NCT00278382

Brief Summary

Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's lymphoma

Trial Health

80
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

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, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

2.2 years

First QC Date

January 16, 2006

Last Update Submit

February 6, 2013

Conditions

Anaplastic Large Cell LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (complete and partial response)

    Will be calculated as the percent of evaluable patients whose best response is a CR or PR. The exact binomial method will be used to determine the confidence interval of response rate.

    Up to 2 years

Secondary Outcomes (2)

  • Overall survival

    Up to 2 years

  • Time to disease progression

    Up to 2 years

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity.

Drug: sorafenib tosylateOther: laboratory biomarker analysis

Interventions

sorafenib tosylateDRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Treatment (sorafenib tosylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (sorafenib tosylate)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed aggressive\* non-Hodgkin's lymphoma by excisional-node biopsy or core needle biopsy and bone marrow biopsy, including 1 of the following types:
  • Mantle cell lymphoma
  • Primary mediastinal large B-cell lymphoma
  • Diffuse large B-cell lymphoma
  • Anaplastic large cell lymphoma (T-cell or null-cell type)
  • Recurrent disease
  • Patients must have received ≥ 1 induction regimen containing anthracyclines (e.g., CHOP \[with or without rituximab\] or R-EPOCH)
  • Chemosensitive disease at the time of relapse
  • Patients who responded with a complete or partial remission that lasted at least 8 weeks after their last chemotherapy regimen are considered chemosensitive
  • Measurable disease, defined as a lymph node or a nodal mass of \> 1 cm in its longest transverse diameter on CT scan
  • Ineligible for, refused, or relapsed after stem cell transplant (for patients with non-mantle cell lymphoma)
  • No known brain metastases, including meningeal involvement
  • ECOG performance status (PS) 0-2
  • Karnofsky PS 60-100%
  • Life expectancy \> 3 months
  • +35 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201-1595, United States

Location

MeSH Terms

Conditions

Lymphoma, Large-Cell, AnaplasticLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Meyer Heyman

    University of Maryland Greenebaum Cancer Center

    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

January 16, 2006

First Posted

January 18, 2006

Study Start

October 1, 2005

Primary Completion

December 1, 2007

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

US(1)