Dacarbazine and Carmustine in Metastatic Melanoma

Study Overview
=================
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.

Official Title
-----------------
Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma

Conditions
-----------------
Melanoma Metastatic

Intervention / Treatment
-----------------
* Drug: Dacarbazine
* Drug: Carmustine
* Drug: Neulasta


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dacarbazine, carmustine, neulasta<br>Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3 | Drug: Dacarbazine<br>* Dacarbazine IV - Day 1<br>* Other names: DTIC;Drug: Carmustine<br>* Carmustine IV- Day 2<br>* Other names: BCNU;Drug: Neulasta<br>* Neulasta SC - Day 3<br>* Other names: pegfilgrastim;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | To determine the response rate after being treated with Dacarbazine Carmustine | 8 weeks | 
| Median Duration of Response | To determine the median duration of response for patients who received Dacarbazine and Carmustine | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma Metastatic