CC-5013 in Treating Patients With Recurrent Glioma

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Brain and Central Nervous System Tumors

Treatments: Drug: lenalidomide

Study type: Interventional

Funder types: NIH

Identifiers

NCT00036894

CDR0000069338

NCI-02-C-0145

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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