Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00083447




Registration number
NCT00083447
Ethics application status
Date submitted
24/05/2004
Date registered
26/05/2004
Date last updated
7/01/2009

Titles & IDs
Public title
Study of Therapy With TransMID™ Compared to Best Standard of Care in Patients With Glioblastoma Multiforme
Scientific title
A Phase III Multicenter Study of Intratumoral/Interstitial Therapy With TransMID™ Compared to Best Standard of Care in Patients With Progressive and/or Recurrent, Non-Resectable Glioblastoma Multiforme
Secondary ID [1] 0 0
KSB311R/CIII/001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival time i.e. to to death
Timepoint [1] 0 0
Secondary outcome [1] 0 0
12 month survival rate
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Tumor Response
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Time to Progression
Timepoint [4] 0 0
Secondary outcome [5] 0 0
6 and 12 month progression rates
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Progression Free Survival
Timepoint [6] 0 0
Secondary outcome [7] 0 0
6 and 12 progression free survival rate
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Quality of Life
Timepoint [8] 0 0

Eligibility
Key inclusion 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 TransMID™). Male patients must be willing to use a barrier method of contraception for up to 2 months after the last treatment with TransMID™ 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion 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) External Beam irradiation within 60 days prior to study entry or stereotactic (gamma knife) radiosurgery within 90 days prior to study entry 6) Tumor surgery, tumor debulking or other neurosurgery within 5 days prior to study entry 7) Previous administration of TransMID™ 8) Previous enrollment 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 - AST or ALT > 2 times the upper limit of normal, total bilirubin > upper limit of normal 11) Hepatitis B surface antigen positive or positive Anti-Hepatitis C antibodies, or previous history of infectious Hepatitis (except previous Hepatitis A infection) 12) Significant renal impairment (serum creatinine > 1.7 mg/dL or 150 µmol/L) 13) Coagulopathy (prothrombin time [PT] or activated partial thromboplastin time [APTT] >1.5 times control) 14) Thrombocytopenia (platelet count < 100 x 103/µL or 100 x 109/L) 15) Granulocytopenia (absolute neutrophil count (ANC), < 1 x 103/µL or 1.0 x 109/L) 16) Severe acute infection 17) Medical condition that is considered an unacceptable anesthetic risk 18) 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 19) Nursing or pregnant females. A pregnancy test will be performed on all females who are of child-bearing potential 20) Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2007
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Neville Knuckey, MD - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Xenova Biomedix
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00083447