CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy

March 14, 2012 updated by: National Institutes of Health Clinical Center (CC)

A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory Metastatic Cancer

RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors and/or lymphoma that did not respond to previous therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of CC-5013 in patients with refractory solid tumors and/or lymphoma.
  • Characterize the pharmacokinetic profile of this drug in these patients.
  • Determine whether any correlations can be made between plasma concentrations of this drug and toxicity or clinical activity or biological activity in these patients.
  • Characterize the side effect profile of this drug in these patients.
  • Determine the dose-limiting toxicity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral CC-5013 on day 1. Within 4-10 days, patients begin second course and receive oral CC-5013 once daily on days 1-21. Subsequent courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 3-51 patients will be accrued for this study.

Study Type

Interventional

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, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
      • Bethesda, Maryland, United States, 20892
        • NCI - Center for Cancer Research

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed refractory solid tumor and/or lymphoma
  • No brain metastases or primary CNS malignancies

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • ALT and AST less than 2.5 times normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No unstable or newly diagnosed angina pectoris
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class II, III, or IV congestive heart failure

Pulmonary:

  • No chronic obstructive lung disease requiring oxygen therapy

Other:

  • No uncontrolled seizures
  • No concurrent acute critical illness
  • No serious untreated infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or carboplatin)
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy
  • Concurrent luteinizing hormone-releasing hormone agonist required in patients with prostate cancer unless prior orchiectomy has been performed

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • See Endocrine therapy
  • Prior surgery allowed

Other:

  • Recovered from prior therapy
  • No concurrent anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine)
  • No concurrent rifampin
  • No concurrent grapefruit juice

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

Collaborators and Investigators

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

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: William Dahut, MD, NCI - Medical Oncology Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2002

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

March 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

March 15, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020083
  • 02-C-0083
  • CDR0000069241

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.

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