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CC-5013 in Treating Patients With Recurrent Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 13, 2002
Last Updated
April 29, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00036894
Brief Title
CC-5013 in Treating Patients With Recurrent Glioma
Official Title
A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
November 2003
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lenalidomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard A. Fine, MD
Organizational Affiliation
NCI - Neuro-Oncology Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18056189
Citation
Fine HA, Kim L, Albert PS, Duic JP, Ma H, Zhang W, Tohnya T, Figg WD, Royce C. A phase I trial of lenalidomide in patients with recurrent primary central nervous system tumors. Clin Cancer Res. 2007 Dec 1;13(23):7101-6. doi: 10.1158/1078-0432.CCR-07-1546.
Results Reference
result

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CC-5013 in Treating Patients With Recurrent Glioma

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