|
|
|
|
|
Sponsors and Collaborators: |
University of Maryland National Institutes of Health (NIH) |
Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00704041 |
Squamous Cell Carcinoma of the Head and Neck (SCCHN) effects 43,000 individuals in the United States annually with an estimated overall survival of 50%. For some patients who develop local or distant metastases following primary therapy, surgery is not an option.
This study is being done to test the safety of experimental cancer vaccines made of MAGE-A3 and HPV-16 antigens. We also hope to learn what doses of the vaccine will best stimulate the immune system.
There will be 2 cohorts in this study, based on the results of tumor testing:
Cohort 1: Patients with tumor that is HPV 16 positive
Cohort 2: Patients with tumor that is MAGE-A3 positive
The doses of vaccine in both cohorts will be 500, 1000, or 1500 micrograms depending on when the patient is enrolled in the trial. Each vaccine treatment is every 2 weeks for 8 weeks, for a total of 4 vaccines doses.
Condition | Intervention | Phase |
Squamous Cell Carcinoma Head and Neck Cancer |
Biological: MAGE-A3 HPV-16 vaccine |
Phase I |
MedlinePlus related topics: | Cancer Head and Neck Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Open Label, Dose Escalation Study to Evaluate the Effect of Four Doses of MAGE-A3/HPV 16 Trojan Peptides 0001 and 0002 Administered Subcutaneously |
Estimated Enrollment: | 48 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Cohort 1: Experimental
Patients with tumor that is HPV 16 positive
|
Biological: MAGE-A3 HPV-16 vaccine
500, 1000, 1500 micrograms 4 times, biweekly
|
Cohort 2: Experimental
Patients with tumor that is MAGE-A3 positive
|
Biological: MAGE-A3 HPV-16 vaccine
500, 1000, 1500 micrograms 4 times, biweekly
|
Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One or more of the following:
Laboratory values obtained ≤30days prior to registration:
Exclusion Criteria:
Any of the following:
Any of the following prior therapies:
Any of the following:
NOTE: This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
Either of the following:
Contact: Martin J Edelman, MD | 410-328-2703 | medelman@umm.edu |
Contact: Jennifer DeSanto, RN | 410-328-6215 | jdesanto@smail.umaryland.edu |
United States, Maryland | |||||
University of Maryland, Greenebaum Cancer Center | Recruiting | ||||
Baltimore, Maryland, United States, 21201 | |||||
Contact: Jennifer 410-328-6215 | |||||
Sub-Investigator: Scott Strome, MD | |||||
Sub-Investigator: Jeffrey Wolf, MD | |||||
Sub-Investigator: Rodney Taylor, MD | |||||
Sub-Investigator: Duane Sewell, MD |
University of Maryland |
National Institutes of Health (NIH) |
Principal Investigator: | Martin J Edelman, MD | University of Maryland |
Responsible Party: | University of Maryland ( Scott Strome ) |
Study ID Numbers: | H-29776, UMGCC 0804 |
First Received: | June 20, 2008 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00704041 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|