Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT01542736
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 160.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to study the efficacy of the combination of reduced dose craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with concurrent carboplatin and vincristine administration for metastatic classical histology medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Medulloblastoma; High Risk Supratentorial PNET; Metastatic PNET	Drug: Carboplatin; Drug: Vincristine; Radiation: 24 Gy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of Using Concurrent Carboplatin and Reduced Dose Craniospinal Radiation (24Gy) for Metastatic Medulloblastoma, High-Risk Supratentorial PNET and Metastatic PNET
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reduced radiation with concurrent chemotherapy Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration	Drug: Carboplatin; Administered concurrently with craniospinal radiation.; Drug: Vincristine; Administered concurrently with craniospinal radiation.; Radiation: 24 Gy; Craniospinal radiation.

Outcome Measures

Primary Outcome Measures

1. Event-free Survival [Up to 60 months.]

   MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.

2. Overall Survival [up to 5 years]

   Overall Survival will be measured at the end of study. number of surviving participants is reported.

3. Intellectual Competence Measured by IQ Score: Week 8 [Week 8]

   Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.

4. Intellectual Competence Measured by IQ Score: Month 24 [Month 24]

   Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.

5. Intellectual Competence Measured by IQ Score: Month 60 [Month 60]

   Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age greater than 3 years and less than 25 years

• Patients with classic histology or desmoplastic histology metastatic medulloblastoma by histological diagnosis and by head and spine MRI.

• Patients with high-risk supratentorial, non-metastatic, PNET

• Patients with metastatic PNET

• Newly diagnosed patients who have not received prior therapy, with the exception of one short course of emergent chemotherapy in newly presenting patients with neurological compromise per provider decision

• Only patients who are expected to survive at least 6 weeks will be eligible for this study.

Exclusion Criteria:

• Patients who are pregnant may not be treated on this study

• Patients with anaplastic histology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Jennifer Madden, RN, CPNP, University of Colorado, Denver

Study Documents (Full-Text)

• Study Protocol - Aug 7, 2014

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT01542736
• Other Study ID Numbers: 06-1151
• First Posted: Mar 2, 2012
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Medulloblastoma; Neuroectodermal Tumors, Primitive; Carboplatin; Vincristine

Study Results

Participant Flow

Arm/Group Title	Reduced Radiation With Concurrent Chemotherapy
Arm/Group Description	Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Period Title: Overall Study
STARTED	8
COMPLETED	7
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Reduced Radiation With Concurrent Chemotherapy
Arm/Group Description	Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Overall Participants	8
Age (Count of Participants)
<=18 years	7 87.5%
Between 18 and 65 years	1 12.5%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	8.125
Sex: Female, Male (Count of Participants)
Female	4 50%
Male	4 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	8 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 37.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 12.5%
White	4 50%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	8 100%

Outcome Measures

1. Primary Outcome

Title	Event-free Survival
Description	MRIs of the head and spine. Number of participants with event free survival at 60 months is reported.
Time Frame	Up to 60 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reduced Radiation With Concurrent Chemotherapy
Arm/Group Description	Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Measure Participants	8
Count of Participants [Participants]	7 87.5%

2. Primary Outcome

Title	Overall Survival
Description	Overall Survival will be measured at the end of study. number of surviving participants is reported.
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Reduced Radiation With Concurrent Chemotherapy
Arm/Group Description	Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Measure Participants	8
Count of Participants [Participants]	7 87.5%

3. Primary Outcome

Title	Intellectual Competence Measured by IQ Score: Week 8
Description	Neuropsychological testing will be performed after radiation in completed. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Not all participants were feeling well enough to complete testing at this timepoint.

Arm/Group Title	Reduced Radiation With Concurrent Chemotherapy
Arm/Group Description	Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Measure Participants	5
Mean (Full Range) [score on a scale]	102.4

4. Primary Outcome

Title	Intellectual Competence Measured by IQ Score: Month 24
Description	Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Time Frame	Month 24

Outcome Measure Data

Analysis Population Description

Not all participants were feeling well enough to complete testing at this timepoint.

Arm/Group Title	Reduced Radiation With Concurrent Chemotherapy
Arm/Group Description	Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Measure Participants	6
Mean (Full Range) [score on a scale]	96.83

5. Primary Outcome

Title	Intellectual Competence Measured by IQ Score: Month 60
Description	Neuropsychological testing will be performed after radiation in completed. IQ score is reported. The Wechsler Intelligence Scale for Children, 5th edition (WISC-V) measures intellectual competence in Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. The average score for the scale is fixed at 100, with a standard deviation of 15. Higher scores indicate higher levels of intellectual competence and a better outcome.
Time Frame	Month 60

Outcome Measure Data

Analysis Population Description

Not all participants were feeling well enough to complete testing at this timepoint.

Arm/Group Title	Reduced Radiation With Concurrent Chemotherapy
Arm/Group Description	Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
Measure Participants	2
Mean (Full Range) [score on a scale]	79

Adverse Events

Time Frame	Until time of death or progression (Up to 10 years)
Arm/Group Title	Reduced Radiation With Concurrent Chemotherapy
Arm/Group Description	Reduced dose craniospinal radiation with concurrent carboplatin and vincristine administration Carboplatin: Administered concurrently with craniospinal radiation. Vincristine: Administered concurrently with craniospinal radiation. 24 Gy: Craniospinal radiation.
All Cause Mortality
	Reduced Radiation With Concurrent Chemotherapy
	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)
Serious Adverse Events
	Reduced Radiation With Concurrent Chemotherapy
	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)
Infections and infestations
Death due to multi-system organ failure	1/8 (12.5%)	1
Other (Not Including Serious) Adverse Events
	Reduced Radiation With Concurrent Chemotherapy
	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)
Nervous system disorders
Relapse	1/8 (12.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.