Clinical Trial Details
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NCT02433392 : Study of Intraparenchymal Therapy as Adjunct Therapy in Patients With Recurrent, Surgically Resectable Glioblastoma Multiforme.
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. histologically confirmed diagnosis of Glioblastoma Multiforme (GBM) (World Health
Organization grade IV)

2. recurrent disease

3. patient will be considered a good candidate for resection and will have estimated
life expectancy of at least 12 weeks as estimated by the Principal Investigator or
designee. The decision to opt for resection of the recurrence must be independent of
study selection.

4. Tumour characteristics:

- Single unilateral and supratentorial lesion

- On clinician's assessment, must be operable under normal considerations of risk
vs. benefit for condition and prognosis

5. patient will have received conventional treatment at the time of initial diagnosis,
including surgery (biopsy or de-bulking), and/or radiotherapy, and/or chemotherapy

6. male or female; no racial exclusions; at least 18 years of age

7. Pregnancy must be excluded in female patients by beta- HCG (Human Chorionic
Gonadotropin); all patients agree to use adequate contraception for study duration

8. Karnofsky Performance Status of at least 60

9. Patients must be able to understand consent and study instructions as well as follow
prescribed instructions

10. patient must have signed written informed consent prior to study participation

Exclusion Criteria:

1. patient must not be enrolled in any other clinical trial for 30 days before or after
participation in this trial

2. history of allergic reactions attributed to compounds of similar chemical make-up or
composition to CM-BC2, alginate or irinotecan; or has any other contraindications to
irinotecan therapy

3. open communication between the ventricle CSF (cerebrospinal fluid) and tumour
resection cavity/site must be avoided. In the case of opening ventricles during
surgery, the surgeon must decide whether effective closure is possible by obstructing
the gap with Gelfoam/other appropriate materials

4. Tumor surgery, other than stereotactic biopsy of the GBM, or other neurosurgery
within 30 days prior to study entry

5. Multiple GBM lesions

6. Irinotecan chemotherapy within 30 days prior to study treatment

7. radiotherapy or stereotactic (gamma knife) radiosurgery within 90 days prior to study

8. loco-regional (intra-cranial) therapy for the treatment of GBM, including
administration of biodegradable polymer wafers containing Carmustine and/or
brachytherapy, in the 6 months prior to study entry

9. Significant liver function impairment: aminotransferase (AST) or alanine transaminase
(ALT) greater than 2.5 x the upper limit of normal (ULN), or total bilirubin greater
than 2 x ULN

10. significant renal impairment: creatinine greater than 2.0 mg/dL

11. Coagulopathy Prothrombin time (PT) or partial thromboplastin time (APTT) of less than
1.5 x control, and/or platelet count of less than 100 x 10?/L

12. Hb less than 8 g/dL and/or neutrophil count (ANC - Absolute Neutrophil Count) of less
than 1 x 10?/L

13. Any condition that, in the investigator's opinion, makes it in the patient's best
interest not to participate in the study

14. Pre-existing cerebral oedema that, in the surgeon's opinion, poses unacceptable risk
of post-operative oedema. This decision may be at time of surgery.

15. Presence of concurrent malignancy, except for adequately controlled limited basal
cell carcinoma of the skin or carcinoma in situ of the cervix
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