Dacarbazine and Carmustine in Metastatic Melanoma

Melanoma Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01692691
• Other study ID #: 12-10
• Status: Terminated
• Phase: Phase 2
• First received: August 29, 2012
• Last updated: March 8, 2018
• Start date: August 2012
• Est. completion date: October 2014

Study information

• Verified date: March 2018
• Source: Western Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma Metastatic

Intervention

Drug:
• Dacarbazine
Dacarbazine IV - Day 1
• Carmustine
Carmustine IV- Day 2
• Neulasta
Neulasta SC - Day 3

Locations

Country	Name	City	State
United States	Western Regional Medical Center	Goodyear	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Western Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	8 weeks
Secondary	Response Rate	To determine the response rate after being treated with Dacarbazine Carmustine	8 weeks
Secondary	Median Duration of Response	To determine the median duration of response for patients who received Dacarbazine and Carmustine	8 weeks