Trial Outcomes & Findings for High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors (NCT NCT05167370)

Last Updated: 2022-01-25

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

3 months

Results posted on

2022-01-25

Participant milestones
Measure	Amifostine 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.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Amifostine n=2 Participants 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.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

Timeframe: 3 months

Outcome measures
Measure	Amifostine n=2 Participants 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.
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	0 Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Amifostine n=2 participants at risk 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.
Blood and lymphatic system disorders Febrile Neutropenia	100.0% 2/2 • Number of events 2 • Through 30 days after the end of protocol therapy
Cardiac disorders Hypotension	100.0% 2/2 • Number of events 2 • Through 30 days after the end of protocol therapy
Gastrointestinal disorders Mucositis	100.0% 2/2 • Number of events 2 • Through 30 days after the end of protocol therapy
Gastrointestinal disorders Nausea	100.0% 2/2 • Number of events 2 • Through 30 days after the end of protocol therapy
Gastrointestinal disorders Vomiting	100.0% 2/2 • Number of events 2 • Through 30 days after the end of protocol therapy
General disorders Disease Progression	50.0% 1/2 • Number of events 1 • Through 30 days after the end of protocol therapy
Metabolism and nutrition disorders Hypocalcemia	100.0% 2/2 • Number of events 2 • Through 30 days after the end of protocol therapy
Metabolism and nutrition disorders Hypokalemia	50.0% 1/2 • Number of events 1 • Through 30 days after the end of protocol therapy
Metabolism and nutrition disorders Hypophosphatemia	50.0% 1/2 • Number of events 1 • Through 30 days after the end of protocol therapy

Cincinnati Children's Hospital Medical Center

Phone: (513) 636-5917