0804 GCC: MAGE-A3/HPV 16 Vaccine for Squamous Cell Carcinoma of the Head and Neck

NCT00257738 | Completed Phase 1 DMC

• 2 other identifiers: HP-00041372R01DE015324
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Squamous Cell Carcinoma of the Head and Neck (SCCHN) is a devastating illness, the treatment of which is associated with significant morbidity. This type of cancer affects 43,000 individuals each year with an estimated survival rate of 50%. A potential treatment alternative for this patient population is the use of peptide-based immunotherapy. This clinical tial will be using a vaccines comprised on the Trojan peptides MAGE-A3 and HPV 16 to treat patients with Squamous Cell Carcinoma of the Head and Neck who have recurrent, progressive or metastatic SCCHN.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Number of participants experiencing toxicity

  Maximum grade of each toxicity and percentage of patients experiencing toxicity as assessed by CTCAE v4.0

  2 year

Secondary Outcomes (2)

• Tumor response

  4 years

• Tumor infiltrating lymphocytes

  4 years

Study Arms (2)

MAGE -A3 vaccine

EXPERIMENTAL

for those individuals in which tumor tests positive for MAGE-A3

Biological: MAGE-A3

HPV 16 vaccine

EXPERIMENTAL

for patients with HPV 16 positive tumor

Biological: HPV-16 vaccine

Interventions

MAGE-A3 BIOLOGICAL

Three dose levels of MAGE-A3 vaccine will be tested : 500ug, 1000 ug and 1500 ug

MAGE -A3 vaccine

HPV-16 vaccine BIOLOGICAL

Three dose levels of HPV- 16 vaccine will be tested : 500ug, 1000 ug and 1500 ug

HPV 16 vaccine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• 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
• One or more of the following: -MAGE-A3 positive tumor -HPV 16 positive tumor.
• Laboratory values obtained less than or equal to 30days prior to registration: -Alkaline phosphatase less than or equal to 3x upper normal limit (UNL) -AST less than or equal to 3x UNL -Creatinine less than or equal to 1.5 x UNL -Hemoglobin greater than or equal to 9.0 g/dL -Albumin greater than or equal to 3 mg/dL
• The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.
• 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.
• ECOG performance status 0-2.
• 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.

You may not qualify if:

• Any of the following:
• a. Known HIV infection, b. 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. c. 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) d. 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 patients life, should an Inflammatory Response occur.
• Any of the following prior therapies: Chemotherapy less than or equal to 4 weeks prior to registration Immunotherapy less than or equal to 4 weeks prior to registration Biologic therapy less than or equal to 4 weeks prior to registration Radiation therapy less than or equal to 4 weeks prior to registration
• 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.
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation).
• Either of the following: Other active cancer requiring therapy to control the disease History of other malignancy (i.e. excluding disease under study) within 3 years Exceptions to the above include: adequately treated basal cell or squamous cell skin cancer, prostate cancer.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1619, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

MAGEA3 protein, human

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Martin J. Edelman, MD

  University of Maryland, Greenebaum Cancer Ctr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 23, 2005
• Study Start: November 1, 2005
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

US (1)