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

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT00031941

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific	Drug: lenalidomide	Phase 1

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Apr 1, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182
2	NCI - Center for Cancer Research	Bethesda	Maryland	United States	20892