Dacarbazine and Carmustine in Metastatic Melanoma
Primary Purpose
Melanoma Metastatic
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dacarbazine
Carmustine
Neulasta
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma Metastatic focused on measuring Melanoma Metastatic
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Western Regional Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dacarbazine, carmustine, neulasta
Arm Description
Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
Outcomes
Primary Outcome Measures
Progression Free Survival
Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy
Secondary Outcome Measures
Response Rate
To determine the response rate after being treated with Dacarbazine Carmustine
Median Duration of Response
To determine the median duration of response for patients who received Dacarbazine and Carmustine
Full Information
NCT ID
NCT01692691
First Posted
August 29, 2012
Last Updated
March 8, 2018
Sponsor
Western Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01692691
Brief Title
Dacarbazine and Carmustine in Metastatic Melanoma
Official Title
Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
PI decision
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Regional Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma Metastatic
Keywords
Melanoma Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dacarbazine, carmustine, neulasta
Arm Type
Experimental
Arm Description
Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Other Intervention Name(s)
DTIC
Intervention Description
Dacarbazine IV - Day 1
Intervention Type
Drug
Intervention Name(s)
Carmustine
Other Intervention Name(s)
BCNU
Intervention Description
Carmustine IV- Day 2
Intervention Type
Drug
Intervention Name(s)
Neulasta
Other Intervention Name(s)
pegfilgrastim
Intervention Description
Neulasta SC - Day 3
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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
Secondary Outcome Measure Information:
Title
Response Rate
Description
To determine the response rate after being treated with Dacarbazine Carmustine
Time Frame
8 weeks
Title
Median Duration of Response
Description
To determine the median duration of response for patients who received Dacarbazine and Carmustine
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Waypa, FNP
Organizational Affiliation
CTCA
Official's Role
Study Director
Facility Information:
Facility Name
Western Regional Medical Center
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dacarbazine and Carmustine in Metastatic Melanoma
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