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5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03291990
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : February 17, 2021
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
This investigation is not only to develop an improved radiation/temozolomide approach, but also develop a regimen with potential to form the basis of better combined therapy with immune based treatments.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Temozolomide Early Phase 1

Detailed Description:
Glioblastoma has a poor prognosis with median survival is 14-16 months for patients enrolling in clinical trials, and across the United States one year survival is reported in the Surveillance, Epidemiology, and End Results (SEER) registry to be only 35%. Radiation treatment related lymphopenia has been associated with poor tumor outcome in Glioblastoma and a variety of other tumor types. As this lymphopenias is prolonged, it may also reduce efficacy of the checkpoint inhibitor lymphocyte mediated immune therapies now approved by the FDA for an increasing number of indications. Modeling and clinical studies suggest that administering radiation over 5 or fewer days (rather than standard 30 days of treatment) may reduce the incidence of lymphopenia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 5 fraction hypofractionated stereotacic radiosurgery along with standard temozolomide
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study to Assess Feasibility of 5 Fraction Hypofractionated Stereotactic Radiosurgery Along With Standard Temozolomide as a Lymphocyte Sparing Therapy for Glioblastoma Multiforme
Actual Study Start Date : October 18, 2017
Actual Primary Completion Date : August 19, 2020
Actual Study Completion Date : August 19, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 5 fraction radiotherapy with standard temozolomide
5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide
Drug: Temozolomide
5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide
Other Name: 5 fraction radiosurgery with temozolomide

Primary Outcome Measures :
  1. Rate of change of lymphopenia [ Time Frame: 10 weeks ]
    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.

Secondary Outcome Measures :
  1. Percentage change in Cluster of differentiation 4 (CD4) count (antigen found on helper T cells) [ Time Frame: 10 weeks ]
    To describe the percent of patients with CD4 count < 200 mm/m3 at the standard week 10 follow-up

  2. Rate of change of lymphocytes [ Time Frame: 10 weeks ]
    Describe recovery of lymphocyte counts during routine clinical follow-up.

  3. Rate of survival [ Time Frame: 10 weeks ]
    To describe clinical/survival outcome based upon routine standard of care.

  4. Rate of change in serious adverse events [ Time Frame: 10 weeks ]
    To describe treatment related serious adverse effects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03291990

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United States, District of Columbia
Sibley Hospital
Washington, District of Columbia, United States, 20016
Suburban Hospital
Washington, District of Columbia, United States, 20818
United States, Maryland
SKCCC at Johns Hopkins (East Baltimore)
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Principal Investigator: Lawrence Kleinberg, MD SKCCC at Johns Hopkins (East Baltimore)
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT03291990    
Other Study ID Numbers: J1745
IRB00129314 ( Other Identifier: JHMIRB )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents