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|NCT02717962 : Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Recurrent Glioblastoma|
|Ages||Min: 18 Years Max: N/A|
- Patient must willingly provide written consent after being informed of the procedure
to be followed, the experimental nature of the therapy, alternatives, potential
benefits, side effects, risks, and discomforts.
- Patients must be = 18 years old.
- Patients must have histologically confirmed initial diagnosis of primary intracranial
World Health Organization (WHO) Grade IV malignant glioma (glioblastoma, GBM), now
recurrent. Patients with recurrent disease whose initial diagnostic pathology
confirmed glioblastoma will not need re-biopsy. Alternately, patients with prior
intracranial low-grade glioma or anaplastic glioma will be eligible, if histologic
assessment demonstrates transformation to GBM (first diagnosis of secondary GBM).
- Patients must have radiographic evidence of recurrent/progressive GBM after prior
therapy (biopsy or resection and chemoradiation); 1st recurrence of GBM only, per
Response Assessment in Neuro-Oncology Criteria (RANO) criteria. Histologically
documented transformation from a lower grade gliomas will be considered first
- Patients must have confirmed GBM MGMT status (tumor must be MGMT promoter
unmethylated) by central laboratory Clinical Laboratory Improvement Amendments (CLIA)
certified testing at MD Anderson, prior to registration. If initial MGMT testing
obtained at an outside institution, MGMT status must be centrally retested at MD
- Patients must have Karnofsky Performance Status (KPS) > 60% (i.e., 70, 80, 90 or 100).
- Patients must have been previously treated for GBM with radiation with concurrent and
adjuvant temozolomide chemotherapy.
- Adequate recovery from all recent surgery is required. At least 21-days must have
elapsed from the time of any major surgery, including craniotomy/tumor resection.
Patients must have recovered from all surgery-related toxicities to Grade 1 or less.
- Patients must = 12 weeks from radiotherapy, to minimize the potential for magnetic
resonance imaging (MRI) changes related to treatment (pseudo progression) that might
be misdiagnosed as true progression of disease, unless the patient fulfills criteria
for early progressive disease by RANO.
- Prior therapy with gamma knife or other focal high-dose radiation is allowed, but at
least 2 weeks must have elapsed from the time of treatment, and the patient must have
subsequent histologic documentation of recurrence, unless the recurrence is a new
lesion outside the irradiated field.
- Patients having prior therapy with Laser Induced Thermal Therapy (LITT) is allowed,
but at least 21 days must have elapsed from last LITT, with recovery from all
LITT-related toxicities to Grade 1 or less and subsequent histologic documentation of
- Patients must be at least 4 weeks from last dose of chemotherapy.
- Patients must be at least 4 weeks or 5 half-lives (whichever is shorter) from the last
dose of prior investigational anti-cancer drugs.
- Patients must have recovered from all treatment-related toxicities to Grade 1 or less.
- If receiving corticosteroids, patients must be on a stable or decreasing dose of
corticosteroids for = 5 days prior to baseline MRI.
- Patients must have a predicted life expectancy of at least 12 weeks.
- Patients must have adequate bone marrow and organ function.
- Patients must be willing and able to comply with scheduled visits, treatment plan, and
laboratory tests and accessible for follow-up.
- If the patient has been using the Optune™ device, it will be discontinued before
initiating treatment with either study medication, and per inclusion criterion listed
above, the patient must have recovered from all treatment-related toxicities to Grade
1 or less.
- Pregnancy restrictions - Women of childbearing potential must have a negative B-HCG
documented within 7 days prior to registration
- Within 12 weeks of chemoradiation unless the patient fulfills criteria for early
progressive disease by RANO
- Receipt of investigational agents within 5 half-lives of last dose of investigational
- Concurrent use of other investigational agents or Optune™ device
- Prior therapy with lomustine
- Prior therapy with bevacizumab
- Current history of neoplasm other than the entry diagnosis. Patients with previous
cancers treated and cured with local therapy alone may be considered with approval of
- Evidence of leptomeningeal spread of disease
- Need for urgent palliative intervention (e.g., impending herniation)
- Severe, intercurrent illness including, but not limited to unstable systemic disease,
including ongoing or active infection, uncontrolled hypertension, serious cardiac
arrhythmia requiring medication, or psychiatric illness/social situations that would
limit compliance with study requirements
- Patients with a known sensitivity to any of the products to be administered during
- Patients unable to undergo MRI of the brain
- Women who are pregnant or lactating. Women of childbearing potential must have a
negative serum or urine pregnancy test performed within 7 days prior to start of
treatment. Women of childbearing potential or men with partners of childbearing
potential must use effective birth control measures during treatment.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02717962
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