells and those
with extended cell cycles unaffected. The investigators propose that this combination of
decitabine, temozolomide, and panobinostat will target both melanoma stem cells and rapidly
proliferating melanoma cells. The use of two drugs that regulate gene expression
epigenetically (panobinostat and decitabine) in combination with a chemotherapeutic agent
(temozolomide) is hypothesized to:
- induce expression genes (e.g., Apaf-1) that increase chemosensitivity of tumor cells
and enhance apoptosis
- potentiate the cytotoxic effect of temozolomide by epigenetic modulation, and
- induce proliferation and differentiation of tumor stem cells, thus enabling senescence
and apoptosis.
Secondary objectives:
- To measure overall survival
- To measure the time to progression of patients treated with this combination in
comparison to patients treated historically with DTIC (the current standard of care).
- To evaluate treatment response with FDG PET and compare FDG PET with conventional
imaging for treatment response assessment.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02224781 -
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
|
Phase 3 | |
| Active, not recruiting |
NCT05470283 -
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
|
Phase 1 | |
| Recruiting |
NCT05388877 -
E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma
|
Phase 1 | |
| Active, not recruiting |
NCT05103891 -
Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations
|
Phase 1 | |
| Completed |
NCT00414765 -
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma
|
Phase 4 | |
| Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT01621490 -
PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma
|
Phase 1 | |
| Recruiting |
NCT05779423 -
Cryoablation+Ipilimumab+Nivolumab in Melanoma
|
Phase 2 | |
| Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT02278887 -
Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma
|
Phase 3 | |
| Active, not recruiting |
NCT02360579 -
Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
|
Phase 2 | |
| Terminated |
NCT02521870 -
A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02177110 -
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
|
||
| Withdrawn |
NCT01340729 -
Open-Label Study of TPI 287 for Patients With Metastatic Melanoma
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT01416844 -
Study of Immune Responses in Patients With Metastatic Melanoma
|
Phase 2 | |
| Terminated |
NCT01468818 -
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT00984464 -
Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT00631618 -
Clinical Trial of Sutent to Treat Metastatic Melanoma
|
Phase 2 | |
| Terminated |
NCT00571116 -
Disulfiram Plus Arsenic Trioxide In Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy
|
Phase 1 | |
| Recruiting |
NCT00226473 -
Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma
|
Phase 4 |