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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
to test the safety of the experimental cancer vaccines made of MAGE-A3 and HPV-16 antigens
ongoing
Yes
Martin J Edelman, MD
Principal Investigator
University of Maryland
United States: Food and Drug Administration
HP-41372
NCT00704041
July 2009
June 2012
Name | Location |
---|---|
University of Maryland, Greenebaum Cancer Center | Baltimore, Maryland 21201 |