Metronomic Therapy in Patients With Metastatic Melanoma
SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine.
Patients with measurable metastatic melanoma are eligible. All patients will be treated as outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be treated continuously, until evidence of progression of disease, or for up to two cycles following disappearance of all disease. A cycle will be defined as three weeks of continuous therapy with a one week rest.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine|
- Progression Free Survival [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ] [ Designated as safety issue: No ]Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria.
- Clinical Response Rate [ Time Frame: Tumor evaluation will be performed every 8 weeks from day1 of cycle 1 (+ 1 week) while on therapy, clinical response will be assessed no less than 4 weeks after response criteria met. ] [ Designated as safety issue: No ]To be assigned a status of partial response or complete response, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of stable disease, follow-up measurements must have met the stable disease criteria at least once after study entry at a minimum interval (in general, not less than 6-8 weeks) that is defined in the study protocol
|Study Start Date:||June 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Combined Low Dose Treatment
A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.
Schema of treatment is:
1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv
1 mg/m2 vinblastine given three times per week administered intravenously.
Other Name: VelbanDrug: Cyclophosphamide
60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
Other Name: CytoxanDrug: dacarbazine
15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest
Other Name: DTIC
Low dose continuous chemotherapy, called metronomic chemotherapy, is designed to target vascular cells and inhibit tumor growth and metastasises. A recent study in a melanoma mouse model has identified low dose vinblastine, cyclophosphamide and dacarbazine as a treatment which improves the animal's survival and is superior to full dose dacarbazine alone. This clinical trial seeks to translate this laboratory model directly into metastatic melanoma patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542255
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Marc S. Ernstoff, MD||Dartmouth-Hitchcock Medical Center|