Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Recurrent Mantle Cell Lymphoma

Recurrent Adult Diffuse Large Cell Lymphoma

Anaplastic Large Cell Lymphoma

Treatments

Other: laboratory biomarker analysis

Drug: sorafenib tosylate

Study type

Interventional

Funder types

NIH

Identifiers

NCT00278382

GCC0508

NCI-2012-02682

CDR0000456442 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

OUTLINE: This is an open-label study.

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

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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