Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000343702


NCT ID:

NCT00074243


Secondary ID:

NCI-04-C-0035


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Howard A. Fine, MD
Principal Investigator
NCI - Neuro-Oncology Branch

Study Dates

Start Date:December 2003
Verification Date:November 2006
Last Changed Date:April 29, 2015
First Received Date:December 10, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:CC-8490

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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