Metronomic Therapy in Patients With Metastatic Melanoma
| Status: | Terminated |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | June 2010 |
| End Date: | January 2013 |
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.
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.
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.
- 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.
We found this trial at
1
site
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
Click here to add this to my saved trials
