Phase I study of peptides derived from novel cancer antigens for advanced colorectal cancer

Conditions

colorectal cancer

Yoshitaro Shindo, Shoichi Hazama, Yusuke Nakamura, Yuka Inoue, Shinsuke Kanekiyo et al. (18 authors)

Oncology Letters2017-06-0225 citations

10.3892/ol.2017.6303

miR-196b and miR-486 as predictive biomarkers for the efficacy of the vaccine treatment: From the results of phase I and II studies for metastatic colorectal cancer.

Hiroaki Ozasa, Shoichi Hazama, Ryoichi Shimizu, Ryuichi Etoh, Yuka Inoue et al. (20 authors)

Journal of Clinical Oncology2015-05-201 citations

10.1200/jco.2015.33.15_suppl.e14001

A phase I study of combination vaccine treatment of five therapeutic epitope-peptides for metastatic colorectal cancer; safety, immunological response, and clinical outcome.

Hazama S, Nakamura Y, Takenouchi H, Suzuki N, Tsunedomi R, Inoue Y, Tokuhisa Y, Iizuka N, Yoshino S, Takeda K, Shinozaki H, Kamiya A, Furukawa H, Oka M.

2014-03-1069 citations

10.1186/1479-5876-12-63

Interventions

dose escalation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Unrespectable metastatic colorectal cancer and resistant for standard therapy. 2. Performance status 0-2 (ECOG) 3. Evaluable tumor lesion(s) 4. No major surgery, radiotherapy, or chemotherapy within 4 weeks prior to the study 5. predicted life expectancy of at least 3 months 6. Adequate baseline organ functions, defined as a leukocyte count of at least 2000 &#8260; lL, platelet count of at least 75000 / lL, and aspartate aminotransferase and alanine aminotransferase levels three times or less than the upper limit of the institutional reference range; and serum creatinine below 2.0 mg&#8260; dL. 7. with HLA-A2402 8. Written informed consent.

Exclusion criteria

Exclusion criteria: Serious infectious disease or other severe complications (e.g. pulmonary fibrosis / interstitial pneumonia, uncontrollable diabetes); pregnancy or lactation, or trying to get pregnant; a history of drug allergy

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and to find the recommended dose	—

Secondary

Measure	Time frame
Immunological effect Objective responses Overall survival	—

Countries

Japan

Contacts

Public ContactShoichi Hazama

Yamaguchi University Graduate School of Medicine Digestive surgery and surgical oncology

hazama@yamaguchi-u.ac.jp

Outcome results

None listed