search
Back to results

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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CC-8490
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult mixed glioma, adult brain stem glioma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 2003
Last Updated
April 29, 2015
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00074243
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult mixed glioma, adult brain stem glioma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CC-8490

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard A. Fine, MD
Organizational Affiliation
NCI - Neuro-Oncology Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs