Glioblastoma Multiforme Clinical Trial
Official title:
Phase II Trial for Patients With Glioblastoma Multiforme (GBM) Treated With Gliadel Followed by Avastin Plus Irinotecan
The primary objective of the study is to use 24 week survival to assess the efficacy of the combination of Gliadel followed by Avastin and irinotecan in the treatment of grade IV malignant glioma patients following surgical resection. The secondary objectives are to determine the progression-free survival following the combination of Gliadel followed by Avastin and irinotecan and to describe the toxicity of Gliadel followed by Avastin and irinotecan.
This is a phase II study of the combination of Gliadel followed by Avastin and irinotecan in
grade IV malignant glioma patients. The study will have survival and toxicity endpoints.
Subjects will be identified by the investigator as those patients who have histologically
documented grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with recurrent
or progressive disease who are able to undergo a gross total resection (GTR).
Part I: Gliadel wafer- 1-8 wafers inserted at time of gross total resection. Treatment cycle
is 42 days in length. For patients with ≥ Grade 1 toxicity will allow 84 days prior to
beginning therapy with Avastin and Irinotecan (CPT-11).
Part II: Avastin Plus Irinotecan (Cycles 1-12) consists of the following (cycle length is 6
weeks):
- Irinotecan 125 mg/m2 (not taking enzyme-inducing anti-epileptic drugs (EIAEDs)) or 340
mg/m2 (taking EIAEDs) given every two weeks on days 1, 15, 29, etc.;
- If the patient has the uridine diphosphate (UDP) glucuronosyltransferase 1 family,
polypeptide A1 (UGT1A1) polymorphism (7/7), they do not metabolize the irinotecan
normally, so these patients will start out at a two dose level reduction; For patients
on an EIAED, the starting dose will be 275 mg/M2, and for patients not on an EIAED, the
starting dose will be 75 mg/M2;
- Avastin 10 mg/kg immediately after the irinotecan given every 2 weeks on days 1, 15,
29, etc.
The primary objective of this phase II study is to determine whether the administration of
Gliadel wafers followed by Avastin and irinotecan to patients with recurrent GBM is a
treatment regimen worthy of further investigation in a randomized clinical trial. The basis
for making this decision will be the proportion of patients who survive at least 24 weeks
after initiation of protocol treatment.
In the initial Phase I and II clinical trials, four potential Avastin-associated safety
signals were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage.
The two major toxicities associated with irinotecan are myelosuppression and diarrhea. Side
effects associated with Gliadel are seizures, brain edema (swelling), healing abnormalities,
wound infection and body pain.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05023551 -
Study of DSP-0390 in Patients With Recurrent High-Grade Glioma
|
Early Phase 1 | |
Recruiting |
NCT06059690 -
Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells
|
Phase 1/Phase 2 | |
Recruiting |
NCT04116411 -
A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
|
Phase 2 | |
Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
Completed |
NCT00038493 -
Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
|
Phase 2 | |
Withdrawn |
NCT03980249 -
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|
Early Phase 1 | |
Recruiting |
NCT01923922 -
CT Perfusion in the Prognostication of Cerebral High Grade Glioma
|
N/A | |
Completed |
NCT01956734 -
Virus DNX2401 and Temozolomide in Recurrent Glioblastoma
|
Phase 1 | |
Completed |
NCT01301430 -
Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
|
Phase 1/Phase 2 | |
Suspended |
NCT01386710 -
Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma
|
Phase 1/Phase 2 | |
Completed |
NCT01402063 -
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
|
Phase 2 | |
Active, not recruiting |
NCT00995007 -
A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas
|
Phase 2 | |
Terminated |
NCT01044966 -
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Terminated |
NCT00990496 -
A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
|
Phase 1 | |
Completed |
NCT00402116 -
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
|
Phase 1/Phase 2 | |
Completed |
NCT00112502 -
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
|
Phase 2 | |
Completed |
NCT00504660 -
6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
|
Phase 2 | |
Recruiting |
NCT05366179 -
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
|
Phase 1 |