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Metronomic Therapy in Patients With Metastatic Melanoma

This study has been terminated.
(Low accrual not allowing to support statistical endpoints)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542255
First Posted: March 2, 2012
Last Update Posted: September 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center
  Purpose

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.


Condition Intervention Phase
Metastatic Melanoma Drug: vinblastine Drug: Cyclophosphamide Drug: dacarbazine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine

Resource links provided by NLM:


Further study details as provided by Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Progression Free Survival [ 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 ]
    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.


Secondary Outcome Measures:
  • Clinical Response Rate [ 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. ]
    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


Enrollment: 7
Study Start Date: June 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Drug: vinblastine
1 mg/m2 vinblastine given three times per week administered intravenously.
Other Name: Velban
Drug: Cyclophosphamide
60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
Other Name: Cytoxan
Drug: dacarbazine
15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest
Other Name: DTIC

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542255


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Marc S. Ernstoff, MD Dartmouth-Hitchcock Medical Center
  More Information

Additional Information:
Responsible Party: Marc S. Ernstoff, Associate Director for Clinical Research, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01542255     History of Changes
Other Study ID Numbers: D1010
22362 ( Other Identifier: Committee for the Protection of Human Subjects )
First Submitted: January 17, 2012
First Posted: March 2, 2012
Results First Submitted: August 28, 2014
Results First Posted: September 9, 2014
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center:
Metronomic Therapy
Metastatic Melanoma
Vinblastine
Cyclophosphamide
Dacarbazine

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cyclophosphamide
Vinblastine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators