- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03291990
5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme
A Pilot Study to Assess Feasibility of 5 Fraction Hypofractionated Stereotactic Radiosurgery Along With Standard Temozolomide as a Lymphocyte Sparing Therapy for Glioblastoma Multiforme
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20016
- Sibley Hospital
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Washington, District of Columbia, United States, 20818
- Suburban Hospital
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Maryland
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Baltimore, Maryland, United States, 21287
- SKCCC at Johns Hopkins (East Baltimore)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must be at least 18 years of age.
- Patients must have confirmed glioblastoma multiforme (GBM)
- Maximum postoperative dimension of cavity plus residual contrast enhancing tumor of < * If a patient is found on the radiation planning scan to have a tumor target larger than this size, the patient will be removed from the study.
- Patient must be selected for standard temozolomide chemotherapy to be administered with radiotherapy.
- Patient agrees to have 10 week follow-up visit at a participating Johns Hopkins facility.
- Patient agrees to allow access to or provide clinical, imaging, and laboratory follow-up information for three years whether or not obtained from Johns Hopkins providers.
3.1.7. Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, Tumor-infiltrating lymphocytes (TIL), Lymphokine-Activated Killer Cell (LAK) or gene therapy), or hormonal therapy for their brain tumor. Glucocorticoid therapy is allowed.
- Patients must have a Karnofsky performance status 60% or higher (i.e. the patient must be able to care for himself/herself with occasional help from others).
- Patients must be able to provide written informed consent.
- Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test.
- Patients must be able to undergo MRI scan with gadolinium contrast for treatment planning.
Exclusion Criteria:
- Patients may not plan to receive any other approved or investigational agents to treat their glioblastoma besides temozolomide prior to the evaluation visit 10 weeks after the initiation of radiotherapy and temozolomide.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 5 fraction radiotherapy with standard temozolomide
5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide
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5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of change of lymphopenia
Time Frame: 10 weeks
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To measure the incidence of > grade 3ymphopenia resulting from combined stereotactic hypofractionated radiotherapy and standard temozolomide in malignant glioma at the the standard follow-up 10 weeks after the initiation of therapy.
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10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage change in Cluster of differentiation 4 (CD4) count (antigen found on helper T cells)
Time Frame: 10 weeks
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To describe the percent of patients with CD4 count < 200 mm/m3 at the standard week 10 follow-up
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10 weeks
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Rate of change of lymphocytes
Time Frame: 10 weeks
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Describe recovery of lymphocyte counts during routine clinical follow-up.
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10 weeks
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Rate of survival
Time Frame: 10 weeks
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To describe clinical/survival outcome based upon routine standard of care.
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10 weeks
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Rate of change in serious adverse events
Time Frame: 10 weeks
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To describe treatment related serious adverse effects
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10 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Lawrence Kleinberg, MD, SKCCC at Johns Hopkins (East Baltimore)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- J1745
- IRB00129314 (Other Identifier: JHMIRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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