Clinical trial NCT01692691: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma Metastatic
Keywords: Melanoma Metastatic
Lead sponsor: Western Regional Medical Center
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 8 weeks
Secondary outcomes:
measure: Response Rate
timeFrame: 8 weeks
measure: Median Duration of Response
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Western Regional Medical Center
state: Arizona
Study officials:
affiliation: CTCA
name: Jordan Waypa, FNP
role: STUDY_DIRECTOR
References: