Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Tokyo University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Pancreas Neoplasms; Pancreatic Cancer

Treatments: Biological: VEGFR1-A24-1084 (SYGVLLWEI)

Study type: Interventional

Funder types: Other

Identifiers

NCT00683358

IMSUT-PPKVEGFR12402

Details and patient eligibility

About

Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.

Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.

HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).

Full description

HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.

These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.

Enrollment: 14 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heterozygote or homozygote of HLA-A*2402 allele
• Inoperable or recurrent pancreatic cancer with or without any prior therapy
• Difficult to continue the prior therapy due to treatment-related toxicities
• ECOG performance status 0-2
• Evaluable primary or metastatic lesion with RECIST criteria
• Clearance period from prior therapy more than 4 weeks
• Life expectancy more than 3 months
• Laboratory values as follows 2,000/μL<WBC<15,000/μL Platelet count>100,000/μL AST<150IU/L ALT<150IU/L Total bilirubin<3.0mg/dl Serum creatinine<3.0mg/dl

Exclusion criteria

• Pregnancy (refusal or inability to use effective contraceptives)
• Breastfeeding
• Active or uncontrolled infection
• Systemic use of corticosteroids or immunosuppressants
• Uncontrollable brain metastasis and/or meningeal infiltration
• Unhealed external wound
• Possibilities of complicated paralytic ileus or interstitial pneumonitis
• Decision of not eligible determined by principal investigator or attending doctor

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

1

Experimental group

Treatment:

Biological: VEGFR1-A24-1084 (SYGVLLWEI)