Phase II clinical trial of personalized peptide vaccination with low dose cyclophosphamide for standard therapy failer non-small cell lung cancer patients

Phase II clinical trial of personalized peptide vaccination with low dose cyclophosphamide for standard therapy failer non-small cell lung cancer patients - Phae IIstudy of Peptide vaccination for standard therapy failed non-small cell lung cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005631

Enrollment

Registered

2011-05-23

Start date

2011-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

The cyclophosphamide of the low dosage (100mg 2x / day) is administered for seven days before the day of tha peptide vaccine beginning. Select vaccine peptides (up to 4) from 31 candidate peptides ,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects must be satisfactory the following conditions. 1) Patients with standard therapy failed non-small cell lung cancer(Stage IIIB/IV or recurrence).Presence of target lesion is not considered. 2) Patients must be at a score level 0-1 of ECOG performance status. 3) Patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types. 4) Patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings. WBC is more than 2500 per mm3 Lymphocyte is more than 1000 per mm3 Hb is more than 8.0 g per dL Platelet is more than 80000 per mm3 Serum creatinine is less than 2 times upper limit of normal. Total bilirubin is less than 2 times upper limit of normal. (for constitutional jaundice, 2.5 times less or equal) 6) Patients must be more than 20 years old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.

Exclusion criteria

Exclusion criteria: The following patients must be excluded. 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) (Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility. (Males) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4) Patients with pulmonary disorder ( idiopathic pulmonary fibrosis,interstitial pneumonia,pneumoconiosis,radiation pneumonia,drug-induced pneumonia). 5) Patients who are judged inappropriate for the clinical trial by doctors. 6)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.

Design outcomes

Primary

Measure	Time frame
Evaluation of immune responses (anti-peptide IgG,CTL) before and after personalized peptide vaccination.	—

Secondary

Measure	Time frame
1. overall survival 2. Adverse events of personalized peptide vaccination. Adverse events are evaluated by the NCI-CTCAE.	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division

akiymd@med.kurume-u.ac.jp0942-31-7744

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026