NCT00278382CompletedPhase 2

A Phase 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas

National Cancer Institute (NCI)1 site in 1 country33 target enrollmentStarted: October 2005Last updated: February 7, 2013

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: National Cancer Institute (NCI)
Enrollment: 33
Locations: 1
Primary Endpoint: Objective response rate (complete and partial response)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the overall response rate, including complete and partial responses, in patients with chemosensitive, relapsed, aggressive, non-Hodgkin's lymphoma treated with sorafenib.

SECONDARY OBJECTIVES:

I. Determine progression-free and overall survival of patients treated with this drug.

II. Determine response duration in patients treated with this drug.

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•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
•WBC ≥ 3,000/mm^3
•Absolute neutrophil count ≥ 1,500/mm^3
•Platelet count ≥ 100,000/mm^3
•Bilirubin normal
•AST and ALT ≤ 2.5 times upper limit of normal
•Creatinine normal OR creatinine clearance ≥ 60 mL/min
•Fertile patients must use effective contraception
•Not pregnant or nursing
•Negative pregnancy test
•No uncontrolled illness
•No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
•No known positive HIV serology
•No inflammatory bowel disease
•No swallowing dysfunction that would prevent ingestion of pills
•No hemorrhagic diathesis
•No ongoing or active infection
•No symptomatic congestive heart failure
•No unstable angina pectoris
•No cardiac arrhythmia
•No uncontrolled hypertension
•No psychiatric or social situation that would limit compliance with study requirements
•No poorly controlled medical condition that would seriously complicate compliance with this study
•Patients with inflammatory or exfoliative skin disease are excluded (regardless of the extent of the involvement) unless the skin condition is lymphoma related
•See Disease Characteristics
•Previous treatment-related toxic effects should be resolved to grade 1 or better
•No chemotherapy or radiation therapy within the past 4 weeks
•6 weeks for nitrosoureas or mitomycin C
•No prior antibody therapy for at least 3 months
•Prior radiation for localized disease or total body irradiation as part of a conditioning regimen prior to stem cell transplant allowed
•Prior radio-immunotherapy allowed
•No concurrent therapeutic anticoagulation
•Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices are acceptable provided that the requirements for PT, INR, and PTT are met
•No concurrent use of another investigational agent
•No concurrent use of the following drugs: phenytoin, carbamazepine, phenobarbital, rifampin, or Hypericum perforatum (St. John's wort)
•No other concurrent anticancer therapy

Exclusion Criteria

Not provided

Arms & Interventions

Treatment (sorafenib tosylate)

Experimental

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

Intervention: sorafenib tosylate (Drug)

Treatment (sorafenib tosylate)

Experimental

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

Intervention: laboratory biomarker analysis (Other)

Outcomes

Primary Outcomes

Objective response rate (complete and partial response)

Time Frame: Up to 2 years

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.

Secondary Outcomes

Overall survival(Up to 2 years)
Time to disease progression(Up to 2 years)

Investigators

Sponsor

National Cancer Institute (NCI)

Sponsor Class

Nih

Responsible Party

Sponsor

Study Sites (1)

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