Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

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.

Conditions

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

Interventions

DRUG

Mycophenolate Mofetil

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

RADIATION

Radiation Therapy

60 Gy in 30 fractions

DRUG

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)

RADIATION

Radiation Therapy

40.5 Gy in 15 fractions

PROCEDURE

Re-resection (as part of standard of care)

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

DRUG

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.

DRUG

Mycophenolate Mofetil

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Michigan Rogel Cancer Center

  lead OTHER

Principal Investigators

• Nathan Clarke, MD · University of Michigan Rogel Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-05

Primary Completion

2025-01-06

Completion

2027-11-05

FDA Drug

Yes

Countries

• United States

Study Locations