5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme

NCT03291990 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: J1745IRB00129314
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Rate of change of lymphopenia

  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.

  10 weeks

Secondary Outcomes (4)

• Percentage change in Cluster of differentiation 4 (CD4) count (antigen found on helper T cells)

  10 weeks

• Rate of change of lymphocytes

  10 weeks

• Rate of survival

  10 weeks

• Rate of change in serious adverse events

  10 weeks

Study Arms (1)

5 fraction radiotherapy with standard temozolomide

EXPERIMENTAL

5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide

Drug: Temozolomide

Interventions

Temozolomide DRUG

5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide

Also known as: 5 fraction radiosurgery with temozolomide

5 fraction radiotherapy with standard temozolomide

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (3)

Sibley Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Suburban Hospital

Washington D.C., District of Columbia, 20818, United States

Location

SKCCC at Johns Hopkins (East Baltimore)

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

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)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lawrence Kleinberg, MD

  SKCCC at Johns Hopkins (East Baltimore)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 5 fraction hypofractionated stereotacic radiosurgery along with standard temozolomide

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 25, 2017
• Study Start: October 18, 2017
• Primary Completion: August 19, 2020
• Study Completion: August 19, 2020
• Last Updated: November 19, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)