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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031941
• Other study ID #: 020083
• Secondary ID: 02-C-0083CDR0000
• Status: Completed
• Phase: Phase 1
• First received: March 8, 2002
• Last updated: March 14, 2012
• Start date: April 2002
• Est. completion date: April 2009

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00029081

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Small Intestine Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• lenalidomide

Locations

Country	Name	City	State
United States	NCI - Center for Cancer Research	Bethesda	Maryland
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Dahut WL, Aragon-Ching JB, Woo S, Tohnya TM, Gulley JL, Arlen PM, Wright JJ, Ventiz J, Figg WD. Phase I study of oral lenalidomide in patients with refractory metastatic cancer. J Clin Pharmacol. 2009 Jun;49(6):650-60. doi: 10.1177/0091270009335001. — View Citation

Tohnya TM, Hwang K, Lepper ER, Fine HA, Dahut WL, Venitz J, Sparreboom A, Figg WD. Determination of CC-5013, an analogue of thalidomide, in human plasma by liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Nov 25;811(2):135-41. — View Citation