Neural Progenitor Cell Sparing Radiation Therapy Plus Temozolomide

NCT01478854 | Completed Results DMC

• 2 other identifiers: J10100NA_00042009
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Local Recurrence in the Spared NPC Niches

  Number of participants with local recurrence (LR) at 1 year in the spared neural progenitor cell (NPC) containing niches of the brain in patients treated with NPC sparing radiation therapy (RT) plus temozolomide for newly diagnosed glioblastoma multiforme (GBM). Local recurrence in spared area is defined as development of a new regions of T1 post gadolinium enhancement.

  1 year

Secondary Outcomes (8)

• Extent of NPC Sparing

  1 year

• Distance of Tumor to Spared NPC Niches

  1 year

• Change in Neurocognitive Function as Measured by Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Subtest

  Change from baseline to 6 months

• Change in Neurocognitive Function as Measured by Trail Making Test

  Change from baseline to 6 months

• Change in Neurocognitive Function (Verbal Fluency) as Measured by Controlled Oral Word Association Test (COWAT)

  Change from baseline to 6 months

Study Arms (1)

Neural Progenitor Cell Sparing Radiation with Temozolomide

EXPERIMENTAL

All subjects are treated with neural progenitor cell sparing radiation to 60 Gy in 2 Gy per day, 30 fractions Concurrent and adjuvant temozolomide chemotherapy

Radiation: Radiation; Drug: Chemotherapy

Interventions

Radiation RADIATION

Patients will be treated to a total dose of 60 Gy with a once daily fractionation schedule of 2 Gy per fraction, administered five days per week. All patients will undergo CT simulation with intravenous contrast. In addition they will undergo MRI simulation with both T1 with gadolinium as well as FLAIR sequences. They will be treated in a supine position using an aquaplast mask system for immobilization. CT image data will be reconstructed in approximately 3 mm slice thickness and manually coregistered with T1 post-gadolinium and FLAIR sequence MRI.

Neural Progenitor Cell Sparing Radiation with Temozolomide

Chemotherapy DRUG

Temozolomide

Neural Progenitor Cell Sparing Radiation with Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiation; Drug Therapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Physical Phenomena; Therapeutics

Results Point of Contact

• Title: Kristin Redmond, MD
• Organization: Johns Hopkins University School of Medicine

kjanson3@jhmi.edu

410-955-6980

Study Officials

• Kristin Redmond, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 23, 2011
• Study Start: December 27, 2011
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: June 13, 2019
• Results First Posted: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)