NCT01542255

Metronomic Therapy in Patients With Metastatic Melanoma

Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	vinblastine	1 mg/m2 vinblastine given three times per week administered intravenously.
DRUG	Cyclophosphamide	60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
DRUG	dacarbazine	15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-03-02
• Last updated: 2019-01-15
• Results posted: 2014-09-09

Locations

1 site across 1 country: United States