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5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT03291990
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : November 6, 2018
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
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 1, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

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



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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
Criteria

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.

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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 ClinicalTrials.gov identifier (NCT number): NCT03291990


Contacts
Contact: Lawrence Kleinberg, MD 410-614-2597 kleinla@jhmi.edu

Locations
United States, District of Columbia
Sibley Hospital Not yet recruiting
Washington, District of Columbia, United States, 20016
Contact: Victoria Croog, MD    202-537-4787    vcroog1@jhmi.edu   
Principal Investigator: Victoria Croog, MD         
Suburban Hospital Not yet recruiting
Washington, District of Columbia, United States, 20818
Contact: Brandi Pge, MD    301-896-2012    bpage5@jhmi.edu   
Principal Investigator: Brandi Page, MD         
United States, Maryland
SKCCC at Johns Hopkins (East Baltimore) Recruiting
Baltimore, Maryland, United States, 21287
Contact: Lawrence Kleinberg, MD    410-614-2597    lkleinb1@jhmi.edu   
Sub-Investigator: Chetan Bettegowda, MD         
Sub-Investigator: Stuart Grossman, MD         
Sub-Investigator: Matthias Holdhoff, MD         
Sub-Investigator: Michael Lim, MD         
Sub-Investigator: Kristin Redmond, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Principal Investigator: Lawrence Kleinberg, MD SKCCC at Johns Hopkins (East Baltimore)

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03291990     History of Changes
Other Study ID Numbers: J1745
IRB00129314 ( Other Identifier: JHMIRB )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents