High-dose Chemotherapy With Autologous Stem Cell Rescue in Pediatric High-risk Brain Tumors

Sponsor

Samsung Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00798811

Collaborator

KSPNO stem cell transpantation committee (Other)

100

Enrollment

Location

Arms

195

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study No.: KSPNO-S-081 Reduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor
Study No.: KSPNO-S-082 High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce Craniospinal Radiation
Study No.: KSPNO-S-083 High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate Response to Conventional Treatment

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor	Procedure: high-dose chemotherapy and autologous stem cell rescue Procedure: high-dose chemotherapy and autologous stem cell rescue Procedure: high-dose chemotherapy and autologous stem cell rescue	Phase 2

Detailed Description

Although significant progress has been made in the treatment of brain tumors, the prognosis remains dismal in patients with relapsed tumor. The outlook for infants and young children is also poor, primarily because of the limited use of radiotherapy, although a recent report suggested that vigorous combination chemotherapy alone improved the survival of young children without macroscopic metastases at diagnosis. The prognosis is also not satisfactory when a large residual tumor remains after surgery or when leptomeningeal seeding is present at diagnosis. Given the above situation, we plan to explore the possible efficacy of high-dose chemotherapy and autologous stem cell rescue in patients with high-risk embryonal tumors, relapsed brain tumors and in infants and young children with brain tumors.High-dose chemotherapy and autologous stem cell rescue has improved the survival of children with high-risk solid tumors. this treatment strategy is based on the hypothesis that a dose escalation might improve the survival of children with high-risk solid tumors.Many investigators demonstrated that further dose escalation using sequential high-dose chemotherapy and autologous stem cell rescue might result in additional improvements in the survival of patients with high-risk tumors. As embryonal brain tumors are a chemosensitive tumors, a strategy using high-dose chemotherapy might be effective in the treatment of high-risk embryonal brain tumors and relapsed brain tumors. In addition, it might defer or eliminate irradiation in infants and young children with brain tumors

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter Clinical Trial to Evaluate Efficacy of High-dose Chemotherapy With Autologous Stem Cell Rescue for Children With High-risk Brain Tumors

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: KSPNO-S-081 Reduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor	Procedure: high-dose chemotherapy and autologous stem cell rescue Surgery -> enroll Pre-RT chemotherapy (2 cycles: A1, B1) PBSC collection during first cycle (A1) (2nd look surgery if necessary) RT (Reduced dose CSI) Post-RT chemotherapy (4 cycles: A2, B2, A3, B3) (if relapse or progression prior to HDCT, off study -> enroll S-083 protocol) HDCT1 (CTE) HDCT2 (CM)
Other: KSPNO-S-082 High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce Craniospinal Radiation	Procedure: high-dose chemotherapy and autologous stem cell rescue Surgery pre-HDCT chemotherapy (6 cycles: A1, B1, A2, B2, A3, B3) PBSC collection during first cycle of chemotherapy (A1) (2nd look surgery if necessary) (if relapse or progression prior to HDCT, off study -> enroll S-083 protocol) HDCT1 (CTE) HDCT2 (CM) (RT if necessary) Observe
Other: KSPNO-S-083 High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate Response to Conventional Treatment	Procedure: high-dose chemotherapy and autologous stem cell rescue (Surgery if possible) Chemotherapy (4 cycles) PBSC collection during first cycle of chemotherapy during 4th cycle of chemotherapy (if BM involvement) (RT, if possible, after PBSC collection) (if less than PR prior to HDCT, off study) HDCT1 (CTE) HDCT2 (CM)

Arm

Intervention/Treatment

Other: KSPNO-S-081

Reduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor

Procedure: high-dose chemotherapy and autologous stem cell rescue

Surgery -> enroll Pre-RT chemotherapy (2 cycles: A1, B1) PBSC collection during first cycle (A1) (2nd look surgery if necessary) RT (Reduced dose CSI) Post-RT chemotherapy (4 cycles: A2, B2, A3, B3) (if relapse or progression prior to HDCT, off study -> enroll S-083 protocol) HDCT1 (CTE) HDCT2 (CM)

Other: KSPNO-S-082

High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce Craniospinal Radiation

Procedure: high-dose chemotherapy and autologous stem cell rescue

Surgery pre-HDCT chemotherapy (6 cycles: A1, B1, A2, B2, A3, B3) PBSC collection during first cycle of chemotherapy (A1) (2nd look surgery if necessary) (if relapse or progression prior to HDCT, off study -> enroll S-083 protocol) HDCT1 (CTE) HDCT2 (CM) (RT if necessary) Observe

Other: KSPNO-S-083

High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate Response to Conventional Treatment

Procedure: high-dose chemotherapy and autologous stem cell rescue

(Surgery if possible) Chemotherapy (4 cycles) PBSC collection during first cycle of chemotherapy during 4th cycle of chemotherapy (if BM involvement) (RT, if possible, after PBSC collection) (if less than PR prior to HDCT, off study) HDCT1 (CTE) HDCT2 (CM)

Outcome Measures

Primary Outcome Measures

overall survival, event-free survival [one year]

Secondary Outcome Measures

toxicity [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

KSPNO-S-081: newly diagnosed embryonal brain tumor, age >= 3 years
KSPNO-S-082: all high-grade or malignant brain tumor, age <3 years
KSPNO-S-083: recurrent embryonal brain tumors, recurrent CNS germ cell tumor

Exclusion Criteria:

Patients with severe comorbid organ dysfunction (NCI grade > 2 organ toxicity) prior to high-dose chemotherapy
Patients with progressed tumor prior to high-dose chemotherapy
Patients whose parents do not want to undergo high-dose chemotherapy and autologous stem cell rescue

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center
KSPNO stem cell transpantation committee

Investigators

Principal Investigator: Ki Woong Sung, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00798811

Other Study ID Numbers:

2005-12-009

First Posted:

Nov 26, 2008

Last Update Posted:

Mar 19, 2020

Last Verified:

Mar 1, 2020

Keywords provided by , ,

brain tumor

high-dose chemotherapy

autologous stem cell transplantation

infant

Additional relevant MeSH terms:

Brain Neoplasms

Study Results

No Results Posted as of Mar 19, 2020