Kia[a]
A Phase III Multicenter Study of Intratumoral/Interstitial Therapy with TransMIDTM Compared to Best Standard of Care in Patients with Progressive and/or Recurrent, Non-Resectable Glioblastoma Multiforme
Age Group: Adults Only
Min Karnofsky Score: 70:
Cares for self, unable to perform normal activity or to do active work
Conditions:
Prior Surgery is Allowed
Prior Radiation is Allowed
Prior Chemotherapy is Allowed
Patients diagnosed with glioblastoma multiforme which has been confirmed histologically and who have undergone conventional treatment, including surgery (biopsy or debulking) and/or radiation therapy and/or chemotherapy, who have a recurrent and/or progressive tumor ≥1.0 cm and ≤4.0 cm in diameter
Comments:
Inclusion criteria Patients will be included in the study if they meet all of the following criteria: [1] Male or female at least 18 years of age [2] Histological results confirming GBM are available [3] Progressive GBM (≥ 25% increase in contrast enhanced tumor CSA compared to the nadir or smallest previous measured CSA) and/or recurrent GBM after conventional treatment, including surgery (biopsy or debulking surgery) and/or radiation therapy and/or chemotherapy [4] Pre-study MRIs used to determine current progression and/or recurrence of GBM are available to the Investigator and for independent confirmation of progression and/or recurrence [5] Patient is not considered a candidate for resection [6] If female of child-bearing potential, a reliable method of contraception must be combined with a negative pregnancy test before entering the study (female patients must be willing to use contraception for 2 months after the last treatment with TransMIDTM). Male patients must be willing to use a barrier method of contraception for up to 2 months after the last treatment with TransMIDT [7] Able and willing to follow instructions and comply with the protocol [8] Provide written informed consent prior to participation in the study [9] Karnofsky Performance Scale Score 70-100 [10] Tumor characteristics: i) must be unifocal; and ii) must be unilateral and supratentorial; and iii) lesion must have a diameter (on contrast-enhanced MRI) ≥1.0 cm and ≤4.0 cm Exclusion criteria Patients will be excluded from the study if they meet any of the following criteria: [1] Anticipated life expectancy of less than 3 months [2] Infratentorial or intraventricular tumors [3] Presence of satellite tumors [4] Chemotherapy within 30 days prior to study entry or nitrosoureas or Mitomycin-C containing therapy within 42 days prior to study entry [5] Radiotherapy or stereotactic (gamma knife) radiosurgery within 90 days prior to study entry [6] Tumor surgery, tumor debulking or other neurosurgery within 30 days prior to study entry [7] Previous administration of TransMIDTM [8] Previous enrolment in this study [9] Regional therapy including administration of biodegradable polymer wafers containing carmustine within 90 days prior to study entry or brachytherapy within 12 calendar months prior to study entry [10] Significant liver function impairment (total bilirubin > 2.0 mg/dL or 34.2 μmol/L; AST or ALT > 3 times the upper limit of normal) [11] Significant renal impairment (serum creatinine > 1.7 mg/dL or 150 µmol/L) [12] Coagulopathy (prothrombin time [PT] or activated partial thromboplastin time [APTT] >1.5 times control) [13] Thrombocytopenia (platelet count < 100 x 103/μL or 100 x 109/L) [14] Granulocytopenia (absolute neutrophil count (ANC), < 1 x 103/μL or 1.0 x 109/L) [15] Severe acute infection [16] Medical condition that is considered an unacceptable anesthetic risk [17] Evidence of a mass effect on CT or MRI with more than a 5 mm midline shift and/or nausea, vomiting, reduced level of consciousness or clinically significant papilledema [18] Nursing or pregnant females. A pregnancy test will be performed on all females who are of child-bearing potential [19] Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry
Contact:
Ronald Monroe, MD MD
Director of Clinical Programs
Xenova Biomedix
3000 Atrium Way
Suite 201
Mt Laurel , NJ 08054 USA
Phone: 856-273-6057
Fax: 856-273-6053