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Dacarbazine and Carmustine in Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01692691
Recruitment Status : Terminated (PI decision)
First Posted : September 25, 2012
Results First Posted : February 2, 2016
Last Update Posted : February 20, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Melanoma Metastatic Drug: Dacarbazine Drug: Carmustine Drug: Neulasta Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma
Study Start Date : August 2012
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dacarbazine, carmustine, neulasta
Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3
Drug: Dacarbazine
Dacarbazine IV - Day 1
Other Name: DTIC
Drug: Carmustine
Carmustine IV- Day 2
Other Name: BCNU
Drug: Neulasta
Neulasta SC - Day 3
Other Name: pegfilgrastim

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 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 :
  1. Response Rate [ Time Frame: 8 weeks ]
    To determine the response rate after being treated with Dacarbazine Carmustine

  2. Median Duration of Response [ Time Frame: 8 weeks ]
    To determine the median duration of response for patients who received Dacarbazine and Carmustine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692691

United States, Arizona
Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
Study Director: Jordan Waypa, FNP CTCA

Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01692691     History of Changes
Other Study ID Numbers: 12-10
First Posted: September 25, 2012    Key Record Dates
Results First Posted: February 2, 2016
Last Update Posted: February 20, 2018
Last Verified: January 2018

Keywords provided by Western Regional Medical Center:
Melanoma Metastatic

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents