NCT01807468

Brief Summary

To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation. To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

2.6 years

First QC Date

February 26, 2013

Last Update Submit

September 17, 2018

Conditions

NeuroblastomaEwing SarcomaRhabdomyosarcomaOsteosarcomaSoft Tissue Sarcoma

Keywords

haploidentical stem cell transplantationnatural killer cell therapypediatric solid tumor

Outcome Measures

Primary Outcomes (1)

  • Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion

    within 30 days after transplantation

Secondary Outcomes (1)

  • event-free survival and overall survival

    3 years after transplantation

Other Outcomes (1)

  • number of patients developing GVHD

    up to 1 year

Study Arms (1)

HaploSC+NK

EXPERIMENTAL
Procedure: haploidentical stem cell transplantation and NK cell therapy

Interventions

haploidentical stem cell transplantation and NK cell therapyPROCEDURE
HaploSC+NK

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age \< 21 years old
  • Patients with high-risk solid tumors who failed prior HDCT/autoSCT
  • Patients with a suitable haploidentical donor
  • High-risk solid tumors include high-risk neuroblastoma, metastatic or relapsed Ewing sarcoma, relapsed osteosarcoma, high-risk brain tumors, relapsed germ cell tumors, relapsed soft tissue sarcoma, relapsed rhabdomyosarcoma, and etc.
  • stable disease with salvage chemotherapy after relapse

You may not qualify if:

  • organ dysfunction(NCI common toxicity criteria grade \> 2)
  • progression of disease despite salvage chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

NeuroblastomaSarcoma, EwingRhabdomyosarcomaOsteosarcomaSarcoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueMyosarcomaNeoplasms, Muscle Tissue

Study Officials

  • Ki Woong Sung, MD, PhD

    Department of Pediatrics, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 8, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2015

Study Completion

June 1, 2019

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

KR(1)