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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:
Information provided by (Responsible Party):
Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01542255
First received: January 17, 2012
Last updated: September 8, 2014
Last verified: September 2014

January 17, 2012
September 8, 2014
June 2010
January 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy.
Complete list of historical versions of study NCT01542255 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Metronomic Therapy in Patients With Metastatic Melanoma
Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Melanoma
  • 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
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

Interventions:
  • Drug: vinblastine
  • Drug: Cyclophosphamide
  • Drug: dacarbazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
January 2013
January 2013   (final data collection date for primary outcome measure)
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01542255
D1010, 22362
Yes
Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Not Provided
Principal Investigator: Marc S. Ernstoff, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP