Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

  • STATUS
    Recruiting
  • End date
    Oct 23, 2027
  • participants needed
    68
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 4 October 2022
mycophenolate mofetil
karnofsky performance status
glioblastoma multiforme
temozolomide
gliosarcoma

Summary

This is a phase 0/1 dose-escalation trial to determine the maximum tolerated dose of Mycophenolate Mofetil (MMF) when administered with radiation, in patients with glioblastoma or gliosarcoma.

Description

The goal of the Phase 0 component is to determine if MMF achieves active concentrations in brain tumors. Eight participants in Phase 0 will receive MMF for one week before undergoing an already planned biopsy or re-resection (surgical removal) of glioblastoma or gliosarcoma (GBM/GS). A small portion of the tumor, removed as part of clinical care, will be used for testing in this study. Sixty additional participants will be enrolled in the Phase 1 component of the trial (30 with recurrent GBM/GS and 30 with newly diagnosed GBM/GS). The goal of the Phase 1 component is to find the dose of MMF that works best without causing severe side effects (the maximum tolerated dose) when combined with radiation in recurrent GBM/GS and with radiation and chemotherapy in newly diagnosed GBM/GS. Participants in Phase 0 who meet the eligibility criteria for the Phase 1 component may participate in both phases.

Details
Condition Recurrent Glioblastoma, Recurrent Gliosarcoma, Recurrent Astrocytoma, Grade IV, Newly Diagnosed Glioblastoma, Newly Diagnosed Gliosarcoma, Newly Diagnosed Astrocytoma, Grade IV
Treatment radiation therapy, mycophenolate mofetil, Temozolomide, Re-resection (as part of standard of care)
Clinical Study IdentifierNCT04477200
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Glioblastoma or gliosarcoma (recurrent or newly diagnosed)
Karnofsky Performance Status 60 or greater
Phase 0: Candidate for clinically indicated re-resection or biopsy of glioblastoma or gliosarcoma per treating physician(s)
Phase 1, Recurrent: Candidate for clinically indicated re-irradiation of glioblastoma or gliosarcoma per treating physician(s) (No more than one prior course of radiation for GBM)
Phase 1, Newly Diagnosed: Candidate for upfront standard of care chemoradiation for glioblastoma or gliosarcoma per treating physician(s), to start no earlier than 14 days post- operatively from last definitive surgery for glioblastoma or gliosarcoma (if more than one surgery done. Ex. biopsy prior to resection)
ANC >=1,500 cells/mm^3 within 14 days prior to enrollment
Patient (men and childbearing age women) agrees to the use of highly effective contraception during study participation and for at least 6 weeks for female patients and 90 days for male patients after final MMF administration
Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

Leptomeningeal disease
Known history of HIV
Active hepatitis B or C infection
Lack of histopathological diagnosis of the tumor
Gliomatosis cerebri pattern (tumor involving 3 or more lobes) of disease
Serious intercurrent disease
Use of bevacizumab within 8 weeks of study enrollment
Active systemic or central nervous system (CNS) infection
Grade 4 lymphopenia (if ALC <0.5, patient must be on Pneumocystis jirovecii prophylaxis)
Estimated CrCl < 25 ml/min
History of organ transplantation
Patients with known hypoxanthine-guanine phosphoribosyl-transferase deficiency
History of allergic reaction or hypersensitivity to mycophenolate mofetil or mycophenolic acid or any component of the drug product; or medical contraindication for MMF per treating physician(s)
Known immunosuppressive condition from autoimmune disease, immune deficiency syndrome, or chronic immunosuppressive therapy
Inability to undergo MRI brain with and without contrast
Pregnant or lactating women
Patients with known phenylketonuria
Phase 0: Patients undergoing biopsy who are deemed unlikely to have sufficient tissue to spare for research purposes (e.g., those whose tumors are in an eloquent brain location where all tissue taken must be used for diagnostic purposes)
Phase I: Increase in steroid requirement within 7 days of study enrollment (stable or decreasing dose allowed)
Phase I, Recurrent: Radiation within 6 months prior to study enrollment
Phase I, Recurrent: Surgery within 4 weeks of re-irradiation
Phase I, Newly Diagnosed: History of hypersensitivity reactions to temozolomide or any other ingredients in temozolomide and dacarbazine
Phase I, Newly Diagnosed: Prior chemotherapy or radiation therapy for glioblastoma or gliosarcoma
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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