Dacarbazine and Carmustine in Metastatic Melanoma

NCT01692691 | Terminated Phase 2 Results

• 1 other identifier: 12-10
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma Metastatic

Keywords

Melanoma Metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Response Rate

  8 weeks

• Median Duration of Response

  8 weeks

Study Arms (1)

Dacarbazine, carmustine, neulasta

EXPERIMENTAL

Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3

Drug: Dacarbazine; Drug: Carmustine; Drug: Neulasta

Interventions

Dacarbazine DRUG

Dacarbazine IV - Day 1

Also known as: DTIC

Dacarbazine, carmustine, neulasta

Carmustine DRUG

Carmustine IV- Day 2

Also known as: BCNU

Dacarbazine, carmustine, neulasta

Neulasta DRUG

Neulasta SC - Day 3

Also known as: pegfilgrastim

Dacarbazine, carmustine, neulasta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Regional Medical Center: lead

Study Sites (1)

Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

MeSH Terms

Interventions

Dacarbazine; Carmustine; pegfilgrastim

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds

Results Point of Contact

• Title: Jessica L. Coats
• Organization: Western Regional Medical Center

jessica.coats@ctca-hope.com

623-207-3899

Study Officials

• Jordan Waypa, FNP

  CTCA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: September 25, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 4, 2018
• Results First Posted: February 2, 2016

Record last verified: 2018-03

Locations

US (1)