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

Phase 2TerminatedNCT05167370

Children's Hospital Medical Center, Cincinnati2 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors Brain Tumors

Interventions

AmifostineDRUG

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.

Eligibility

Sex: ALLMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 3 months

Data from ClinicalTrials.gov

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