Conditions: Metastatic Melanoma
Keywords: Metronomic Therapy Metastatic Melanoma Vinblastine Cyclophosphamide Dacarbazine
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 7
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 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

Interventions: intervention 1: vinblastine intervention 2: Cyclophosphamide intervention 3: dacarbazine
Intervention descriptions: intervention 1: 1 mg/m2 vinblastine given three times per week administered intravenously. intervention 2: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest intervention 3: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest

Protocol document: