Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI NCI-02-C-0083 NCT00031941

Objectives

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

Entry Criteria

Disease Characteristics:

• Histologically confirmed refractory solid tumor and/or lymphoma



• No brain metastases or primary CNS malignancies

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Tohnya TM, Hwang K, Lepper ER, et al.: Determination of CC-5013, an analogue of thalidomide, in human plasma by liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 811 (2): 135-41, 2004.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

William Dahut, MD, Protocol chair		Ph: 301-435-8183 Email: dahutw@mail.nih.gov

Registry Information
Official Title		A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients with Refractory Metastatic Cancer
Trial Start Date		2002-04-01
Registered in ClinicalTrials.gov		NCT00031941
Date Submitted to PDQ		2002-01-16
Information Last Verified		2006-12-29

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