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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074243
• Other study ID #: CDR0000343702
• Secondary ID: NCI-04-C-0035
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2003
• Last updated: April 29, 2015
• Start date: December 2003

Study information

• Verified date: November 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00071864

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• CC-8490

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,