CC-5013 in Treating Patients With Recurrent Glioma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Lenalidomide

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