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Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors

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

NCT00088400•National Institute of Neurological Disorders and Stroke (NINDS)

View on ClinicalTrials.gov

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.

Detailed Description

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients will be included in the study if they meet all of the following criteria:
•1. Male or female at least 18 years of age.
•2. Histological results confirming GBM are available.
•3. 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.
•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 (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)
•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.
+4 more criteria

Exclusion Criteria

•Patients will be excluded from the study if they meet any of the following 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 nitrosureas or Mitomycin-C containing therapy within 42 days prior to study entry.
•5. Radiotherapy or stereotactic (gamma knife) radiosurgery within 90 days prior to study entry.
•6. Tumor surgery, tumor debulking or other neurosurgery within 30 days prior to study entry.
•7. Previous administration of TransMID (Trademark)
•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 more criteria

Locations (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, United States

Key Dates

Start Date

July 1, 2004

Completion Date

November 1, 2005

Last Updated

September 22, 2016

Enrollment

Estimated participants

Conditions

Glioblastoma

Interventions

TransMID

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITINGPHASE1

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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