Melanoma Metastatic
Conditions
Keywords
Melanoma Metastatic
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.
Interventions
DRUGDacarbazine
Dacarbazine IV - Day 1
DRUGCarmustine
Carmustine IV- Day 2
DRUGNeulasta
Neulasta SC - Day 3
Sponsors
Western Regional Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 8 weeks | Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 8 weeks | To determine the response rate after being treated with Dacarbazine Carmustine |
| Median Duration of Response | 8 weeks | To determine the median duration of response for patients who received Dacarbazine and Carmustine |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Received Treatment Dacarbazine Carmustine participants | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Received Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Progression Free Survival
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
Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.
Secondary
Median Duration of Response
To determine the median duration of response for patients who received Dacarbazine and Carmustine
Time frame: 8 weeks
Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.
Secondary
Response Rate
To determine the response rate after being treated with Dacarbazine Carmustine
Time frame: 8 weeks
Population: Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.