NCT00031941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_1 lymphoma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2002

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

5.4 years

First QC Date

March 8, 2002

Last Update Submit

March 14, 2012

Conditions

LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomaunspecified adult solid tumor, protocol specificstage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomarecurrent mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromesmall intestine lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

lenalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • 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.

    PMID: 15522712BACKGROUND

  • 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.

    PMID: 19451403RESULT

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphadenopathyLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • William Dahut, MD

    NCI - Medical Oncology Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Primary Completion

September 1, 2007

Study Completion

April 1, 2009

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(2)