NCT00052416

Brief Summary

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_1 leukemia

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

Study Start

First participant enrolled

October 1, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

June 26, 2013

Status Verified

April 1, 2003

First QC Date

January 24, 2003

Last Update Submit

June 25, 2013

Conditions

LeukemiaLymphoma

Keywords

B-cell chronic lymphocytic leukemiastage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiastage I grade 1 follicular lymphomastage III grade 1 follicular lymphomastage IV grade 1 follicular lymphomacontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomastage I grade 2 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 2 follicular lymphomaWaldenström macroglobulinemiacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone 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

thalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed indolent lymphoma or leukemia of one of the following subtypes: * Chronic lymphocytic leukemia * Follicular center lymphoma (grade I or II) * Lymphoplasmacytic lymphoma * Marginal zone lymphoma (nodal, extranodal, or splenic) * Small lymphocytic lymphoma * Waldenstrom's macroglobulinemia * Any stage of disease allowed * No hairy cell leukemia * No T-cell lymphomas * No prior treatment for lymphoma/leukemia * Considered appropriate for expectant management * Must not require cytotoxic therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Hemoglobin greater than 10.0 g/dL * Platelet count greater than 75,000/mm\^3 Hepatic * Bilirubin no greater than 2 times normal * AST and ALT no greater than 2 times normal Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No uncontrolled congestive heart failure * No New York Heart Association class III or IV heart disease * No unstable coronary artery disease * No myocardial infarction in the past 6 months * No serious or uncontrolled arrhythmias * No history of thromboembolic disease Pulmonary * No asthma or chronic obstructive pulmonary disease requiring the use of home oxygen or frequent oral steroids (prednisone greater than 20 mg per day for 5 days within the past 3 months) Other * HIV negative * Not pregnant or nursing * Negative pregnancy test * Not planning to become pregnant in the next 2 years * Fertile female patients must use 1 highly effective method and 1 additional effective method of contraception for 1 month prior to, during, and for 1 month after study participation * Male patients must use effective barrier contraception during and for 1 month after study participation * Willing and able to participate in the S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety) program * No contraindications to meeting the requirements of the S.T.E.P.S. program * No other prior malignancy except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix * No peripheral neuropathy * No poorly controlled diabetes defined by either of the following: * Glycosylated hemoglobin greater than 8.0 g/dL * Known end organ disease (i.e., nephropathy, retinopathy, or neuropathy) * No other concurrent illness that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularWaldenstrom MacroglobulinemiaLymphoma, B-Cell, Marginal Zone

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Robin Joyce, MD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

October 1, 2002

Study Completion

January 1, 2003

Last Updated

June 26, 2013

Record last verified: 2003-04

Locations

US(2)