|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00036894 |
Purpose
RATIONALE: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: lenalidomide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas |
| Study Start Date: | March 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (yes vs no).
Patients receive oral CC-5013 weekly for 3 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A maximum of 80 patients (40 per stratum) will be accrued for this study within 20 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following:
Histologically confirmed high-grade glioma
Progressive or recurrent disease as determined by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
More Information
| Study ID Numbers: | CDR0000069338, NCI-02-C-0145 |
| Study First Received: | May 13, 2002 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00036894 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma adult ependymoblastoma adult anaplastic ependymoma |
adult myxopapillary ependymoma adult meningioma adult meningeal hemangiopericytoma adult brain stem glioma adult grade III meningioma adult giant cell glioblastoma adult gliosarcoma |
|
Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Lenalidomide Central Nervous System Neoplasms Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |