Dacarbazine and Carmustine in Metastatic Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01692691
First received: August 29, 2012
Last updated: January 9, 2014
Last verified: January 2014

August 29, 2012
January 9, 2014
August 2012
December 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01692691 on ClinicalTrials.gov Archive Site
  • response rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • median duration of response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • median survival of patients treated with combination. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Interventions:
  • Drug: Dacarbazine
  • Drug: Carmustine
  • Drug: Neulasta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
December 2015
December 2015   (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
Both
18 Years and older
No
Contact: Marci Pierog, RN 623-207-3818 marci-pierog@ctca-hope.com
Contact: India L Hill 623-207-3392 india.hill@ctca-hope.com
United States
 
NCT01692691
12-10
No
Walter Quan Jr., MD, Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Walter Quan, MD Western Regional Medical Center
Western Regional Medical Center
January 2014

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