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Four Doses of MAGE Vaccine for Patients With Squamous Cell Carcinoma of the Head and Neck
This study is currently recruiting participants.
Verified by University of Maryland, July 2009
First Received: June 20, 2008   Last Updated: July 8, 2009   History of Changes
Sponsor: University of Maryland
Collaborator: National Institutes of Health (NIH)
Information provided by: University of Maryland
ClinicalTrials.gov Identifier: NCT00704041
  Purpose

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

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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • to test the safety of the experimental cancer vaccines made of MAGE-A3 and HPV-16 antigens [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to learn what doses of the vaccine will best stimulate the immune system [ Time Frame: at study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2009
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

  Eligibility

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

Inclusion Criteria:

  1. Age 18 or older.
  2. Biopsy proven progressive, recurrent (post-surgical, radiation therapy, chemotherapy, combination therapy), or metastatic SCC of the head and neck which, in the judgment of the attending physician, is incurable by standard treatment modalities, OR Biopsy proven SCC which the patient is unwilling to have treated with surgery, chemotherapy or radiation therapy.
  3. One or more of the following:

    • MAGE-A3 positive tumor
    • HPV 16 positive tumor.
  4. Laboratory values obtained ≤30days prior to registration:

    • Alkaline phosphatase ≤3 x upper normal limit (UNL)
    • AST ≤3 x UNL
    • Creatinine ≤1.5 x UNL
    • Hemoglobin ≥9.0 g/dL
    • Albumin ≥3 mg/dL
  5. The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.
  6. The subject must be willing to return to the University of Maryland Medical center for treatment and study-related follow up procedures including blood and tumor collections and completion of imaging studies as required by the protocol.
  7. Life expectancy 6 months or greater (in the judgment of the Medical Oncologist/Co-Investigator).
  8. Tumor that is biopsy accessible and measurable. This includes, but is not limited to, open biopsy, endoscopic biopsy, image guided biopsy, core biopsy and fine needle aspiration.

Exclusion Criteria:

  1. ECOG performance status 3 or 4.
  2. Any of the following:

    • Known HIV infection,
    • Other circumstances (i.e. concurrent use of systemic immunosuppressants and immunocompromising condition) that in the opinion of the physician renders the patient a poor candidate for this trial.
    • Patients with ANY malignant or metastatic SCC mass or lesion within the Central Nervous System (CNS). (e.g. intraparenchymal - brain, intracordal / spinal canal, bony masses or lesions with extension into the CNS parenchyma)
    • Patients with ANY malignant or metastatic SCC mass or lesion or a volume of a mass or lesion in a location that in the judgment of the investigator may significantly impair the health of or threaten the patient's life, should an Inflammatory Response occur.
  3. Any of the following prior therapies:

    • Chemotherapy < 4 weeks from the date of first vaccination
    • Immunotherapy < 4 weeks from the date of first vaccination
    • Biologic therapy < 4 weeks from the date of first vaccination
    • Radiation therapy < 4 weeks from the date of first vaccination
  4. Any of the following:

    • Pregnant women
    • Nursing women unwilling to stop breastfeeding
    • Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.).

    NOTE: This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.

  5. Other concurrent chemotherapy, immunotherapy, radiotherapy, device, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation).
  6. Either of the following:

    • Other active cancer requiring therapy to control the disease
    • History of other malignancy (i.e. excluding disease under study) ≤3 years. Exceptions to the above include: adequately treated basal cell or squamous cell skin cancer, prostate cancer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704041

Contacts
Contact: Martin J Edelman, MD 410-328-2703 medelman@umm.edu
Contact: Jennifer DeSanto, RN 410-328-6215 jdesanto@smail.umaryland.edu

Locations
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            
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Martin J Edelman, MD University of Maryland
  More Information

No publications provided

Responsible Party: University of Maryland ( Scott Strome )
Study ID Numbers: HP-41372, UMGCC 0804
Study First Received: June 20, 2008
Last Updated: July 8, 2009
ClinicalTrials.gov Identifier: NCT00704041     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
squamous cell carcinoma
head and neck cancer
vaccine

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 20, 2009