Melanoma Metastatic Clinical Trial
Official title:
Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma
Verified date | March 2018 |
Source | Western Regional Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether dacarbazine and carmustine at the doses and schedule used in this study will help to increase tumor shrinkage.
Status | Terminated |
Enrollment | 1 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients must have a histologically-proven diagnosis of metastatic malignant melanoma which has progressed on at least one prior systemic therapy. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and estimated survival of at least 3 months. 3. Patients must be felt to have recovered from effects of prior cancer therapy, such as past expected leukocyte nadir for chemotherapy (> 2 weeks). 4. Absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl; platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; ALT and AST must be less than 3 times the upper limit of normal; creatinine must be less than or equal to 1.8 mg/dl. 5. Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken. 6. Patient consent must be obtained prior to entrance onto study. 7. Patients must have no evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina or cerebrovascular accident. Exclusion Criteria: 1. Evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina, or cerebrovascular accident. 2. Prior history of psychiatric disorder that could be exacerbated by or which could preclude completion of this therapy. 3. Pregnancy or lactation. 4. Prior chemotherapy with carmustine |
Country | Name | City | State |
---|---|---|---|
United States | Western Regional Medical Center | Goodyear | Arizona |
Lead Sponsor | Collaborator |
---|---|
Western Regional Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy | 8 weeks | |
Secondary | Response Rate | To determine the response rate after being treated with Dacarbazine Carmustine | 8 weeks | |
Secondary | Median Duration of Response | To determine the median duration of response for patients who received Dacarbazine and Carmustine | 8 weeks |
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