Adult Glioblastoma Clinical Trial
Official title:
A Phase I Single Arm Open Label Study of Erlotinib and 13-cis-Retinoic Acid (CRA) in Patients With Recurrent Malignant Gliomas
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given with isotretinoin in treating patients with recurrent malignant glioma. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may help cells that are involved in the body's immune response to work better. Giving erlotinib hydrochloride together with isotretinoin may kill more tumor cells
PRIMARY OBJECTIVES:
I. To determine the recommended phase II doses of erlotinib (erlotinib hydrochloride) and
13-cis-retinoic acid (CRA) when administered to adults with recurrent malignant glioma who
are not receiving cytochrome P450 enzyme-inducing antiepileptic drugs (EIAEDs).
SECONDARY OBJECTIVES:
I. To assess dose-related toxicities. II. To measure 6 month progression-free survival and
overall survival. III. To estimate response rates in those patients with measurable disease.
IV. To evaluate for epidermal growth factor receptor (EGFR)vIII, phosphatase and tensin
homolog (PTEN), cyclin D1, cyclin E, and RARbeta1 expression in tumor samples from enrolled
patients as predictors of clinical benefit from this combination.
OUTLINE: This is a dose-escalation study.
Patients receive isotretinoin orally (PO) once daily (QD) on days 1-21 and erlotinib
hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 2 years.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02530502 -
Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma
|
Phase 1 | |
Withdrawn |
NCT02194452 -
Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
|
N/A | |
Completed |
NCT00238303 -
Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
|
Phase 2 | |
Completed |
NCT00049387 -
Tipifarnib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
|
Phase 1 | |
Completed |
NCT02227901 -
Tipifarnib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
|
Phase 1 | |
Completed |
NCT02015819 -
Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas
|
Phase 1 | |
Active, not recruiting |
NCT02179086 -
Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
|
Phase 2 | |
Recruiting |
NCT04573140 -
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
|
Phase 1 | |
Active, not recruiting |
NCT00823797 -
Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma
|
Phase 2 | |
Completed |
NCT00045565 -
Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
|
Phase 1 | |
Completed |
NCT01977677 -
Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma
|
Phase 1/Phase 2 | |
Completed |
NCT01648348 -
Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme
|
Phase 1/Phase 2 | |
Completed |
NCT00004262 -
Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
|
Phase 1 | |
Terminated |
NCT01996527 -
3T MRI Biomarkers of Glioma Treatment Response
|
Early Phase 1 | |
Terminated |
NCT01575275 -
Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme
|
Phase 2 | |
Completed |
NCT01131234 -
Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01119599 -
RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
|
Phase 1 | |
Completed |
NCT00459381 -
Pazopanib in Treating Patients With Recurrent Glioblastoma
|
Phase 2 | |
Completed |
NCT00316849 -
Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
|
Phase 1 | |
Terminated |
NCT00006773 -
Bortezomib in Treating Patients With Recurrent Glioma
|
Phase 1 |