CC-5013 in Treating Patients With Recurrent Glioma
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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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antiangiogenic activity of this drug in these patients.
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
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant glioma/astrocytoma, not otherwise specified
- Meningioma
- Hemangioblastoma
- Ependymoma
- Primitive neuroectodermal tumors
- Hemangiopericytoma
- Progressive glioma
- Clinically and radiographically diagnosed brain stem glioma
Progressive or recurrent disease as determined by CT scan or MRI
- Biopsy allowed for prior recent (i.e., within the past 12 weeks) resection of recurrent or progressive tumor
- Must have failed prior radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 8 weeks
Hematopoietic:
- WBC at least 2,300/mm^3
- Platelet count at least 90,000/mm^3
- Hemoglobin at least 8 g/dL (transfusions allowed)
Hepatic:
- Bilirubin less than 3 times upper limit of normal (ULN)
- SGOT less than 3 times ULN
- No significant active hepatic disease
Renal:
- Creatinine less than 2.0 mg/dL OR
- Creatinine clearance at least 60 mL/min
- No significant active renal disease
Cardiovascular:
- No significant active cardiac disease
Other:
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No significant active psychiatric disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 2 weeks since prior interferon
- No concurrent immunotherapy
Chemotherapy:
- At least 6 weeks since prior nitrosoureas
- At least 4 weeks since prior temozolomide or carboplatin
- At least 3 weeks since prior procarbazine
- At least 2 weeks since prior vincristine
- At least 4 weeks since other prior cytotoxic chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- At least 2 weeks since prior tamoxifen
- Concurrent steroids allowed for control of the signs and symptoms of increased intracranial pressure if on a stable dose for at least the past 5 days
Radiotherapy:
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 2 weeks since prior tumor resection
Other:
- At least 2 weeks since other prior noncytotoxic agents
- Concurrent enzyme-inducing antiepileptic drugs allowed
- No concurrent rifampin
- No concurrent grapefruit juice
- No other concurrent investigational agents
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
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00036894 History of Changes |
| Obsolete Identifiers: | NCT00032214 |
| Other Study ID Numbers: | CDR0000069338, NCI-02-C-0145 |
| Study First Received: | May 13, 2002 |
| Last Updated: | December 13, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Lenalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013