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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme

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Trial Information

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


This is a Multicenter, open label, randomized study comparing TransMID™ with a
chemotherapeutic regimen considered to be best standard of care and consisting of either
nitrosoureas, platinum compounds, temozolomide, procarbazine, PCV, (procarbazine, lomustine
(CCNU) & vincristine), CPT-11, or Etoposide. A planned interim analysis of the primary
efficacy endpoint will be conducted after approximately 50% of the required events have been
observed.

In order for a patient to be eligible for enrollment into this trial, he/she must be
diagnosed with glioblastoma multiforme which has been confirmed histologically and have
undergone conventional treatment, including surgery (biopsy or debulking) and/or radiation
therapy and/or chemotherapy, have a recurrent and/or progressive tumor ≥1.0 cm and ≤4.0 cm
in diameter.


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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival time i.e. to to death

Authority:

United States: Food and Drug Administration

Study ID:

KSB311R/CIII/001

NCT ID:

NCT00083447

Start Date:

May 2004

Completion Date:

June 2007

Related Keywords:

  • Glioblastoma Multiforme
  • brain tumor
  • GBM
  • glioblastoma
  • glioblastoma multiforme
  • brain cancer
  • treatment
  • Glioblastoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Medical University of South CarolinaCharleston, South Carolina  29425-0721
New York Medical CollegeValhalla, New York  10595
Cooper University HospitalCamden, New Jersey  08103
Fairview University Medical CenterMinneapolis, Minnesota  55455
Temple University HospitalPhiladelphia, Pennsylvania  19140
University of UtahSalt Lake City, Utah  
Medical College of VirginiaRichmond, Virginia  23298-0341
University of Colorado Health Sciences CenterDenver, Colorado  80262
Saint Louis University HospitalSt. Louis, Missouri  63110-0250
Yale UniversityNew Haven, Connecticut  06520
University of ChicagoChicago, Illinois  60637
University of Kentucky Medical CenterLexington, Kentucky  40536-0093
Johns Hopkins Medical CenterBaltimore, Maryland  
University of Southern CaliforniaLos Angeles, California  90033
Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Columbia University Medical CenterNew York, New York  10032
University of California-San DiegoLa Jolla, California  92037-0698
University of Iowa Hospitals in ClinicsCedar Rapids, Iowa  52242
NINDS National Institutes of HealthBethesda, Maryland  
SUNY Upstate Medical University at SyracuseSyracuse, New York  13210
University of North Carolina - Chapel HillChapel Hill, North Carolina  27599
Legacy Emanuel Hospital and Technology CenterPortland, Oregon  97227
Semmes-Murphey Neurologic InstituteMemphis, Tennessee  38104