Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01478321 : Efficacy of Hypofractionated XRT w/Bev. + Temozolomide for Recurrent Gliomas
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients must have histologically confirmed diagnosis of glioblastoma multiforme
(GBM) or anaplastic glioma, World Health Organization (WHO) grade 3 or 4

- Patients must have measurable or non-measurable (evaluable) disease recurrence

- Recurrence must be documented based on a combination of clinical and imaging
parameters, consistent with routine clinical practice, with or without
histologic confirmation

- Patients may have had any number of relapses and be eligible for the study

- Patients must have been previously treated with radiation therapy and
temozolomide (bevacizumab-naïve - Groups 1 and 3) or radiation therapy,
temozolomide and bevacizumab (bevacizumab-exposed -Groups 2 and 4); therapy with
these agents may be given together or sequentially in the past

- All patients may have had prior surgery, chemotherapy, and radiation therapy;
prior biologic therapy is permitted only for bevacizumab-exposed patients
(Groups 2 and 4); prior treatment with Gliadel is permitted for all groups

- For bevacizumab-naïve patients (Groups 1 and 3) a minimum of 6 months must have
elapsed since completion of radiation therapy for study entry, and there is no
minimum time since completion of last chemotherapy; for bevacizumab-exposed
patients (Groups 2 and 4) no minimum time since completion of last radiation
therapy, biologic agents, or chemotherapy will be required for study entry

- Patients must have an ECOG performance status of =< 2

- Hemoglobin >= 10

- Platelets >= 100,000/mm^3

- Absolute neutrophil count >= 1500/mm^3

- Bilirubin =< 1.5 x upper limit of normal range (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN

- Blood urea nitrogen (BUN) =< 1.5 x ULN

- Creatinine =< 1.5 x ULN

- Urine protein/creatinine ratio should be =< 1

- Patients' baseline blood pressure must be adequately controlled with or without
antihypertensive medications prior to enrollment (systolic < 140 mmHg, diastolic
< 90 mmHg)

- Patients must have a baseline evaluation including history and physical
examination with neurological evaluation and magnetic resonance imaging (MRI) of
the brain (with and without gadolinium-based contrast), all completed within 30
days prior to initiation of treatment

- Female patients of child-bearing potential must have a negative pregnancy test
within 14 days prior to enrollment on study; child-bearing potential is defined
as any female (regardless of sexual orientation, having undergone a tubal
ligation, or remaining celibate by choice) who meets one of the following
criteria:

- Has not undergone a hysterectomy or bilateral oophorectomy

- Or has not been naturally postmenopausal for at least 12 consecutive months
(i.e. has had menses at any time in the preceding consecutive 12 months)

- Females of child-bearing potential and sexually-active males must consent to
follow acceptable birth control methods to avoid contraception while on
treatment

- All subjects must have given signed, informed consent prior to registration on
study

- Patients previously treated outside of Northwestern must have their pathology
slides sent to Northwestern for review and confirmation - NOTE: a copy of the
pathology report is sufficient for registration

Exclusion Criteria:

- • Patients who are pregnant or breast-feeding will NOT be eligible for participation

• Patients with a prior malignancy will NOT be eligible for participation aside from
the following exception:

- Patients who have had any curatively treated malignancy and have been disease free
without treatment for 1 year prior to study entry ARE eligible for participation

- Patients with an active second malignancy (other than non-melanoma skin cancer
or cervical cancer in situ) are NOT eligible for participation

- Patients with uncontrolled hypertension (>= 140/90 mmHg) are NOT eligible for
participation

- Patients who exhibit any other serious concurrent infection or other medical
illness which would jeopardize their ability to receive the therapy outlined in
this protocol with reasonable safety will NOT be eligible for participation

- The eligibility criteria listed above are interpreted literally and cannot be
waived
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01478321      |      Link to official Clinicaltrials.gov listing
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