Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Gliosarcoma

Disease Attributes

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Temozolomide

Mycophenolic Acid

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Enzyme Inhibitors

Mycophenolate mofetil; radiation therapy; temozolomide

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

Mycophenolate Mofetil

Radiation Therapy

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

Re-resection (as part of standard of care)

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.

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

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

Cancer AnswerLine

Nathan Clarke, M.D.

Nathan Clarke, MD

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.

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.

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

Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

Phase 0/I Dose Escalation Study of Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma

The concentration of MPA (the active metabolite of mycophenolate mofetil \[MMF\]) in tumor tissue, measured by mass spectrometry on a continuous scale after one week of MMF administration.

This measure includes all phase 0 participants.

DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + radiation therapy (RT). Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

This measure includes only phase 1 participants with recurrent GBM/GS.

DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + RT + TMZ. Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

This measure includes only newly diagnosed phase 1 participants.

DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced during the first 2 cycles (8 weeks) of MMF with adjuvant TMZ. (The first cycle of MMF with adjuvant TMZ begins 28 days post-RT.) These will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

This measure includes only newly diagnosed phase 1 participants.

The concentrations of GTP in tumor tissue, measured by mass spectrometry on a continuous scale.

This measure includes all phase 0 participants.

Toxicities at each dose level will be tabulated, categorized by grade and attribution.

This measure includes all phase 1 participants.

Toxicities at each dose level will be tabulated, categorized by grade and attribution.

This measure includes only newly diagnosed phase 1 participants.

Determined by modified Response Assessment for Neuro-Oncology (mRANO) criteria. The number and proportion of patients with progressive disease, stable disease, partial and complete response will be calculated for each dose level and overall.

This measure includes only phase 1 participants with recurrent GBM/GS.

PFS defined as time from date of registration to the date of documented progressive disease, other disease related therapy or death. Determined by mRANO criteria.

This measure includes only phase 1 participants with recurrent GBM/GS.

FFLP defined as time from date of registration to the date of documented local progressive disease. Determined by mRANO criteria.

This measure includes only phase 1 participants with recurrent GBM/GS.

OS defined as time from date of registration to date of death or last follow up. Determined by Kaplan Meier method.

This measure includes only phase 1 participants with recurrent GBM/GS.

Spots Global Cancer Trial Database for newly diagnosed gliosarcooma