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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.
 
ClinicalTrials.gov Identifier: NCT01692691
Recruitment Status : Terminated (PI decision)
First Posted : September 25, 2012
Results First Posted : February 2, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

Tracking Information
First Submitted Date  ICMJE August 29, 2012
First Posted Date  ICMJE September 25, 2012
Results First Submitted Date  ICMJE January 1, 2016
Results First Posted Date  ICMJE February 2, 2016
Last Update Posted Date April 4, 2018
Study Start Date  ICMJE August 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2012)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dacarbazine and Carmustine in Metastatic Melanoma
Official Title  ICMJE Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma Metastatic
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Dacarbazine, carmustine, neulasta
Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
Interventions:
  • Drug: Dacarbazine
  • Drug: Carmustine
  • Drug: Neulasta
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 1, 2015)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2012)
35
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01692691
Other Study ID Numbers  ICMJE 12-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Western Regional Medical Center
Study Sponsor  ICMJE Western Regional Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jordan Waypa, FNP CTCA
PRS Account Western Regional Medical Center
Verification Date March 2018

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