CC-5013 in Treating Patients With Recurrent Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036894
• Other study ID #: CDR0000069338
• Secondary ID: NCI-02-C-0145
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2002
• Last updated: April 29, 2015
• Start date: March 2002

Study information

• Verified date: November 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00032214

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• lenalidomide

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation