Metastatic Melanoma Clinical Trial
Official title:
Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine
NCT number | NCT01542255 |
Other study ID # | D1010 |
Secondary ID | 22362 |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2010 |
Est. completion date | January 2013 |
Verified date | September 2014 |
Source | Dartmouth-Hitchcock Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | 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 | 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. |
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