N/A N=30 Treatment

Neural Progenitor Cell Sparing Radiation Therapy Plus Temozolomide

Glioblastoma Multiforme

Bottom Line

View on ClinicalTrials.gov: NCT01478854 ↗

Enrolled (actual)

Serious AEs

56.7%

Results posted

Jun 2019

Primary outcome: Primary: Number of Participants With Local Recurrence in the Spared NPC Niches — 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Radiation (Radiation); Chemotherapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Local Recurrence in the Spared NPC Niches	—	—
SECONDARY Extent of NPC Sparing	—	—
SECONDARY Distance of Tumor to Spared NPC Niches	—	—
SECONDARY Change in Neurocognitive Function as Measured by Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Subtest	-6.9	—
SECONDARY Change in Neurocognitive Function as Measured by Trail Making Test	20.6; -14.7	—
SECONDARY Change in Neurocognitive Function (Verbal Fluency) as Measured by Controlled Oral Word Association Test (COWAT)	2.6	—
SECONDARY Change in Neurocognitive Function (Total Recall, Delayed Recall, Recognition Discrimination) as Measured by Hopkins Verbal Learning Test-Revised (HVLT-R)	-1.4; -0.6; -0.3	—
SECONDARY Radiation Dose to Spared NPC Region	4906; 1652; 3473; 4181; 1986; 3096	—
SECONDARY Volume (cc) of "NPC for Sparing" Region	—	—

Summary

The long term goal of this research is to establish whether NPC sparing RT techniques improve neurocognitive outcomes compared to conventional RT for brain tumors. If the proposed study demonstrates that NPC sparing RT is not associated with increased LR in the spared regions of the brain compared to conventional RT, it will ideally serve as the foundation for a future multi-institutional randomized controlled trial comparing neurocognitive outcomes in patients treated with NPC-sparing RT versus conventional radiation therapy.

Eligibility Criteria

Inclusion Criteria

Patient must have newly diagnosed Glioblastoma Multiforme (GBM).
Patient must have undergone surgical resection and must begin radiation within 12 weeks of this procedure.
Patients must not have received previous irradiation to the brain.
Patient must be at least 18 years of age
Karnofsky performance status of greater than 60%
Patient must receive temozolomide concurrent with and following radiation.
If a woman is of child-bearing potential, a negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of childbearing potential and men must agree to use adequate contraception for the duration of study participation and for up to 12 weeks following the study. Should a women become pregnant or suspect she is pregnant while participating in this study she should inform her treating physician immediately.
Patient must have the ability to understand and the willingness to sign a written informed consent document.
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria

Patients may not be receiving any other agents to treat their GBM
No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 2 years.
Patients with any other uncontrolled illness will be excluded.
Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. This applies to any woman who has not experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months). Male subjects must also agree to use effective contraception for the same period as above.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01478854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.