Four Doses of MAGE Vaccine for Patients With Squamous Cell Carcinoma of the Head and Neck — MAGE  

Head and Neck Cancer Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Tests performed during this phase will assess the potential patients eligibility to participate in this study. The following will occur at this visit: 1. Review and completion of Health Insurance Portability and Accountability Act (HIPAA) consent and protocol informed consent documents Assessment of inclusion/ exclusion criteria Demographics and descriptive factors Physical examination Medical history Vital signs (blood pressure [BP], pulse rate, body temperature, body weight and heart rate.) Hematology Chemistry Thyroid-stimulating hormone (TSH) CT/PET Tumor biopsy to determine MAGE-A3 AND HPV 16 expression. Blood draw for HLA typing Concomitant medication recording Quality of Life (QOL) and Eastern Cooperative Toxicity Group (ECOG) status Serum pregnancy test Physical tumor measurements. Immune response blood draw (ELISPOT, recall assays, restimulation assays, tetramers, sequencing of MAGE-A3 and HPV 16- specific DNA, antigenic profiling) Review contraceptive plan. Prior to study enrollment, patients are to be seen by the Medical Oncologist and Surgical Oncologist. A consensus will be reached that the patient is or is not a suitable candidate for this trial based upon the Inclusion and Exclusion criteria. If after the Screening of a potential study subject for eligibility the subject does not meet eligibility requirements, he or she will not be enrolled into the study, after consensus is made by the aforementioned physicians. The blood and tissue specimens obtained by the screened but ineligible subject will be stored for subsequent analysis. If during the Screening Process the patient is unable to continue with Screening due to an illness, a family matter or other personal matter beyond that individuals control, and falls out of the Screening timeframe of 30 days as stated in the protocol, that patient can be re-screened at a later date if the individual wishes. In this case, the patient will be re-consented and re-screened.

TREATMENT PHASE

Day 1, Treatment #1 The following will occur at this visit:

Assessment of Inclusion/ Exclusion Criteria (these will be reassessed prior to the first vaccination to ensure patient eligibility) Physical examination Hematology and chemistry (obtained 24 hours prior to visit) Concomitant medication recording Adverse event recording QOL and ECOG status Serum pregnancy test (obtained 24 hours prior to visit) Physical tumor measurements. Immune response blood draw (ELISPOT, recall assays, restimulation assays, tetramers, sequencing of MAGE-A3 and HPV 16- specific DNA, antigenic profiling) Review contraceptive plan Review patient diary Administer vaccine treatment #1 Vital signs (BP, pulse rate, body temperature, body weight and heart rate.) evaluated pre dose and 0.5, 1, 2 and 4 hrs post-dose Evaluate injection site, evaluated immediately post-injection, 0.5, 1, 2 and 4 hrs post-dose

Day 15, Treatment #2 (+/-3 days) The following will occur at this visit:

Physical examination Adverse event recording QOL and ECOG status Physical tumor measurements. Immune response blood draw (ELISPOT, recall assays, restimulation assays, tetramers, sequencing of MAGE-A3 and HPV 16- specific DNA, antigenic profiling) Review contraceptive plan Review patient diary Administer vaccine treatment #2 Vital signs (BP, pulse rate, body temperature, body weight and heart rate.) evaluated pre dose and 0.5, 1, 2 and 4 hrs post-dose Evaluate injection site, evaluated immediately post-injection, 0.5, 1, 2 and 4 hrs post-dose

Day 29, Treatment #3 (+/-3 days) The following will occur at this visit:

Physical examination Chemistry (obtained 24 hours prior to visit) Concomitant medication recording Adverse event recording QOL and ECOG status Physical tumor measurements. Immune response blood draw (ELISPOT, recall assays, restimulation assays, tetramers, sequencing of MAGE-A3 and HPV 16- specific DNA, antigenic profiling) Review contraceptive plan Review patient diary Administer vaccine treatment #3 Vital signs (BP, pulse rate, body temperature, body weight and heart rate.) evaluated pre dose and 0.5, 1, 2 and 4 hrs post-dose Concomitant medication recording Evaluate injection site, evaluated immediately post-injection, 0.5, 1, 2 and 4 hrs post-dose

Day 43, Treatment #4 (+/-3 days) The following will occur at this visit:

Physical examination Adverse event recording QOL and ECOG status Physical tumor measurements. Immune response blood draw (ELISPOT, recall assays, restimulation assays, tetramers, sequencing of MAGE-A3 and HPV 16- specific DNA, antigenic profiling) Review contraceptive plan Review patient diary Administer vaccine treatment #4 Vital signs (BP, pulse rate, body temperature, body weight and heart rate.) evaluated pre dose and 0.5, 1, 2 and 4 hrs post-dose Concomitant medication recording Evaluate injection site, evaluated immediately post-injection, 0.5, 1, 2 and 4 hrs post-dose

POST-TREATMENT PHASE

Post-Treatment Phase, Follow Up, Day 57 (+/- 3days) The following will occur at this visit:

Physical examination Vital signs Tumor biopsy (unless in the view of the PI no tumor site is safely amenable for biopsy) Concomitant medication recording Adverse event recording QOL and ECOG status Physical tumor measurements. Immune response blood draw (ELISPOT, recall assays, restimulation assays, tetramers, sequencing of MAGE-A3 and HPV 16- specific DNA, antigenic profiling) Review contraceptive plan Review patient diary

Post- Treatment Phase, Month 3 through Month 24/ End of Study Follow Up (+/-7 days) The following will occur at these visits:

Physical examination Vital signs Hematology Chemistry Concomitant medication recording Adverse event recording QOL and ECOG status Physical tumor measurements. Immune response blood draw (ELISPOT, recall assays, restimulation assays, tetramers, sequencing of MAGE-A3 and HPV 16- specific DNA, antigenic profiling) Review contraceptive plan Review patient diary ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Squamous Cell Carcinoma

• NCT number: NCT00704041
• Study type: Interventional
• Source: University of Maryland
• Contact: Martin J Edelman, MD
• Phone: 410-328-2703
• Email: medelman@umm.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: July 2009
• Completion date: June 2012