Study of Therapy With TransMID™ Compared to Best Standard of Care in Patients With Glioblastoma Multiforme

NCT ID: NCT00083447

Last Updated: 2009-01-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-06-30

Brief Summary

TransMID treatment or best standard of care for patients with advanced glioblastoma multiforme

Glioblastoma multiforme (GBM) is a type of brain tumour. GBM tumours are usually treated with surgery and radiotherapy. Unfortunately, this type of brain tumour may continue to grow or come back (recur) despite treatment.

This trial will compare a new drug called TransMID with the best standard treatment that is currently available. TransMID is a drug that is a combination of a protein called transferrin and a poison called diphtheria toxin.

Cancer cells need iron in order to continue to grow. They need more iron than normal cells. Transferrin helps cells to take up available iron. So the cancer cells are attached to the transferrin in TransMID, and the diphtheria poison kills them. The aim of this treatment is to kill the cancer cells while not affecting the normal brain cells. This treatment for brain tumours may have fewer side effects than other treatments because it targets cancer cells.

The best standard treatment will involve giving chemotherapy. You may have chemotherapy as part of the treatment when you are diagnosed. Or it may be kept in reserve to treat your brain tumour if it comes back or continues to grow. Your cancer specialist (consultant) will decide which chemotherapy drugs you should have.

Detailed Description

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

TransMID™

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xenova Biomedix

INDUSTRY

Sponsor Role: lead

Locations

University of California-San Diego

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

Yale University

New Haven, Connecticut, United States

Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

University of Chicago

Chicago, Illinois, United States

University of Iowa Hospitals in Clinics

Cedar Rapids, Iowa, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Johns Hopkins Medical Center

Baltimore, Maryland, United States

NINDS National Institutes of Health

Bethesda, Maryland, United States

Fairview University Medical Center

Minneapolis, Minnesota, United States

Saint Louis University Hospital

St Louis, Missouri, United States

Cooper University Hospital

Camden, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Columbia University Medical Center

New York, New York, United States

SUNY Upstate Medical University at Syracuse

Syracuse, New York, United States

New York Medical College

Valhalla, New York, United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Legacy Emanuel Hospital and Technology Center

Portland, Oregon, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Semmes-Murphey Neurologic Institute

Memphis, Tennessee, United States

University of Utah

Salt Lake City, Utah, United States

Medical College of Virginia

Richmond, Virginia, United States

Neville Knuckey, MD

Nedlands, Western Australia, Australia

Countries

United States; Australia

Other Identifiers

KSB311R/CIII/001

Identifier Type: -

Identifier Source: org_study_id

NCT00087230

Identifier Type: -

Identifier Source: nct_alias