NCT00015912

Brief Summary

Phase II trial to study the effectiveness of combining thalidomide with interferon alfa in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of cancer cells. Combining thalidomide with interferon alfa may kill more tumor cells

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2001

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 15, 2003

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

May 6, 2001

Last Update Submit

January 24, 2013

Conditions

Recurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Response rate (complete and partial)

    Up to 2 years

Secondary Outcomes (2)

  • Time to progression

    Up to 2 years

  • Overall survival

    Up to 2 years

Study Arms (1)

Treatment (interferon-alpha, thalidomide)

EXPERIMENTAL

Patients receive interferon alfa subcutaneously every 12 hours and oral thalidomide daily in the absence of disease progression or unacceptable toxicity.

Biological: recombinant interferon alfaDrug: thalidomideOther: laboratory biomarker analysis

Interventions

recombinant interferon alfaBIOLOGICAL

Given IV

Also known as: Alferon N, alpha interferon, IFN-A, Intron A, Roferon-A
Treatment (interferon-alpha, thalidomide)
thalidomideDRUG

Given orally

Also known as: Kevadon, Synovir, THAL, Thalomid
Treatment (interferon-alpha, thalidomide)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (interferon-alpha, thalidomide)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed relapsed or refractory low-grade follicular non-Hodgkin's lymphoma (NHL)
  • WHO grade 1 or 2
  • Failure to achieve a complete or partial remission after prior treatment regimen
  • Relapse or disease progression within 30 days after prior treatment regimen
  • No histologic transformation to aggressive NHL or areas of diffuse NHL
  • At least 1 measurable lesion by CT scan, MRI, or chest x-ray
  • Tissue in the form of tissue blocks available
  • No brain metastasis or primary brain tumors
  • Performance status - ECOG 0-1
  • More than 3 months
  • Absolute neutrophil count greater than 1,500/mm\^3
  • Platelet count greater than 100,000/mm\^3
  • Hemoglobin greater than 8.5 g/dL
  • Bilirubin no greater than 1.5 mg/dL
  • SGOT/SGPT no greater than 2.5 times upper limit of normal
  • +39 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Denver, Colorado, 80217-3364, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Interferon-alphaInterferon Alfa-n3IntronsInterferon alpha-2Thalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenesPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • John Sweetenham

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2001

First Posted

October 15, 2003

Study Start

July 1, 2001

Primary Completion

September 1, 2003

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)