CHP-MAGE-A4 vaccine study for patients with advanced lung cancer

CHP-MAGE-A4 vaccine study for patients with advanced lung cancer - CHP-MAGE-A4 vaccine study for lung cancer patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001680

Enrollment

Registered

2009-03-01

Start date

2009-02-01

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

MAGE-A4-expressing therapy-resistant lung cancer

Interventions

Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 100 microgram,every week, repeated at least six cycles Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 300 microgram,every w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.MAGE-A4-expressing therapy-resistant lung cancer, with clinical stage III or IV, recurrent, metastatic disease, or at high-risk if reccurrence. 2.MAGE-A4-antigen expressing. 3.Performance status(ECOG) 0 to 2. 4.Aged twenty or more, male or female 5.At least four-month life expectancy 6.Normal major organ function, and meeting the criteria below White cell counts 2,000/uL or more. Hemoglobin 8.0 g/dl or more. Platelets 75,000/uL or more. Serum bilirubin: within 1.5 times of normal upper level(within 3 times in case of liver damage). AST(GOT)/ALT(GPT): within 2.5 times of normal upper level(within 5 times in case of liver damage). Serum creatinine within 1.5 times of normal upper level. 7.Not willing to be pregnant (both sexes) 8.Having written informed consent.

Exclusion criteria

Exclusion criteria: 1.HIV-positives. 2.Double cancers. 3.Autoimmune disease. 4.History of serious hypersensitivity. 5.Active CNS metastasis. 6.Lasting less than four weeks from the previous chemotherapy, systemic corticostoroid, immuno-suppressive or -stimulating agents, radiotherapy, or surgery to primary tumors 7.Pregnant or lactating. 8.Inappropriate for study entry judged by an attending physician.

Design outcomes

Primary

Measure	Time frame
Safety:maximum-tolerable dose, dose-limting toxicity, profiles of adverse events. Efficacy: MAGE-A4-specific immune responses	—

Secondary

Measure	Time frame
Efficacy:tumor responses, progression-free time, overall survival, response-duration time and time-to-progression	—

Countries

Japan

Contacts

Public ContactHanagiri Takeshi

University of Occupational and Environmental Health Second department of Surgery

hanagiri@med.uoeh-u.ac.jp093-691-7442

Outcome results

None listed

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