A phase II randomized controlled trial of WT1 peptide vaccine (DSP-7888) therapy in patients with childhood, adolescent and young adult soft tissue sarcoma.

JRCT ID: jRCT1091220276

Registered date:17/02/2017

Basic Information

• Recruitment status: COMPLETED
• Health condition(s) or Problem(s) studied: soft tissue sarcoma
• Date of first enrollment: 31/07/2017
• Target sample size: 54
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention type:DRUG
Name of intervention:WT1 peptide vaccine (DSP-7888)
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRADERMAL
Dose per administration:3.5
mg
Dosing frequency / Frequency of use:OTHER, SPECIFY
every 7 days (until 5th dose), every 14 days (6th dose-15th dose), every 28 days (16th dose-)
Planned duration of intervention:The intervention will continue until principal investigator judges that clinical benefit is no longer obtained.
Intended dose regimen:WT1 peptide vaccine monotherapy
detailes of teratment arms:
Comparative intervention name:
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Outcome(s)

• Primary Outcome: Event free survival

Secondary Outcome

1. Overall survival
2. Event free survival by HLA-A locus, WT1 expression and disease characteristics
3. Survival by WT1 antigen specific immune reaction (WT1 tetramer analysis, WT1 specific IgG, delayed type hypersensitivity)
4. Frequency of adverse events

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 30age old
• Gender: Both

Include criteria

1)
High risk rhabdomyosarcoma defined by JRS-II risk group classification.
1. Rhabdomyosarcoma with distant metastasis at diagnosis.
2. Alveolar rhabdomyosarcoma of unfaborable site origin with macroscopic residual disease at diagnosis.
Patients with rhabdomyosarcomamust be in complete remission or must have no FDG avid lesion at enrollment.

Non-rhabdomyosarcoma with features described below.
3. grossly resected high grade tumor with diameter of 5cm or larger.
4. localized tumor which is unresected at diagnosis.
5. regional lymph node metastasis and/or distant metastasis at diagnosis except low grade tumor where all lesions are resected.
Patients with non-rhabdomyosarcoma soft tissue sarcoma must be in complete remission at enrollment.
2) Enrollment within 120 days after last chemotherapy, surgery or irradiation.
3) ECOG 0-2 (>=16 years old) or Lansky 50-100% (< 16 years old)
4) Patients must have sufficient organ function.
5) Age younger than 30 years old.
6) All patients and/or their parents or legal guardians must sign a written informed consent.

Exclude criteria

1) patients with synchronous or metachronous concomitant malignancies
2) patients receiving chemotherapy
3) patients with uncontrollable complications
4) patients with uncontrollable infection
5) patients with severe psychotic disorder
6) Female patients who are pregnant or patients considering pregnancy
7) patients who have not agreed to use an effective contraceptive method.
8) patients who plan to participate in other clinical trials with intervention during this clinical trial.
9) Patients with any other inappropriate condition judged by physician

Related Information

• Source(s) of Monetary Support: Japan Medical Association
• Secondary ID(s): JMA-IIA00276