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

Phase 2

Completed

• Conditions: soft tissue sarcoma

• Registration Number: JPRN-jRCT1091220276

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-17
• Study Completion: 2021-03-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event free survival

Secondary Outcome Measures

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