CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas

NCT ID: NCT00074243

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas.

Detailed Description

OBJECTIVES:

Primary

• Determine the maximum tolerated dose of CC-8490 in patients with recurrent or refractory high-grade gliomas.
• Determine, preliminarily, the toxic effects of this drug in these patients.
• Determine the pharmacokinetics of this drug in these patients.

Secondary

• Determine, preliminarily, the potential anti-glioma activity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral CC-8490 once daily on days 1 and 3-28 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive oral CC-8490 once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CC-8490 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, a total of 10 patients are treated at that dose.

Patients are followed within 2 weeks.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

CC-8490

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed supratentorial malignant glioma, including any of the following:

• Glioblastoma multiforme
• Gliosarcoma
• Anaplastic astrocytoma
• Anaplastic oligodendroglioma
• Anaplastic mixed oligoastrocytoma
• Malignant glioma/astrocytoma not otherwise specified OR
• Clinical and radiographic diagnosis of progressive low-grade glioma
• Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy allowed
• Recurrent or progressive disease as determined by 1 of the following:

• CT scan or MRI within the past 21 days
• Biopsy within the past 12 weeks
• Failed prior radiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3 (transfusion independent)
• Hemoglobin at least 8 g/dL (transfusion allowed)

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 2 times upper limit of normal
• No significant active hepatic disease that would preclude study participation

Renal

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min
• No significant active renal disease that would preclude study participation

Cardiovascular

• No significant active cardiac disease that would preclude study participation

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study participation
• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No significant active psychiatric disease that would preclude study participation
• No other condition or laboratory abnormality that would preclude study participation
• Able to swallow capsules whole

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 2 weeks since prior interferon
• No concurrent immunotherapy

Chemotherapy

• At least 2 weeks since prior vincristine
• At least 3 weeks since prior procarbazine
• At least 4 weeks since prior temozolomide or carboplatin
• At least 6 weeks since prior nitrosoureas
• No other concurrent anticancer chemotherapy

Endocrine therapy

• At least 2 weeks since prior tamoxifen
• Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment

Radiotherapy

• See Disease Characteristics
• At least 2 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• At least 2 weeks since prior resection of a recurrent or progressive tumor

Other

• At least 2 weeks since other prior non-cytotoxic therapy
• At least 4 weeks since other prior cytotoxic therapies
• More than 28 days since prior experimental study drugs
• 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: PRINCIPAL_INVESTIGATOR

NCI - Neuro-Oncology Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-04-C-0035

Identifier Type: -

Identifier Source: secondary_id

CDR0000343702

Identifier Type: -

Identifier Source: org_study_id

NCT00071864

Identifier Type: -

Identifier Source: nct_alias