Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2027-11-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Recurrent Glioblastoma Recurrent Gliosarcoma Recurrent Astrocytoma, Grade IV Newly Diagnosed Glioblastoma Newly Diagnosed Gliosarcoma Newly Diagnosed Astrocytoma, Grade IV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Phase 0 will include 8 participants; eligible participants from phase 0 may continue on to phase 1.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)

Mycophenolate mofetil

Group Type EXPERIMENTAL

Mycophenolate Mofetil

Intervention Type DRUG

500-2000mg orally twice daily, one week prior to re-resection (2 participants at each of 4 dose levels: 500mg, 1000mg, 1500mg and 2000mg)

Re-resection (as part of standard of care)

Intervention Type PROCEDURE

Re-resection or biopsy of tumor as part of standard of care

Phase 1 - Recurrent GBM / GS

Mycophenolate mofetil; radiation therapy

Group Type EXPERIMENTAL

Radiation Therapy

Intervention Type RADIATION

40.5 Gy in 15 fractions

Mycophenolate Mofetil

Intervention Type DRUG

250-2000mg orally twice daily, one week prior to and concurrent with RT.

Phase 1 - Newly Diagnosed GBM / GS

Mycophenolate mofetil; radiation therapy; temozolomide

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.

Mycophenolate Mofetil

Intervention Type DRUG

250-2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.

Radiation Therapy

Intervention Type RADIATION

60 Gy in 30 fractions

Interventions

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Mycophenolate Mofetil

500-2000mg orally twice daily, one week prior to re-resection (2 participants at each of 4 dose levels: 500mg, 1000mg, 1500mg and 2000mg)

Intervention Type DRUG

Radiation Therapy

40.5 Gy in 15 fractions

Intervention Type RADIATION

Re-resection (as part of standard of care)

Re-resection or biopsy of tumor as part of standard of care

Intervention Type PROCEDURE

Temozolomide

Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.

Intervention Type DRUG

Mycophenolate Mofetil

250-2000mg orally twice daily, one week prior to and concurrent with RT.

Intervention Type DRUG

Mycophenolate Mofetil

250-2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.

Intervention Type DRUG

Radiation Therapy

60 Gy in 30 fractions

Intervention Type RADIATION

Other Intervention Names

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MMF RT TMZ MMF MMF RT

Eligibility Criteria

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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

* Lack of histopathological diagnosis of the tumor.
* Gliomatosis cerebri pattern (tumor involving 3 or more lobes) of disease.
* Leptomeningeal disease.
* Use of bevacizumab within 8 weeks of study enrollment.
* Known history of HIV.
* Active hepatitis B or C infection.
* 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.
* Serious intercurrent disease.
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No