Metronomic Therapy in Patients With Metastatic Melanoma

Phase 2TerminatedNCT01542255

Dartmouth-Hitchcock Medical Center7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Melanoma

Interventions

vinblastineDRUG

1 mg/m2 vinblastine given three times per week administered intravenously.

CyclophosphamideDRUG

60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest

dacarbazineDRUG

15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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.

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

Progression Free Survival

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.

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

Secondary Outcomes

Clinical Response Rate

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

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.

Data from ClinicalTrials.gov

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