Clinical trial NCT00036894: CC-5013 in Treating Patients With Recurrent Glioma
Official title: A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult ependymoblastoma
adult anaplastic ependymoma
adult myxopapillary ependymoma
adult meningioma
adult meningeal hemangiopericytoma
adult brain stem glioma
adult grade III meningioma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
Study officials:
affiliation: NCI - Neuro-Oncology Branch
name: Howard A. Fine, MD
role: STUDY_CHAIR
References:
citation: 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.