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Testing the Addition of an Anti-Cancer Drug, Mycophenolate Mofetil, to the Usual Treatment (Radiation Therapy and Temozolomide) for Advanced Brain Cancer

ConditionAdvanced Glioblastoma
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlliance for Clinical Trials in Oncology

About this trial

This phase II/III trial tests how well adding mycophenolate mofetil, to the usual treatment with intensity-modulated radiation therapy and temozolomide works for the treatment of glioblastoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Mycophenolate mofetil blocks enzyme activity which can disrupt tumor activity and may make the tumor more sensitive to radiation and/or temozolomide. Intensity modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Temozolomide is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Giving mycophenolate mofetil with intensity-modulated radiation therapy and temozolomide may be more effective than intensity-modulated radiation therapy and temozolomide alone for the treatment of advanced glioblastoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed primary glioblastoma by World Health Organization (WHO) 2021 criteria

No spinal cord glioblastoma

No leptomeningeal disease

No extracranial metastatic disease

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo IMRT

  • Hypofractionated Radiation Therapy

    Radiation

    Undergo hypofractionated radiation therapy

  • Temozolomide (TMZ)

    Drug

    Given PO

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Biospecimen Collection

    Procedure/Surgery

    undergo Biospecimen Collection

  • Mycophenolate Mofetil

    Drug

    Given PO

Treatment groups

422 Participants
are divided into 2 treatment groups
Group A: Arm I (radiation, temozolomide)Experimental treatment 5 interventions
Group B: Arm II (radiation, temozolomide, mycophenolate mofetil)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS) (phase II)

PFS will be calculated from randomization until disease progression according to RANO 2.0 criteria or death due to any cause, censoring patients at their last disease evaluation. The Kaplan-Meier method will be used to estimate PFS for each arm and a stratified log-rank test will be used to compare distributions

Time frame
From randomization to the disease progression according to Response Assessment in Neuro-Oncology (RANO) 2.0 criteria or death due to any cause, up to 5 years
2

Overall survival (OS) (phase III)

OS will be calculated from randomization until death due to any cause, censoring patients at their last disease evaluation. The Kaplan-Meier method will be used to estimate OS for each arm and a stratified log-rank test will be used to compare distributions.

Time frame
From randomization until death due to any cause, up to 5 years

Secondary outcomes

1

Tumor response

Defined as a complete response or partial response as determined using RANO 2.0.

Time frame
Up to 5 years
2

Incidence of adverse events

Determined by the most recent version of Common terminology Criteria for Adverse Events.

Time frame
Up to 5 years
3

Overall survival (OS)

Kaplan Meier methods will be used to estimate key aspects of the OS distributions for each of the treatment arms, and log rank tests will be used to compare these distributions between arms.

Time frame
From randomization until death due to any cause, up to 5 years
4

Progression free survival (PFS)

Kaplan-Meier methods will be used to estimate key aspects of the PFS distributions for each of the treatment arms, and log-rank tests will be used to compare these distributions between arms.

Time frame
From randomization to the disease progression according to RANO 2.0 criteria or death due to any cause, up to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alliance for Clinical Trials in Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: