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Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma

Primary Purpose

Astrocytoma, Glioblastoma, Glioblastoma, IDH-Wildtype

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mycophenolate Mofetil
Quality-of-Life Assessment
Radiation Therapy
Temozolomide
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • GROUPS 1-3: Histologically confirmed glioblastoma (GBM), IDH wild-type (by immunohistochemistry [IHC] R132H negative [neg] or sequencing). Astrocytoma with molecular features of GBM are eligible.
  • GROUPS 1-3: Newly diagnosed glioblastoma and:

    • Group 1: Received surgical resection or biopsy followed by chemoradiation;
    • Group 2: Received surgical resection or biopsy only and have documented unmethylated glioblastoma (may have been done at an outside facility);
    • Group 3: Received surgical resection or biopsy only
  • GROUP S: Newly suspected glioblastoma or recurrent glioblastoma, and scheduled to undergo a standard of care surgical resection or biopsy.
  • Stable or decreasing dose of corticosteroids equivalent to =< 8 mg dexamethasone daily, for >= 7 days prior to registration.

    • Note: There are no restrictions on steroid use on study
  • Patients must be age >= 18 years.
  • Patients must exhibit a Karnofsky performance status >= 70.
  • Leukocytes (white blood cells [WBC]) >= 3,000/mcL (within 14 days prior to study registration)
  • Absolute neutrophil count (ANC) >= 1,500/mcL (within 14 days prior to study registration)
  • Hemoglobin (Hgb) >= 8 g/dL (within 14 days prior to study registration) (transfusion may be used for eligibility if >= 7 days)
  • Platelets (PLT) >= 100,000/mcL (within 14 days prior to study registration) (transfusion or growth factor may be used for eligibility if >= 7 days).
  • Total bilirubin =< 2x institutional upper limit of normal (ULN) (within 14 days prior to study registration)
  • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/Alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (within 14 days prior to study registration)
  • Creatinine =< 1.5 x Institutional ULN (within 14 days prior to study registration)
  • International normalized ratio (INR) =< 1.5 x ULN (within 14 days prior to study registration)
  • Prothrombin time (PT)/Partial thromboplastin Time (PTT) =< 1.5 x ULN (within 14 days prior to study registration)
  • Females of child-bearing potential (FOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 3 months following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception from time of informed consent, for the duration of study participation, and 4 months after completion of administration.

    • NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

      • Has not undergone a hysterectomy or bilateral oophorectomy
      • Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
  • FOCBP must have a negative pregnancy test within 14 days prior to registration on study.
  • Patient or their legally authorized representative must provide written, signed, and dated informed consent prior to study registration. Patient or their legally authorized representative (LAR) must have the ability to understand and the willingness to sign a written informed consent document. The patient or their LAR must be willing and able to comply with the protocol for the duration of the study.

    • NOTE: no study-specific screening procedures may be performed until written consent has been obtained.

Exclusion Criteria:

  • Patients who are receiving any other investigational agents.

    • Exception: COVID-19 vaccine and treatment is allowed
  • Patient who have a prior or concurrent malignancy that may interfere with study treatment or safety.

    • NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible. Per principal investigator (PI) discretion
  • Patients who have a history of allergic reactions attributed to compounds of similar chemical composition to temozolomide or mycophenolate mofetil.
  • Patients with spinal cord and diffuse leptomeningeal disease GBM
  • Patients requiring live vaccinations within 2 weeks of initiation of MMF and/or TMZ therapy. Consider completion of vaccination with live vaccines prior to starting immunosuppressive therapy, as indicated.
  • Patients on viral-vector based therapy due to increased risk for disseminated herpetic infection.
  • Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:

    • Have uncontrolled epilepsy
    • Have an uncontrolled intercurrent illness
    • Concurrent malignancy (outside of glioblastoma) that requires tumor directed treatment
    • Known deficiency of hypoxanthine-guanin-phosphoribosyltransferase (HGPRT) deficiency, e.g. Lesch-Nyhan- oder Kelley-Seegmiller-Syndrome.
    • Known concurrent shingles, herpes, CMV (cytomegalovirus) infection
    • Known concurrent opportunistic fungal infection
    • Known concurrent or history of unexplained opportunistic infection
    • Known immunodeficiency that could lead to opportunistic infections
    • Psychiatric illness/social situations that would limit compliance with study requirements. Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.
  • Female patients who are pregnant or nursing. Pregnant women are excluded from this study because temozolomide is an alkylating agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with temozolomide, breastfeeding should be discontinued if the mother is treated with temozolomide.
  • Patients who are unable to swallow oral medication or have problems/ diseases that affect absorption of oral medication.
  • Patients with a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV).

    • Note: Temozolomide and mycophenolate mofetil are immunosuppressive agents. Patients with a known history of HIV, HBV, and HCV, and unexplained opportunistic infections are not eligible due to safety reasons

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1 (TMZ, MMF)

Group 2 (TMZ, MMF, radiation therapy)

Group 3 (TMZ, MMF, radiation therapy)

Group S (pre-surgical MMF, TMZ)

Arm Description

Patients who have already undergone surgery or biopsy followed by chemoradiation receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients with unmethylated glioblastoma who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks.

Patients who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks.

Patients planning to undergo surgery receive MMF PO BID and TMZ PO QD for 5 days prior to surgery in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) for mycophenolate mofetil (MMF) (Group 1)
Will be based on treatment-emergent and drug related toxicity of grade >= 3 during the first cycle of treatment. MTD indicates maximum tolerated dose for dose limiting toxicity (DLT). DLT is defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. Recommended phase 2 dose (RP2D) is the highest dose of a drug or treatment that does not cause unacceptable side effects. For the purposes of this study, RP2D is interchangeable with MTD. DLTs and Adverse Events (AEs) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v). 5.0.
MTD/RP2D for MMF (Group 2)
Will be based on treatment-emergent and drug related toxicity of grade >= 3 during focal radiation treatment. MTD indicates maximum tolerated dose for DLT. DLT is defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. RP2D is the highest dose of a drug or treatment that does not cause unacceptable side effects. For the purposes of this study, RP2D is interchangeable with MTD. DLTs and AEs will be assessed by CTCAE v.5.0.

Secondary Outcome Measures

Frequency of adverse events
The occurrence of toxicity (including [AEs] and serious adverse events [SAEs]), and the number of patients who discontinue treatment due to toxicity, as assessed by CTCAE v. 5.0. This endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution to MMF, according the National Cancer Institute (NCI)-CTCAE v. 5.0.
Progression Free Survival (PFS)
Progression will be determined by clinical progression or by radiographic imaging as assessed by Response Assessment in Neuro-Oncology Criteria (RANO). If disease progression or death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the PFS will be censored as the last available disease assessment. Kaplan-Meier curves will be plot. Log-rank test will be used to compare it with historical standard care control in literature.
Overall survival (OS)
If death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the OS will be censored as the last available follow-up. will be described by Kaplan-Meier curve. The median and corresponding 95% confidence interval will also be estimated.
Overall response rate (ORR)
Overall response rate will be assessed by RANO criteria. To determine the ORR, this endpoint will calculate the proportion of treated patients who experience an overall response (complete response [CR] or partial response [PR] per RANO criteria). The date of first response for either CR or PR will be used for the calculation of ORR. Will be estimated using the expansion cohort, along with its 95% confidence interval.
Quality of life (QOL)
The quality of life indicated by FACT-Br will be evaluated by estimating its mean, standard deviation and 95% confidence interval using the expansion cohort. Patients who received at least 1 dose of temozolomide (TMZ) and/or MMF, and completed at least baseline and cycle 2 day 1 (C2D1) FACT-Br QOL (for Groups 1-3) will be evaluable for this secondary endpoint.

Full Information

First Posted
February 2, 2022
Last Updated
August 22, 2022
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05236036
Brief Title
Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma
Official Title
A Phase 1/1b Adaptive Dose Escalation Study of Mycophenolate Mofetil (MMF) in Combination With Standard of Care for Patients With Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
January 3, 2025 (Anticipated)
Study Completion Date
January 3, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I/Ib trial tests the safety, side effects, and best dose of mycophenolate mofetil in combination with temozolomide and/or radiation therapy (standard of care) in treating patients with glioblastoma. Mycophenolate mofetil is an immunosuppressant drug that is typically used to prevent organ rejection in transplant recipients. However, mycophenolate mofetil may also help chemotherapy with temozolomide work better by making tumor cells more sensitive to the drug. The purpose of this trial is to determine if mycophenolate mofetil combined with temozolomide can stop glioblastoma.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the recommended phase 2 dose (RP2D) for mycophenolate mofetil (MMF) in combination with radiation therapy as well as in combination with temozolomide (TMZ). SECONDARY OBJECTIVES: I. To evaluate the safety profile of mycophenolate mofetil (MMF) in combination with temozolomide (TMZ). II. To estimate progression free survival (PFS) per Response Assessment in Neuro-Oncology Criteria (RANO). III. To estimate overall survival (OS). IV. To estimate the overall response rate (ORR) per RANO criteria. V. To evaluate quality of life per Functional Assessment of Cancer Therapy Scale-Brain (FACT-Br) for patients treated with mycophenolate mofetil and/or temozolomide. EXPLORATORY OBJECTIVES: I. To investigate the relationship between the molecular signature of individual glioblastoma multiforme (GBM) with clinical outcome, by measuring levels of serum mycophenolic acid in patient's plasma post MMF administration. Ia. Perform molecular characterization of all GBM tissues by ribonucleic acid sequencing (RNAseq) analysis. Ib. Perform bulk metabolomics for GBM tissue. Ic. Measure plasma and serum concentration of mycophenolic acid, the MMF's primary active metabolite, during and after combination therapy. Id. Measure IMPDH activity assay in patients' peripheral blood mononuclear cells (PBMCs) as well as in GBM tissue. OUTLINE: This is a dose-escalation study of MMF (Part 1), followed by a dose-expansion study (Part 2). PART 1: Patients are assigned to 1 of 3 groups. GROUP 1: Patients who have already undergone surgery or biopsy followed by chemoradiation receive TMZ orally (PO) once daily (QD) on days 1-5 of each cycle and MMF PO twice daily (BID). Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP 2: Patients with unmethylated glioblastoma who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks. GROUP S: Patients planning to undergo surgery receive MMF PO BID and TMZ PO QD for 5 days prior to surgery in the absence of disease progression or unacceptable toxicity. PART 2: Patients are assigned to Group 3. GROUP 3: Patients who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks. After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astrocytoma, Glioblastoma, Glioblastoma, IDH-Wildtype, MGMT-Unmethylated Glioblastoma, Recurrent Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (TMZ, MMF)
Arm Type
Experimental
Arm Description
Patients who have already undergone surgery or biopsy followed by chemoradiation receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Arm Title
Group 2 (TMZ, MMF, radiation therapy)
Arm Type
Experimental
Arm Description
Patients with unmethylated glioblastoma who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks.
Arm Title
Group 3 (TMZ, MMF, radiation therapy)
Arm Type
Experimental
Arm Description
Patients who have already undergone surgery or biopsy receive TMZ PO QD on days 1-5 of each cycle and MMF PO BID. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting at the same time as TMZ and MMF administration, patients also receive radiation therapy daily, 5 days per week, for 6 weeks.
Arm Title
Group S (pre-surgical MMF, TMZ)
Arm Type
Experimental
Arm Description
Patients planning to undergo surgery receive MMF PO BID and TMZ PO QD for 5 days prior to surgery in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Other Intervention Name(s)
CellCept, MMF
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Receive radiation therapy
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ
Intervention Description
Given Orally (PO)
Primary Outcome Measure Information:
Title
Maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) for mycophenolate mofetil (MMF) (Group 1)
Description
Will be based on treatment-emergent and drug related toxicity of grade >= 3 during the first cycle of treatment. MTD indicates maximum tolerated dose for dose limiting toxicity (DLT). DLT is defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. Recommended phase 2 dose (RP2D) is the highest dose of a drug or treatment that does not cause unacceptable side effects. For the purposes of this study, RP2D is interchangeable with MTD. DLTs and Adverse Events (AEs) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v). 5.0.
Time Frame
Up to completion of first cycle of treatment + 7 days (1 cycle = 28 days)
Title
MTD/RP2D for MMF (Group 2)
Description
Will be based on treatment-emergent and drug related toxicity of grade >= 3 during focal radiation treatment. MTD indicates maximum tolerated dose for DLT. DLT is defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. RP2D is the highest dose of a drug or treatment that does not cause unacceptable side effects. For the purposes of this study, RP2D is interchangeable with MTD. DLTs and AEs will be assessed by CTCAE v.5.0.
Time Frame
Up to 6 weeks + 7 days
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Description
The occurrence of toxicity (including [AEs] and serious adverse events [SAEs]), and the number of patients who discontinue treatment due to toxicity, as assessed by CTCAE v. 5.0. This endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution to MMF, according the National Cancer Institute (NCI)-CTCAE v. 5.0.
Time Frame
Up to 30 days after completion of study treatment
Title
Progression Free Survival (PFS)
Description
Progression will be determined by clinical progression or by radiographic imaging as assessed by Response Assessment in Neuro-Oncology Criteria (RANO). If disease progression or death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the PFS will be censored as the last available disease assessment. Kaplan-Meier curves will be plot. Log-rank test will be used to compare it with historical standard care control in literature.
Time Frame
From baseline until the patient experiences disease progression, initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever is sooner), assessed up to 18 months
Title
Overall survival (OS)
Description
If death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the OS will be censored as the last available follow-up. will be described by Kaplan-Meier curve. The median and corresponding 95% confidence interval will also be estimated.
Time Frame
From time of diagnosis until the patient initiates subsequent anti-cancer therapy, completes study participation, or experiences death from any cause (whichever is sooner), assessed up to 18 months
Title
Overall response rate (ORR)
Description
Overall response rate will be assessed by RANO criteria. To determine the ORR, this endpoint will calculate the proportion of treated patients who experience an overall response (complete response [CR] or partial response [PR] per RANO criteria). The date of first response for either CR or PR will be used for the calculation of ORR. Will be estimated using the expansion cohort, along with its 95% confidence interval.
Time Frame
From baseline, the patient experiences disease progression, the patient initiates subsequent anti-cancer therapy, or the patient completes study participation (whichever occurs first), assessed up to 18 months
Title
Quality of life (QOL)
Description
The quality of life indicated by FACT-Br will be evaluated by estimating its mean, standard deviation and 95% confidence interval using the expansion cohort. Patients who received at least 1 dose of temozolomide (TMZ) and/or MMF, and completed at least baseline and cycle 2 day 1 (C2D1) FACT-Br QOL (for Groups 1-3) will be evaluable for this secondary endpoint.
Time Frame
Up to 6 cycles (1 cycle = 28 days)
Other Pre-specified Outcome Measures:
Title
Mycophenolic acid levels
Description
Will measure in patients' plasma by using the Food and Drug Administration (FDA)-approved protocol Analytical Chemistry Division at the Illinois Institute of Technology Research Institute.
Time Frame
Days 1, 3 and 7 post-MMF administration for cycles 1 and 2
Title
XMP concentration
Description
Will utilize an established clinical protocol and a highly sensitive liquid chromatography-mass spectrometry method in peripheral blood mononuclear cells (PBMCs) isolated from glioblastoma patients receiving MMF in combination with TMZ in order to determine IMPDH activity. This is a clinically validated protocol in which the analytical methods yielded acceptable within samples and within individual variability. Peripheral blood samples taken at baseline and day 1 of each adjuvant TMZ+MMF cycle will be used to test this.
Time Frame
