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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lenalidomide

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