Metronomic Therapy in Patients With Metastatic Melanoma

NCT ID: NCT01542255

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-01-31

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.

Conditions

Metastatic Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

vinblastine

Intervention Type: DRUG

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

Cyclophosphamide

Intervention Type: DRUG

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

dacarbazine

Intervention Type: DRUG

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

Interventions

vinblastine

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

Intervention Type: DRUG

Cyclophosphamide

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

Intervention Type: DRUG

dacarbazine

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

Intervention Type: DRUG

Other Intervention Names

Velban; Cytoxan; DTIC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc S. Ernstoff, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

22362

Identifier Type: OTHER

Identifier Source: secondary_id

D1010

Identifier Type: -

Identifier Source: org_study_id