Peptides cocktail vaccine for patients with progressive or recurrent malignant glioma.

JRCT ID: jRCTs031180148

Registered date:22/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: malignant glioma
• Date of first enrollment: 12/03/2014
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Subcutaneous injections of URLC10, DEPDC1, FOXM1, KIF20A, VEGFR1 and VEGFR2 peptides (1mg, respectively) with IFA. In principle, weekly administration, 8 times and then monthly administration, 6 times; total 14 times. Weekly administration, 8 times and then monthly administration, 6 times; total 14 times. Peptides are injected 8 times every week (plus or minus 2 days), then 6 times monthly thereafter (plus or minus 7 days) ; total of 14 times.

Outcome(s)

• Primary Outcome: safety, effectiveness
• Secondary Outcome: tumor volume reduction effect, PFS

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1) malignant glioma.
2) HLA-A*2402.
3) Age between 16 to 79.
4) Performance status (ECOG) of 0-2.
5) After the postoperative treatment with temozolomide and irradiation.
6) Over 4 weeks after chemotherapy and/or irradiation
7) Sufficient function of important organs.
8) No uncontrollable pleural, peritoneal or cardiac effusion.
9) Expected survival time: more than 3 months.
10) Written informed consents are obtained.

Exclude criteria

1) Uncontrollable severe infectious diseases.
2) Serious concomitant diseases
3) Adverse event of NCI-CTC grade 3 or 4.
4) Unable to take anything orally over 24 hours.
5) Active multiple cancers.
6) Myeloproliferative diseases such as MDS and CML.
7) After allogeneic hematopoietic stem cell transplantation.
8) Active autoimmune diseases.
9) Severe drug allergy
10) Necessity for administration of steroid or immunosuppressive drugs.
11) Pregnancy or lactation. Patients hope pregnancy
12) Psychiatric disorders.
13) Unhealed injury.
14) Judged as inappropriate for this study by doctors.

Related Information

• Primary Sponsor: Toda Masahiro
• Secondary ID(s): UMIN000012774