search
Back to results

Metronomic Therapy in Patients With Metastatic Melanoma

Primary Purpose

Metastatic Melanoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vinblastine
Cyclophosphamide
dacarbazine
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring Metronomic Therapy, Metastatic Melanoma, Vinblastine, Cyclophosphamide, Dacarbazine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined Low Dose Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 17, 2012
Last Updated
December 26, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01542255
Brief Title
Metronomic Therapy in Patients With Metastatic Melanoma
Official Title
Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Low accrual not allowing to support statistical endpoints
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Metronomic Therapy, Metastatic Melanoma, Vinblastine, Cyclophosphamide, Dacarbazine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined Low Dose Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
vinblastine
Other Intervention Name(s)
Velban
Intervention Description
1 mg/m2 vinblastine given three times per week administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
Intervention Type
Drug
Intervention Name(s)
dacarbazine
Other Intervention Name(s)
DTIC
Intervention Description
15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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 Outcome Measure Information:
Title
Clinical Response Rate
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc S. Ernstoff, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Metronomic Therapy in Patients With Metastatic Melanoma

We'll reach out to this number within 24 hrs