High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors

NCT05167370 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: Amifostine
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of amifostine to determine how effective it is in the reduction of infection in a high dose chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.

Conditions

Solid Tumors; Brain Tumors

Keywords

Solid Tumors; Brain Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence of Bacteriemia in a High Dose Busulfan, Melphalan and Thiotepa Chemotherapy Regimen With Autologous Peripheral Blood Stem Cell Rescue in Patients With High Risk and Relapsed or Refractory Pediatric Solid Tumors

  3 months

Study Arms (1)

Amifostine

EXPERIMENTAL

Drug: Amifostine

Interventions

Amifostine DRUG

Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on day -1 twenty four hours after prior dose of amifostine.

Also known as: Ethyol

Amifostine

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• High risk Ewing's Sarcoma Family Tumors (ESFT) including Ewing's Sarcoma, Askin's tumor, peripheral PNET
• High risk desmoplastic small round cell tumors (DSRCT)
• Relapsed Wilm's tumor, diffuse anaplastic Wilm's tumor
• High risk brain tumors including PNET/Medulloblastomas/germinomas
• Relapsed germ cell tumors
• Metastatic or relapsed rhabdoid tumors
• Other relapsed/refractory pediatric embryonal tumors
• Less than 30 years of age
• Performance \>= 50%
• Cancer Diagnosis verification and staging
• Disease Response and Recovery
• Adequate Organ Function (Renal, Liver, Cardiac)

You may not qualify if:

• Uncontrolled Infection
• Pregnancy or Breastfeeding (For Females)
• Disease Progression
• Uncontrolled Intercurrent Illness
• HIV Positive
• Receiving other Investigational Agents
• Amifostine Allergy

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Amifostine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Results Point of Contact

• Title: Dr. Sonata Jodele
• Organization: Cincinnati Children's Hospital Medical Center

Sonata.Jodele@cchmc.org

(513) 636-5917

Study Officials

• Sonata Jodele, MD

  CCHMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: December 22, 2021
• Study Start: December 13, 2010
• Primary Completion: April 29, 2011
• Study Completion: April 24, 2012
• Last Updated: January 25, 2022
• Results First Posted: January 25, 2022

Record last verified: 2021-12

Locations

US (1)