A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1 - Full Text View

Sponsor:	Celldex Therapeutics
Information provided by (Responsible Party):	Celldex Therapeutics
ClinicalTrials.gov Identifier:	NCT00948961

Purpose

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 express the NY-ESO-1 protein.

Condition	Intervention	Phase
Advanced Malignancies	Biological: CDX-1401 in combination with Resiquimod and/or Poly-ICLC	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:

Occurrence of adverse events (side effects) [ Time Frame: 12 weeks (1 cycle of study treatment) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Objective response rate (CR/PR), disease control rate (CR/PR/SD) and time to progression, based on disease-appropriate response criteria. [ Time Frame: 12 week intervals ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	September 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Intervention Details:

CDX-1401 is administered as an injection into the skin every 2 weeks for 4 doses. It is given in combination with Resiquimod and/or poly-ICLC. Resiquimod is administered as a topical gel applied to the skin or given as an injection under the skin, and poly-ICLC is given as an injection under the skin. Depending on the treatment group assignment, either one or both of the immune stimulants will be given on the day of and the day after CDX-1401 administrations. This treatment may be repeated every 12 weeks.

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 target against which to stimulate an immune response that may destroy cancer cells. CDX-1401 is a cancer vaccine that is specially designed to create this type of immune response. To enhance the immune response, CDX-1401 will be given with 1 or 2 immune stimulants called Resiquimod and poly-ICLC (Hiltonol).

This clinical trial includes Phase 1 and Phase 2 segments. During the Phase 1 segment, six groups of 6 to 24 patients will be treated with different dose levels of CDX-1401 in combination with either one or both of the immune stimulants (Resiquimod and/or poly-ICLC). This phase of the study will test the safety profile of the vaccine treatment, and will assess which dose to test in future studies. During the Phase 2 segment, 14 patients whose cancer tested positive for the NY-ESO-1 protein in laboratory testing, will receive the study treatment to determine if it has an effect on their cancer. All patients enrolled in either part of the study may continue to receive study treatment until their disease has progressed or until it is necessary to stop the treatment for safety or other reasons. In addition, all patients will be "followed" for 24 months after enrollment in order to collect survival information.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948961

Locations

United States, Connecticut
Yale Comprehensive Cancer Center	Recruiting
New Haven, Connecticut, United States, 06519-1717
Contact: Madhav Dhodapkar, MD 203-785-4144 Madhav.dhodpakar@yale.edu
Contact: Mario Sznol, MD (203) 785-7836 Mario.sznol@yale.edu
Principal Investigator: Madhav Dhodapkar, MD
United States, Florida
Mount Sinai Comprehensive Cancer Center	Recruiting
Miami Beach, Florida, United States, 33140
Contact: Yvonne Enriquez-Nunez, BSHA 305-535-3350 yenrique@msmc.com
Contact: Rhea Howell 305-674-2121 ext 55602 rhea.howell@msmc.com
Principal Investigator: Jose Lutzky, MD
United States, Michigan
Henry Ford Health System	Recruiting
Detroit, Michigan, United States, 48202
Contact: Nikki Adams, RN 313-916-8862 nadams1@hfhs.org
Contact: Ding Wang, MD (313) 916-0131 dwang1@hfhs.org
Principal Investigator: Ding Wang, MD
United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10017
Contact: Mary L Keohan, MD 212-639-2809 keohanm@mskcc.org
Contact: Catherine Hirst 646-227-2171 hirstc@mskcc.org
Principal Investigator: Mary L Keohan, MD
Weill Cornell Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Ellen Chuang, MD 212-821-0654 elc2007@med.cornell.edu
Contact: Marta Cobham, RN (212) 821-0780 mac2034@med.cornell.edu
Principal Investigator: Ellen Chuang, MD
United States, North Carolina
Carolina BioOncology Institute, PLLC	Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Jahleen Byers 704-947-6599 ext 103 jbyers@carolinabiooncology.org
Principal Investigator: John Powderly, MD
United States, Oregon
Providence Portland Cancer Center	Recruiting
Portland, Oregon, United States, 97213
Contact: Brenda Fisher, RN 503-215-2613 brenda.fisher@providence.org
Contact: Scot Lary, RN 503-215-2604 john.lary@providence.org
Principal Investigator: Rachel Sanborn, MD

Sponsors and Collaborators

Celldex Therapeutics

More Information

No publications provided

Responsible Party:	Celldex Therapeutics
ClinicalTrials.gov Identifier:	NCT00948961 History of Changes
Other Study ID Numbers:	CDX1401-01
Study First Received:	July 28, 2009
Last Updated:	November 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celldex Therapeutics:

NYESO1
cancer vaccine
immunotherapy
breast cancer
ovarian cancer
non-small cell lung cancer
myeloma
sarcoma

melanoma
Resiquimod
Poly-ICLC
Hiltonol
esophageal cancer
bladder cancer
chondrosarcoma
adenocarcinoma

Additional relevant MeSH terms:

Neoplasms
Poly ICLC
Interferon Inducers

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012