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Phase I Study of Chemoradiation Therapy With Epitope Peptide Vaccine Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer


Phase 1
20 Years
80 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

Phase I Study of Chemoradiation Therapy With Epitope Peptide Vaccine Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer


Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain
containing protein over expressed in cancer (KOC1) were identified as new targets of tumor
associated antigens using cDNA microarray technologies combined with the expression profiles
of normal and cancer tissues. Furthermore, anti-angiogenic therapy is now considered to be
one of promising approaches for treating cancer. Vascular endothelial growth factor receptor
1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) are essential targets
for tumor angiogenesis. Epitope peptides for these targets are able to induce cytotoxic T
lymphocytes (CTL) restricted to HLA-A *2402 in vivo. On the other hand, chemotherapy
(CDDP, 5-FU) plus radiation therapy has been to be a standard treatment for unresectable
advanced esophageal cancer. In this clinical trial, we evaluate the safety and immune
responses of different doses of multiple peptides (URLC10, TTK, KOC1, VEGFR1, and VEGFR 2)
emulsified with Montanide ISA 51 in combination with chemotherapy (CDDP, 5-FU) plus
radiation therapy in treating patients with unresectable, advanced or recurrent esophageal
cancer.


Inclusion Criteria:



1. Patients must have unresectable, locally advanced, recurrent or metastatic disease of
esophageal cancer.

2. measurable disease by CT scan

3. ECOG performance status of 0 to 2

4. Expected survival of at lease 3months

5. Patients must be HLA-A2402

6. Laboratory values as follow:

- WBC > 2000/mm3,

- Platelet count > 75000/mm3,

- Total bilirubin < 1.5 x the institutional normal upper limits,

- Creatinine < 1.5 x the institutional normal upper limits,

- AST. ALT. ALP < 2.5 x the institutional normal upper limits

7. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential:Refusal or inability to use effective
means of contraception)

2. Breastfeeding

3. Active or uncontrolled infection

4. Prior chemotherapy,radiation therapy or immunotherapy within 4 weeks

5. Concurrent treatment with steroid or immunosuppressing agent

6. Patient with peptic ulcer disease

7. Active or uncontrolled other malignancy

8. Other malignancy within 5 years prior to entry into the study, expect for treated
non-melanoma skin cancer and cervical carcinoma in situ

9. Disease to the central nervous system

10. Decision of unsuitableness by principal investigator or physician-in-charge

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety(toxicities as assessed by NCI CTCAE version3)

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Kota Okinaga, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Teikyo University , Department Surgery

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

TPR07-079

NCT ID:

NCT00632333

Start Date:

February 2008

Completion Date:

March 2012

Related Keywords:

  • Esophageal Cancer
  • Epitope peptide
  • Vaccination
  • Chemoradiation
  • Esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

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