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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Carcinoma, Head and Neck Cancer

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

to test the safety of the experimental cancer vaccines made of MAGE-A3 and HPV-16 antigens

Outcome Time Frame:

ongoing

Safety Issue:

Yes

Principal Investigator

Martin J Edelman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland

Authority:

United States: Food and Drug Administration

Study ID:

HP-41372

NCT ID:

NCT00704041

Start Date:

July 2009

Completion Date:

June 2012

Related Keywords:

  • Squamous Cell Carcinoma
  • Head and Neck Cancer
  • squamous cell carcinoma
  • head and neck cancer
  • vaccine
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Maryland, Greenebaum Cancer CenterBaltimore, Maryland  21201