Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

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

Secondary

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³ (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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Howard Fine, MD, Principal investigator		Ph: 301-402-6298

Related Information

Featured trial article

Registry Information
Official Title		A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas
Trial Start Date		2003-12-07
Registered in ClinicalTrials.gov		NCT00074243
Date Submitted to PDQ		2003-10-29
Information Last Verified		2006-11-20

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