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

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.

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.

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