Trial Outcomes & Findings for Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors (NCT NCT00528437)

Last Updated: 2021-07-08

Results Overview

EFS will be reported in patients with recurrent or refractory medulloblastoma/ primitive neuroectodermal tumors. EFS is defined as the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Day +42

Results posted on

2021-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin. temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid: 13-cis-retinoic acid, when absorbed, may be subject to first-pass metabolism and subsequent plasma (and tumor) concentrations will depend on the rate of metabolism to the inactive 4-oxo metabolite.
Overall Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin. n=46 Participants temozolomide, thiotepa, carboplatin, 13-cis-retinoic acid: 13-cis-retinoic acid, when absorbed, may be subject to first-pass metabolism and subsequent plasma (and tumor) concentrations will depend on the rate of metabolism to the inactive 4-oxo metabolite.
Age, Categorical <=18 years	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: Day +42

Population: Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day +77

Population: Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available

OS will be reported in patients with recurrent or refractory medulloblastoma/ primitive neuroectodermal tumors. OS is defined as the length of time from the start of treatment that patients diagnosed with disease are still alive.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available

To report the toxicity of of 13-cis-retinoic acid following high dose temozolomide, thiotepa and carboplatin with ASCR.

Outcome measures

Outcome data not reported

Adverse Events

Myeloablative Chemo-Temozolomide, Thiotepa, and Carboplatin.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sharon Gardner

NYU Langone

Phone: 212-263-9913

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place