Status:
COMPLETED
A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
Lead Sponsor:
Celldex Therapeutics
Conditions:
Advanced Malignancies
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of this study is to examine the safety and tolerability of CDX-1401 when given in combination with an immune stimulant (resiquimod) to patients with advanced cancers that are known to...
Detailed Description
NY-ESO-1 is a protein that is often made by some types of tumor cells, but only made by a few types of normal cells. Because it is primarily made by cancer cells, the NY-ESO-1 protein is a promising t...
Eligibility Criteria
Inclusion
- Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:
- 18 years of age or older.
- Have a cancer type that is known to express NY-ESO-1, including (but not limited to) cancer of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma or melanoma.
- Have cancer that has progressed after any therapies with curative potential or approved salvage therapies (if such therapies exist).
- Have evaluable or measurable tumors.
- Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
- Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory.
- If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.
Exclusion
- Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:
- Are receiving treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (inhaled or topically applied steroids are permitted).
- Has a known infection with HIV, HBV or HCV, or any other active infection requiring systemic antibiotic treatment.
- Has active central nervous system tumors.
- Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous or otherwise interfere with the study.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00948961
Start Date
September 1 2009
End Date
February 1 2014
Last Update
June 27 2016
Active Locations (7)
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1
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06519-1717
2
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10017