Dacarbazine and Carmustine in Metastatic Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01692691
First received: August 29, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Melanoma Metastatic
Drug: Dacarbazine
Drug: Carmustine
Drug: Neulasta
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

Primary Outcome Measures:
  • progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • median duration of response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • median survival of patients treated with combination. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692691

Contacts
Contact: Marci Pierog, RN 623-207-3818 marci-pierog@ctca-hope.com
Contact: India L Hill 623-207-3392 india.hill@ctca-hope.com

Locations
United States, Arizona
Western Regional Medical Center Recruiting
Goodyear, Arizona, United States, 85338
Contact: Marci Pierog, RN    623-207-3818    marci.pierog@ctca-hope.com   
Principal Investigator: Walter Quan, MD         
Sponsors and Collaborators
Western Regional Medical Center
Investigators
Principal Investigator: Walter Quan, MD Western Regional Medical Center
  More Information

No publications provided

Responsible Party: Walter Quan Jr., MD, Principal Investigator, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01692691     History of Changes
Other Study ID Numbers: 12-10
Study First Received: August 29, 2012
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Western Regional Medical Center:
Melanoma Metastatic

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

ClinicalTrials.gov processed this record on September 29, 2014