Up to 6 cycles (1 cycle = 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: GROUPS 1-3: Histologically confirmed glioblastoma (GBM), IDH wild-type (by immunohistochemistry [IHC] R132H negative [neg] or sequencing). Astrocytoma with molecular features of GBM are eligible. GROUPS 1-3: Newly diagnosed glioblastoma and: Group 1: Received surgical resection or biopsy followed by chemoradiation; Group 2: Received surgical resection or biopsy only and have documented unmethylated glioblastoma (may have been done at an outside facility); Group 3: Received surgical resection or biopsy only GROUP S: Newly suspected glioblastoma or recurrent glioblastoma, and scheduled to undergo a standard of care surgical resection or biopsy. Stable or decreasing dose of corticosteroids equivalent to =< 8 mg dexamethasone daily, for >= 7 days prior to registration. Note: There are no restrictions on steroid use on study Patients must be age >= 18 years. Patients must exhibit a Karnofsky performance status >= 70. Leukocytes (white blood cells [WBC]) >= 3,000/mcL (within 14 days prior to study registration) Absolute neutrophil count (ANC) >= 1,500/mcL (within 14 days prior to study registration) Hemoglobin (Hgb) >= 8 g/dL (within 14 days prior to study registration) (transfusion may be used for eligibility if >= 7 days) Platelets (PLT) >= 100,000/mcL (within 14 days prior to study registration) (transfusion or growth factor may be used for eligibility if >= 7 days). Total bilirubin =< 2x institutional upper limit of normal (ULN) (within 14 days prior to study registration) Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/Alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (within 14 days prior to study registration) Creatinine =< 1.5 x Institutional ULN (within 14 days prior to study registration) International normalized ratio (INR) =< 1.5 x ULN (within 14 days prior to study registration) Prothrombin time (PT)/Partial thromboplastin Time (PTT) =< 1.5 x ULN (within 14 days prior to study registration) Females of child-bearing potential (FOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 3 months following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception from time of informed consent, for the duration of study participation, and 4 months after completion of administration. NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months) FOCBP must have a negative pregnancy test within 14 days prior to registration on study. Patient or their legally authorized representative must provide written, signed, and dated informed consent prior to study registration. Patient or their legally authorized representative (LAR) must have the ability to understand and the willingness to sign a written informed consent document. The patient or their LAR must be willing and able to comply with the protocol for the duration of the study. NOTE: no study-specific screening procedures may be performed until written consent has been obtained. Exclusion Criteria: Patients who are receiving any other investigational agents. Exception: COVID-19 vaccine and treatment is allowed Patient who have a prior or concurrent malignancy that may interfere with study treatment or safety. NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible. Per principal investigator (PI) discretion Patients who have a history of allergic reactions attributed to compounds of similar chemical composition to temozolomide or mycophenolate mofetil. Patients with spinal cord and diffuse leptomeningeal disease GBM Patients requiring live vaccinations within 2 weeks of initiation of MMF and/or TMZ therapy. Consider completion of vaccination with live vaccines prior to starting immunosuppressive therapy, as indicated. Patients on viral-vector based therapy due to increased risk for disseminated herpetic infection. Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible: Have uncontrolled epilepsy Have an uncontrolled intercurrent illness Concurrent malignancy (outside of glioblastoma) that requires tumor directed treatment Known deficiency of hypoxanthine-guanin-phosphoribosyltransferase (HGPRT) deficiency, e.g. Lesch-Nyhan- oder Kelley-Seegmiller-Syndrome. Known concurrent shingles, herpes, CMV (cytomegalovirus) infection Known concurrent opportunistic fungal infection Known concurrent or history of unexplained opportunistic infection Known immunodeficiency that could lead to opportunistic infections Psychiatric illness/social situations that would limit compliance with study requirements. Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints. Female patients who are pregnant or nursing. Pregnant women are excluded from this study because temozolomide is an alkylating agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with temozolomide, breastfeeding should be discontinued if the mother is treated with temozolomide. Patients who are unable to swallow oral medication or have problems/ diseases that affect absorption of oral medication. Patients with a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV). Note: Temozolomide and mycophenolate mofetil are immunosuppressive agents. Patients with a known history of HIV, HBV, and HCV, and unexplained opportunistic infections are not eligible due to safety reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
3126951301
Email
cancer@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priya U Kumthekar, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priya U. Kumthekar, MD
Phone
312-503-1818
Email
p-kumthekar@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Priya U. Kumthekar, MD

12. IPD Sharing Statement

Learn more about this trial

Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma

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