Recurrent Glioblastoma Multiforme Clinical Trial
Official title:
Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme
RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine
131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor
cells and deliver radiation directly to the center of the tumor mass while minimizing
effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out."
This may be an effective treatment for glioblastoma multiforme, a malignant type of brain
cancer.
PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients
with recurrent glioblastoma multiforme.
OBJECTIVES:
Primary
- To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of
131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in
patients with recurrent GBM
- To characterize the biodistribution and radiation dosimetry of Cotara®
OUTLINE:
This is an open-label, dose escalation study of Cotara®.
All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry
purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara®
for confirmation of the maximum tolerated dose (MTD). After completion of study treatment,
patients are followed for a minimum of 12 weeks and until disease progression.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00597493 -
Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM
|
Phase 2 | |
| Completed |
NCT00379470 -
Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)
|
Phase 3 | |
| Recruiting |
NCT01737346 -
Procarbazine and Lomustine in Recurrent Glioblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT01464177 -
Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
|
Phase 2 | |
| Active, not recruiting |
NCT00562419 -
CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan
|
Phase 2 | |
| Completed |
NCT00071539 -
Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT02062827 -
Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma
|
Phase 1 | |
| Recruiting |
NCT05868083 -
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma
|
Phase 1 | |
| Completed |
NCT01576666 -
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01738646 -
Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients
|
Phase 2 | |
| Completed |
NCT00306618 -
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
|
Phase 2 | |
| Completed |
NCT01934361 -
Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme
|
Phase 1 | |
| Recruiting |
NCT04915404 -
Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV)
|
Phase 1/Phase 2 | |
| Terminated |
NCT01756729 -
Post-approval Study of NovoTTF-100A in Recurrent GBM Patients
|
Phase 4 | |
| Completed |
NCT00747253 -
Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
|
Phase 1 | |
| Completed |
NCT00883298 -
Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
|
Phase 2 | |
| Completed |
NCT00481455 -
Phase 2 Study of Panzem Nanocrystal Colloidal Dispersion (NCD) in Combination With Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme (GBM)
|
Phase 2 | |
| Recruiting |
NCT03423628 -
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
|
Phase 1 | |
| Recruiting |
NCT04689087 -
A Prospective, Open-label, Single-arm Clinical Study
|
N/A |