Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
NCT ID: NCT00327600
Last Updated: 2010-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
68 participants
INTERVENTIONAL
2005-07-31
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
imexon + DTIC
imexon
DTIC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
imexon
DTIC
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to perform the activities of daily living.
* A projected life expectancy of at least 4 months.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* Blood cell counts and blood chemistries in or near normal range.
* Prior radiation is permitted.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No other current drug therapy for the cancer or steroid therapy.
Exclusion Criteria
* Brain metastases
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AmpliMed Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AmpliMed Corporation
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Evan Hersh, MD
Role: STUDY_DIRECTOR
AmpliMed Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigational Site 009
Los Angeles, California, United States
Investigational Site 002
Santa Monica, California, United States
University of CO Anschutz Cancer Pavilion
Aurora, Colorado, United States
US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, United States
US Oncology Albany, New York Oncology
Albany, New York, United States
US Oncology Kettering
Kettering, Ohio, United States
US Oncology Greenville, Cancer Centers of the Carolinas
Greenville, South Carolina, United States
US Oncology, Tyler Cancer Center
Tyler, Texas, United States
Investigational Site 012
Salt Lake City, Utah, United States
US Oncology, Virginia Oncology Assoc
Norfolk, Virginia, United States
US Oncology Spokane, Cancer Care Northwest
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Weber JS, Samlowski WE, Gonzalez R, Ribas A, Stephenson J, O'Day S, Sato T, Dorr R, Grenier K, Hersh E. A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma. Cancer. 2010 Aug 1;116(15):3683-91. doi: 10.1002/cncr.25119.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AMP-005
Identifier Type: -
Identifier Source: org_study_id
NCT00301132
Identifier Type: -
Identifier Source: nct_alias