Trial Outcomes & Findings for Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer (NCT NCT00683085)

Results Overview

Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

2 months

Results posted on

2011-07-22

Participant Flow

Neighboring research hospitals around Tokyo, Japan sent three candidates to our hospital during May, 2008 to March, 2009.

Wash out time was four weeks from preceding therapy, and three candidates were evaluated for eligibility. Two cases were compatible to our eligibility, but another candidate was excluded from this study entry because he was not expected to survive more than three months.

Participant milestones

Participant milestones
Measure	Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine HLA-A\*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m\^2 of body surface area
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine n=2 Participants HLA-A\*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m\^2 of body surface area
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 7.07 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Intention to treat (ITT)

Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)

Outcome measures

Outcome measures
Measure	Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine n=2 Participants HLA-A\*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m\^2 of body surface area
Number of Participants Without Grade 4 Hematological or Grade 3 to 4 Non-hematological Adverse Events	1 participants

SECONDARY outcome

Timeframe: 2 months

Population: intension to treat (ITT)

Sum of diameters of primary pancreatic tumor or metastatic tumors (target lesions) before and after vaccination were measured by computed tomography. Sum of tumors' size diameters decrease more than 30% after vaccination was diagnosed as response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines.

Outcome measures

Outcome measures
Measure	Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine n=2 Participants HLA-A\*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m\^2 of body surface area
Number of Participants With Tumor Regression	0 participants

Adverse Events

Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine n=2 participants at risk HLA-A\*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m\^2 of body surface area
Gastrointestinal disorders Blood in stool	50.0% 1/2 • Number of events 2 • During 2 months after initiation of vaccination Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events

Other adverse events

Other adverse events
Measure	Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine n=2 participants at risk HLA-A\*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m\^2 of body surface area
Blood and lymphatic system disorders Hemoglobin	50.0% 1/2 • Number of events 1 • During 2 months after initiation of vaccination Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events
Blood and lymphatic system disorders Leukocytes	100.0% 2/2 • Number of events 2 • During 2 months after initiation of vaccination Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events
Blood and lymphatic system disorders Lymphopenia	50.0% 1/2 • Number of events 1 • During 2 months after initiation of vaccination Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events
Blood and lymphatic system disorders Neutrophils	100.0% 2/2 • Number of events 2 • During 2 months after initiation of vaccination Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events
Blood and lymphatic system disorders Platelets	50.0% 1/2 • Number of events 1 • During 2 months after initiation of vaccination Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events
Skin and subcutaneous tissue disorders Injection site reaction	100.0% 2/2 • Number of events 2 • During 2 months after initiation of vaccination Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events

Additional Information

Hitomi Nagayama, M.D., Ph.D. / Project Lecturer

Research Hospital, The Institute of Medical Science, The University of Tokyo

Phone: +81-3-3443-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place