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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05167370
• Other study ID #: Amifostine
• Status: Terminated
• Phase: Phase 2
• Start date: December 13, 2010
• Est. completion date: April 24, 2012

Study information

• Verified date: December 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Autologous stem cell transplant (ASCT) permits chemotherapy dose-escalation to exploit the steep dose-response of solid tumors to alkylating agents. Although ASCT regimens have activity in some high risk pediatric solid tumors, non-hematological regimen-related morbidity and mortality are major barriers to additional dose escalation. We hypothesized that the chemoprotectant amifostine (Ethyol®) would reduce the toxicity of ASCT without compromising anti-tumor efficacy. This is a study of amifostine at 1125 mg/m2 to determine the efficacy of it's chemoprotection in the reduction of bacteremia in a high dose busulfan, melphalan and thiotepa chemotherapy regimen with autologous stem cell rescue in children with high risk, relapsed or refractory pediatric solid tumors.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 24, 2012
• Est. primary completion date: April 29, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Uncontrolled Infection

• Pregnancy or Breastfeeding (For Females)

• Disease Progression

• Uncontrolled Intercurrent Illness

• HIV Positive

• Receiving other Investigational Agents

• Amifostine Allergy

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors
• Neoplasms
• Solid Tumors

Intervention

Drug:
• Amifostine
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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