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CompletedNCT00031941Updated Mar 15, 2012

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

A Phase 1 interventional study of lenalidomide in Lymphoma, Small Intestine Cancer and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by National Institutes of Health Clinical Center (CC). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-15.

Sponsored by National Institutes of Health Clinical Center (CC) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • unspecified adult solid tumor, protocol specific
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • small intestine lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

Browse Lymphoma studies →

Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment

Interventions

  • Druglenalidomide
06

Study locations

2 sites
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    Bethesda, Maryland 20892-1182, United States
  • NCI - Center for Cancer Research
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • 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. doi: 10.1016/j.jchromb.2004.08.022. PubMed 15522712 ↗
  • 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. PubMed 19451403 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00031941
Lead sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Apr 2002
Primary completion
Sep 2007
Completion
Apr 2009
Last update
Mar 15, 2012

Study contacts

William Dahut, MD
study chair · NCI - Medical Oncology Branch
View the source record on ClinicalTrials.gov ↗

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