Phase I Trial of CC-8490 for the Treatment of Subjects With Recurrent/Refractory High-Grade Gliomas

January 2, 2007 updated by: Celgene Corporation
Phase I trial of CC-8490 for the treatment of subjects with recurrent/refractory high-grade gliomas

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-8200
        • Neuro Oncology BranchNational Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with glioblastoma multiforme (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), malignant glioma/astrocytoma NOS (not otherwise specified). Also included will be radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy. Other CNS tumor histologies will not be eligible for this trial.
  • Patients must have shown either evidence for tumor recurrence or progression by CT or (preferably) MRI scan performed within 21 days prior to registration or had biopsy proven recurrent glioma within the last 12 weeks prior to enrollment (in order to allow the enrollment of patients with recurrent gliomas who have undergone a complete radiographic resection and now have no radiographic evaluable disease)
  • Patients having undergone recent resection of a recurrent or progressive tumor will be eligible two weeks after surgery.
  • Patient must have failed prior radiation therapy and must have an interval of greater than or equal to 2 weeks from the completion of radiation therapy to study entry.
  • All patients must sign an informed consent, or if cognitively impaired, their assigned DPA, indicating that they are aware of the investigational nature of this study.
  • Patients must be > 18 years old, and must have a life expectancy > 8 weeks.
  • Patients must have a Karnofsky performance status of > 60.
  • Additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide or carboplatin, 3 weeks from procarbazine, and 2 weeks from last vincristine administration. Patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon, tamoxifen).
  • Patients must have adequate bone marrow function (granulocyte count >= 1500/mm3, platelet count of > 100,000/mm3, and hemoglobin > 8 gm%), adequate liver function (total bilirubin <= 1.5 mg/dL, AST/ALT <= 2 x ULN), and adequate renal function (creatinine <= 1.5 mg/dL or creatinine clearance > 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion. Eligibility level for platelets may not be reached by transfusion.
  • Patients must either not be receiving steroids, or be on a stable dose of steroids for at least five days prior to registration.
  • Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) are ineligible, unless they are in complete remission and off all therapy for that disease for a minimum of 3 years.
  • Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control during and for 2 months after treatment with CC-8490. Women of childbearing potential (WCBP) who are sexually active must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
  • Patients must be able to swallow capsules whole.

Exclusion Criteria:

  • Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases that would significantly increase the risk of using CC-8490 are ineligible.
  • Concurrent use of other standard chemotherapeutics or investigative agents.
  • Pregnant or lactating females.
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, obscures the evaluation of toxicity or alters drug metabolism.
  • Use of other experimental study drug within 28 days of registration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

December 17, 2003

First Submitted That Met QC Criteria

December 18, 2003

First Posted (Estimate)

December 19, 2003

Study Record Updates

Last Update Posted (Estimate)

January 4, 2007

Last Update Submitted That Met QC Criteria

January 2, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-8490-GLIO-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma

Clinical Trials on CC-8490

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe