Stage IV Melanoma Clinical Trial
Official title:
Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make
the body build an immune response that will kill tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or
without immunotherapy in treating patients who have stage III or stage IV melanoma.
OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression
by at least 2 months with no decrease in the rate of objective clinical response OR an
improvement by at least 15% in the rate of objective clinical response with no decrease in
the median time to disease progression in patients with stage III or IV melanoma receiving
dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.
II. Determine the benefits, risks, and side effects of these regimens in this patient
population.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according
to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are
randomized to one of two treatment arms.
Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive
treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.
Patients with stable or responding disease may receive additional courses every 28 days.
Patients are followed every 4 months.
PROJECTED ACCRUAL:
A total of 280 patients (140 in each arm) will be accrued for this study.
;
Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02107755 -
Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Withdrawn |
NCT01216787 -
RO4929097 in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma That Can Be Removed by Surgery
|
Phase 2 | |
| Active, not recruiting |
NCT01026324 -
Dinaciclib in Treating Patients With Stage III-IV Melanoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01010984 -
LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma
|
N/A | |
| Completed |
NCT00553306 -
Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00121225 -
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
|
Phase 2 | |
| Completed |
NCT00019448 -
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Active, not recruiting |
NCT03200847 -
Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03235245 -
Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib
|
Phase 2 | |
| Terminated |
NCT01875653 -
Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
|
Phase 3 | |
| Completed |
NCT01748747 -
Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery
|
Early Phase 1 | |
| Terminated |
NCT01316692 -
Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma
|
Phase 2 | |
| Active, not recruiting |
NCT01120275 -
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
| Terminated |
NCT01166126 -
Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV
|
Phase 2 | |
| Terminated |
NCT01217411 -
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
|
Phase 1 | |
| Terminated |
NCT01026051 -
Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma
|
Phase 2 | |
| Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
| Completed |
NCT00288041 -
Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT00074308 -
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
|
Phase 1/Phase 2 | |
| Completed |
NCT00072163 -
Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
|
Phase 2 |