CC-5013 in Treating Patients With Recurrent Glioma

NCT ID: NCT00036894

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

lenalidomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Howard A. Fine, MD

Role: STUDY_CHAIR

NCI - Neuro-Oncology Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18056189 (View on PubMed)

Other Identifiers

NCI-02-C-0145

Identifier Type: -

Identifier Source: secondary_id

CDR0000069338

Identifier Type: -

Identifier Source: org_study_id

NCT00032214

Identifier Type: -

Identifier Source: nct_alias