NCT00036894

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 30, 2015

Status Verified

November 1, 2003

First QC Date

May 13, 2002

Last Update Submit

April 29, 2015

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult mixed gliomaadult ependymoblastomaadult anaplastic ependymomaadult myxopapillary ependymomaadult meningiomaadult meningeal hemangiopericytomaadult brain stem gliomaadult grade III meningiomaadult giant cell glioblastomaadult gliosarcoma

Interventions

lenalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • 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.

    PMID: 18056189RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaOligodendrogliomaGliomaNeuroectodermal Tumors, PrimitiveEpendymomaMeningiomaGliosarcoma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Vascular TissueMeningeal Neoplasms

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Howard A. Fine, MD

    NCI - Neuro-Oncology Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

May 13, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Last Updated

April 30, 2015

Record last verified: 2003-11

Locations

US(1)