Dacarbazine and Carmustine in Metastatic Melanoma

Phase 2

Terminated

• Conditions: Melanoma Metastatic
• Interventions: Drug: Dacarbazine; Drug: Carmustine; Drug: Neulasta

• Registration Number: NCT01692691
• Lead Sponsor: Western Regional Medical Center

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...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2016-01-01
• Results First Submitted QC: 2016-01-01
• Results First Posted: 2016-02-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dacarbazine, carmustine, neulasta	Neulasta	Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
Dacarbazine, carmustine, neulasta	Dacarbazine	Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
Dacarbazine, carmustine, neulasta	Carmustine	Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Median Duration of Response	8 weeks	To determine the median duration of response for patients who received Dacarbazine and Carmustine
Response Rate	8 weeks	To determine the response rate after being treated with Dacarbazine Carmustine

Trial Locations

Locations (1)

Western Regional Medical Center; 🇺🇸 Goodyear, Arizona, United States