Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors

NCT00088400 | Completed Phase 3

• 2 other identifiers: 04024404-N-0244
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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-resectable glioblastoma multiforme. Secondary Objectives: To assess the safety of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme. To evaluate possible differences in efficacy and/or safety with TransMID associated with differing degrees of transferrin receptor expression in tumor tissue and serum anti-diphtheria toxin antibody titer levels. Study Design: Multicenter, open label, randomized study comparing TransMID with a chemotherapeutic regimen considered to be best standard of care and consisting of either nitrosureas, platinum compounds, temozolomide, procarbazine or PCV (procarbazine, lomustine (CCNU) \& vincristine). A planned interim analysis of the primary efficacy endpoint will be conducted after approximately 50 percent of the required events have been observed.

Conditions

Glioblastoma

Keywords

Transferrin; Brain Tumor; Convection; Immunotherapy; Targeted Protein Toxin; Glioblastoma Multiforme; GBM

Interventions

TransMID DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ameri A, Poisson M, Chen QM, Delattre JY. Treatment of recurrent malignant supratentorial gliomas with the association of procarbazine, thiotepa and vincristine: a phase II study. J Neurooncol. 1993 Jul;17(1):43-6. doi: 10.1007/BF01054273.

  PMID: 8120571 BACKGROUND

• Angelova-Gateva P. Iron transferrin receptors in rat and human cerebrum. Agressologie. 1980;21(1):27-30. No abstract available.

  PMID: 6263123 BACKGROUND

• Bobo RH, Laske DW, Akbasak A, Morrison PF, Dedrick RL, Oldfield EH. Convection-enhanced delivery of macromolecules in the brain. Proc Natl Acad Sci U S A. 1994 Mar 15;91(6):2076-80. doi: 10.1073/pnas.91.6.2076.

  PMID: 8134351 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Tf-CRM107

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 23, 2004
• First Posted: July 26, 2004
• Study Start: July 1, 2004
• Study Completion: November 1, 2005
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

US (1)