Higher radiation dose to the brain's subventricular zone for glioblastoma treatment
A Randomized Phase II Study of Subventricular Zone (SVZ) Irradiation Plus Temozolomide in Newly Diagnosed Glioblastoma Multiforme
This study is testing whether a higher dose of radiation aimed at a specific part of the brain can help people with newly diagnosed glioblastoma live longer without their cancer getting worse compared to standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 3 sites (Washington, District of Columbia and 2 other locations) |
| Trial ID | NCT02177578 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a modified radiation therapy approach combined with temozolomide chemotherapy in patients with newly diagnosed glioblastoma multiforme. Patients will receive six weeks of radiation therapy, with a higher dose specifically targeting the subventricular zone, an area believed to contribute to tumor recurrence. The study aims to compare progression-free survival between those receiving the modified treatment and those receiving standard radiation therapy. The design includes a 3:1 randomization, where three-quarters of participants will receive the experimental treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, histologically confirmed glioblastoma who have undergone surgical resection.
Not a fit: Patients who have previously received radiation therapy to the brain or those with a performance status above 2 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to longer tumor control and improved survival rates for glioblastoma patients.
How similar studies have performed: Previous studies have suggested improved survival with higher radiation doses to the subventricular zone, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient must have newly diagnosed, histologically confirmed GBM. * Patient must have undergone gross total resection, subtotal resection, or biopsy with the extent of resection determined by the treating neurosurgeon, 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 since the diagnosis of GBM in patients younger than 18 is rare and accurate evaluation of neurocognitive function would require a different battery of examinations than employed in this study. * ECOG performance status 0-2 (Karnofsky \>60%; see Appendix A). * Patient must be scheduled to receive temozolomide concurrent with and following radiation (temozolomide may be started late due to insurance reasons, insufficient counts, or other reasons). * 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 (hormonal or barrier method of birth control; abstinence) 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. * Radiation therapy must begin within 12 weeks of surgery. Exclusion Criteria: * No prior malignancy is allowed 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 uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 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. * Use of Avastin or another VEG-F inhibitor prior to progression is not permitted.
Where this trial is running
Washington, District of Columbia and 2 other locations
- Sibley Memorial Hospital — Washington, District of Columbia, United States (Recruiting)
- The SKCCC at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- Suburban Hospital — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Kristin Redmond, M.D. — The SKCCC at Johns Hopkins
- Study coordinator: Kristin Redmond, M.D.
- Email: kjanson3@jhmi.edu
- Phone: 410-614-1642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.