Dacarbazine and Carmustine in Metastatic Melanoma
Stopped early · Phase 2
Conditions studied: Melanoma Metastatic
In brief
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.
Key facts
- Study ID
- NCT01692691
- Run by
- Western Regional Medical Center
- People needed
- 1
- Starts
- 2012-08-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2018-04-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have a histologically-proven diagnosis of metastatic malignant melanoma which has progressed on at least one prior systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and estimated survival of at least 3 months.
- Patients must be felt to have recovered from effects of prior cancer therapy, such as past expected leukocyte nadir for chemotherapy (> 2 weeks).
- 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.
- Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
- Patient consent must be obtained prior to entrance onto study.
- 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.
You may not qualify if…
- Evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina, or cerebrovascular accident.
- Prior history of psychiatric disorder that could be exacerbated by or which could preclude completion of this therapy.
- Pregnancy or lactation.
- Prior chemotherapy with carmustine
Where it is running
- Western Regional Medical Center — Goodyear, Arizona, United States
Full record on ClinicalTrials.gov
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