Metronomic Therapy in Patients With Metastatic Melanoma
|ClinicalTrials.gov Identifier: NCT01542255|
Recruitment Status : Terminated (Low accrual not allowing to support statistical endpoints)
First Posted : March 2, 2012
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: vinblastine Drug: Cyclophosphamide Drug: dacarbazine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
U.S. FDA Resources
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
- 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 ]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. ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|