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

This study is ongoing, but not recruiting participants.
Study NCT00031941.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
Official Title  A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory Metastatic Cancer
Brief Summary

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.

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 Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Intervention  Drug: lenalidomide
MEDLINE PMIDs 15522712
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  April 2002
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00031941
Organization ID CDR0000069241
Secondary IDs †† NCI-02-C-0083
Study Sponsor  NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     William Dahut, MD     NCI - Center for Cancer Research-Medical Oncology    
Information Provided By National Cancer Institute (NCI)
Verification Date December 2006
First Received Date  March 8, 2002
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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