Metronomic Therapy in Patients With Metastatic Melanoma

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Cyclophosphamide; Dacarbazine; Vinblastine

Criteria

• Metastatic melanoma with measurable disease

• Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosoureas) and recovered from all ill

• Karnofsky Performance Status ≥60%

• Life expectancy ≥ twelve weeks

• Adequate end organ function

• Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study.

• Appropriate Contraception in both sexes

• The patient must be competent and signed informed consent.

EXCLUSION CRITERIA

• Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS.

• In patients with a prior history of invasive malignancy, less than five years in complete remission.

• Have evidence of significant co-morbid illness such as uncontrolled diabetes - Uncontrolled brain metastasis: Patients with brain metastasis most have been treated with brain radiation therapy or surgery and remain clinically stable for a minimum of 4 weeks.