Status:
COMPLETED
Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Glioblastoma
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Study Objectives: Primary Objective: To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-...
Detailed Description
Study Objectives: Primary Objective: To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients will be included in the study if they meet all of the following criteria:
- Male or female at least 18 years of age.
- Histological results confirming GBM are available.
- Progressive GBM (greater than or equal to 25 percent 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.
- 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.
- Patient is not considered a candidate for resection.
- 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 TransMID (Trademark)). Male patients must be willing to use a barrier method of contraception for up to 2 months after the last treatment with TransMID (Trademark)
- Able and willing to follow instructions and comply with the protocol.
- Provide written informed consent prior to participation in the study.
- Karnofsky Performance Scale Score 70-100.
- Tumor characteristics:
- i) must be unifocal; and
- ii) must be unilateral and supratentorial; and
- iii) lesion must have a diameter (on contrast-enhanced MRI) greater than or equal to 1.0 cm and less than or equal to 4.0 cm.
- EXCLUSION CRITERIA:
- Patients will be excluded from the study if they meet any of the following criteria:
- Anticipated life expectancy of less than 3 months.
- Infratentorial or intraventricular tumors.
- Presence of satellite tumors.
- Chemotherapy within 30 days prior to study entry or nitrosureas or Mitomycin-C containing therapy within 42 days prior to study entry.
- Radiotherapy or stereotactic (gamma knife) radiosurgery within 90 days prior to study entry.
- Tumor surgery, tumor debulking or other neurosurgery within 30 days prior to study entry.
- Previous administration of TransMID (Trademark)
- Previous enrollment in this study.
- 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.
- Significant liver function impairment-(total bilirubin greater than 2.0 mg/dl or 34.2 mircomol/L; AST or ALT greater than 3 times the upper limit of normal).
- Significant renal impairment (serum creatinine greater than 1.7 mg/dL or 150 micromol/L).
- Coagulopathy (prothrombin time \[PT\] or activated partial thromboplastin time \[APTT\] greater than 1.5 times control).
- Thrombocytopenia (platelet count less than 100 x 10(3)/micro-L or 100 x 10(9)/L).
- Granulocytopenia (absolute neutrophil count (ANC), less than 1 x 10(3)/micro-L or 1.0 x 10(9)/L).
- Severe acute infection.
- Medical condition that is considered an unacceptable anesthetic risk.
- 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.
- Nursing or pregnant females. A pregnancy test will be performed on all females who are of child-bearing potential.
- Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry.
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00088400
Start Date
July 1 2004
End Date
November 1 2005
Last Update
September 22 2016
Active Locations (1)
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1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892