Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving enzastaurin together with temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of enzastaurin when given together with temozolomide in treating patients with primary gliomas.


Clinical Trial Description

OBJECTIVES:

- To assess if full doses of enzastaurin hydrochloride and temozolomide can be used in combination for the treatment of patients with primary gliomas.

- To determine the recommended phase II dose.

OUTLINE: This is a multicenter study.

Patients receive oral enzastaurin hydrochloride once or twice daily on days 1-28* and oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *During the first course only, patients also receive enzastaurin hydrochloride on day -1.

Patients undergo blood sample collection on day 22 of course 1 and on day 5 of course 2 for pharmacokinetic studies of enzastaurin hydrochloride.

After completion of study treatment, patients are followed within 30 days and then every 3 months thereafter. ;


Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00516607
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Active, not recruiting
Phase Phase 1
Start date July 2007

See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT00006080 - Fenretinide in Treating Patients With Recurrent Malignant Glioma Phase 2
Recruiting NCT00887146 - Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma Phase 3
Suspended NCT00935090 - 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer N/A
Completed NCT00621686 - Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme 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
Terminated NCT00227032 - Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme Phase 1
Terminated NCT00243022 - Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme Phase 2
Active, not recruiting NCT00087815 - Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain N/A
Active, not recruiting NCT00278278 - Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas Phase 3
Completed NCT00416819 - Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma N/A
Completed NCT00052286 - Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer N/A
Completed NCT00006093 - EMD 121974 in Treating Patients With Progressive or Recurrent Glioma Phase 1/Phase 2
Recruiting NCT00004129 - Phosphorus 32 in Treating Patients With Glioblastoma Multiforme Phase 1
Completed NCT00004212 - DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00003417 - Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme Phase 1/Phase 2
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Completed NCT00003484 - Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors Phase 1
Completed NCT00008008 - Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma Phase 2
Completed NCT00003020 - LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases Phase 1