Glioblastoma Clinical Trial
Official title:
A Phase I Trial of the Addition of the Farnesyl Transferase Inhibitor, SCH 66336, to Temodar for Patients With Grade 3 and 4 Malignant Gliomas
Objectives:
To determine maximum tolerated dose of farnesyl transferase inhibitor, SCH 66336, when
administered w TEMODAR®.
To characterize any toxicity associated w combo of farnesyl transferase inhibitor, SCH
66336, & TEMODAR®.
To observe patients for clinical antitumor response when treated with combination of
farnesyl transferase inhibitor, SCH 66336, & TEMODAR®.
To assess pharmacokinetics of SCH 66336 for patients on & not on enzyme inducing
antiepileptic drugs.
2 separate strata accrued independently of each other: Stratum1-Patients receiving Dilantin,
Tegretol / phenobarbital. Stratum2-Patients on anti-convulsants other than Dilantin,
Tegretol / phenobarbital / Patients not on any anti-convulsants. Each stratum treated &
escalated independent of each other. Temozolomide administered orally at dose of 150mg/m2
daily for 5 days, at bedtime, for 1st cycle & escalated to 200mg/m2 daily for 5 days, at
bedtime during subsequent cycles if tolerated. Treatment cycles may be repeated every 4
weeks following doses of Temozolomide from previous cycle. SCH 66336 administered orally
twice day, approximately every 12hrs. Initial doses will be 125mg BID for stratum 1 & 75mg
for stratum 2. Treatment cycles may be repeated every 4 weeks following dose of Temozolomide
from previous cycle.
Subjects are patients with malignant glioma histologically confirmed at diagnosis, who were
treated previously with conventional external beam radiation (XRT) & with or without chemo,
& have stable disease, recurrence/relapse at time of enrollment. Approximately 48 subjects
will be enrolled.
Temozolomide has been well tolerated by both adults & children with most common toxicity
being mild myelosuppression. Other, less likely, potential toxicities include nausea &
vomiting, constipation, headache, alopecia, rash, burning sensation of skin, esophagitis,
pain, diarrhea, lethargy, & hepatotoxicity. Hypersensitivity reactions have not yet been
noted with Temozolomide. As is case with many anti-cancer drugs, Temozolomide may be
carcinogenic. Rats given Temozolomide have developed breast cancer. Significance of this
finding for humans is not presently known.
Significant adverse events observed for SCH66336 have included vomiting, diarrhea, anorexia,
headaches, reversible renal toxicities, & hematological toxicities. SCH 66336, although not
genotoxic, inhibits rapidly proliferating cells & at high doses inhibits spermatogenesis in
male rats. It is not clear that inhibition of spermatogenesis is reversible,& patients
should be advised of possibility of irreversible sterility.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05664243 -
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02768389 -
Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
|
Early Phase 1 | |
| Recruiting |
NCT05635734 -
Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
| Completed |
NCT03679754 -
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
|
Phase 1 | |
| Completed |
NCT01250470 -
Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
|
Phase 1 | |
| Terminated |
NCT03927222 -
Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
|
Phase 2 | |
| Recruiting |
NCT03897491 -
PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT03587038 -
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
|
Phase 1 | |
| Completed |
NCT01922076 -
Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
|
Phase 1 | |
| Recruiting |
NCT04391062 -
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT03661723 -
Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT02655601 -
Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
|
Phase 2 | |
| Completed |
NCT02206230 -
Trial of Hypofractionated Radiation Therapy for Glioblastoma
|
Phase 2 | |
| Completed |
NCT03493932 -
Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
|
Phase 1 | |
| Terminated |
NCT02709889 -
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
| Completed |
NCT03018288 -
Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
|
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 | |
| Not yet recruiting |
NCT04552977 -
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma
|
Phase 2 | |
| Withdrawn |
NCT02876003 -
Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma
|
Phase 2 |