Dacarbazine and Carmustine in Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01692691
Recruitment Status : Terminated (PI decision)
First Posted : September 25, 2012
Results First Posted : February 2, 2016
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
Western Regional Medical Center

August 29, 2012
September 25, 2012
January 1, 2016
February 2, 2016
April 4, 2018
August 2012
October 2014   (Final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 8 weeks ]
Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy
Progression Free Survival of Patients With Stage IV Melanoma Who Have Had Disease Progression on at Least One Prior Systemic Therapy [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT01692691 on Archive Site
  • Response Rate [ Time Frame: 8 weeks ]
    To determine the response rate after being treated with Dacarbazine Carmustine
  • Median Duration of Response [ Time Frame: 8 weeks ]
    To determine the median duration of response for patients who received Dacarbazine and Carmustine
  • Response Rate [ Time Frame: 8 weeks ]
  • Median Duration of Response [ Time Frame: 8 weeks ]
  • Median Survival of Patients Treated With Combination. [ Time Frame: 8 weeks ]
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Dacarbazine and Carmustine in Metastatic Melanoma
Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma
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.
In this phase II trial, patients with stage IV melanoma will be treated with dacarbazine and carmustine commonly used in this cancer, but given using a schedule that might theoretically improve on this combination. Patients on this study will be assessed in terms of toxicity, response rate, median duration of response, median time to disease progression, and median survival.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Melanoma Metastatic
  • Drug: Dacarbazine
    Dacarbazine IV - Day 1
    Other Name: DTIC
  • Drug: Carmustine
    Carmustine IV- Day 2
    Other Name: BCNU
  • Drug: Neulasta
    Neulasta SC - Day 3
    Other Name: pegfilgrastim
Experimental: Dacarbazine, carmustine, neulasta
Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
  • Drug: Dacarbazine
  • Drug: Carmustine
  • Drug: Neulasta
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2014
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Western Regional Medical Center
Western Regional Medical Center
Not Provided
Study Director: Jordan Waypa, FNP CTCA
Western Regional Medical Center
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP