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TerminatedNCT05167370Updated Jan 25, 2022Results posted

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

A Phase 2 interventional study of Amifostine in Solid Tumors and Brain Tumors, sponsored by Children's Hospital Medical Center, Cincinnati. Terminated at 1 site in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2022-01-25.

Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 2, Interventional, and Treatment

Why this study was terminated
The study was terminated as recommended by the DSMB due to inability to meet enrollment goals within the time frame allotted (target of 25 patients over 5 years).

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Dec 2010, registered Aug 2012).
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
Up to 30 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Solid Tumors
  • Brain Tumors

Keywords

  • Solid Tumors
  • Brain Tumors
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 2 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Uncontrolled Infection
  • Pregnancy or Breastfeeding (For Females)
  • Disease Progression
  • Uncontrolled Intercurrent Illness
  • HIV Positive
  • Receiving other Investigational Agents
  • Amifostine Allergy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Amifostine

    Drug: Amifostine

Interventions

  • DrugAmifostine

    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

06

What researchers measure

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

    Time frame: 3 months

07

Results

Posted Jan 25, 2022

Participant flow

Participant flow — Overall Study
MilestoneAmifostine
Started2
Completed2
Not completed0

Outcome measures

PrimaryIncidence 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
Reported as:
Count of participants · Participants
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
ParticipantsAmifostine
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 Tumors0

Adverse events

Collected over Through 30 days after the end of protocol therapy. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Amifostine0/2 (0%)0/2 (0%)2/2 (100%)
Most frequent other events
Most frequent other events
EventAmifostine
Febrile NeutropeniaBlood and lymphatic system disorders2/2
HypotensionCardiac disorders2/2
MucositisGastrointestinal disorders2/2
NauseaGastrointestinal disorders2/2
VomitingGastrointestinal disorders2/2
HypocalcemiaMetabolism and nutrition disorders2/2
Disease ProgressionGeneral disorders1/2
HypokalemiaMetabolism and nutrition disorders1/2
HypophosphatemiaMetabolism and nutrition disorders1/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Amifostine
<=18 years2
Between 18 and 65 years0
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Amifostine
Female2
Male0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Amifostine
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White2
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Amifostine
United States2
08

Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05167370
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Sponsor
First posted
Dec 22, 2021
Start date
Dec 13, 2010
Primary completion
Apr 29, 2011
Completion
Apr 24, 2012
Results posted
Jan 25, 2022
Last update
Jan 25, 2022

Study contacts

Sonata Jodele, MD
principal investigator · CCHMC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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