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A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma

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Trial Information

A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma


PRIMARY OBJECTIVES:

I. Determine the response rate in patients with relapsed or refractory, diffuse or
mediastinal, large B-cell lymphoma treated with sunitinib malate.

II. Determine the toxicity of this drug in these patients. III. Determine the effects of
this drug on peripheral blood biomarkers, circulating endothelial cells, and their
precursors in these patients.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4
weeks for a maximum of 12 courses in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3
months thereafter.

Inclusion Criteria


Criteria:

- Histologically confirmed diffuse or mediastinal large B-cell lymphoma*, meeting the
following criteria: Advanced or metastatic disease, Incurable by standard therapies,
Relapsed or refractory disease [Note: *Patients with diffuse large B-cell lymphoma
whose disease has transformed from an earlier diagnosis of low grade lymphoma (i.e.,
an indolent histology) are eligible]

- Bidimensionally measurable disease** by CT scan, MRI, or physical exam, with >= 1
disease site meeting 1 of the following criteria: Lymph nodes >= 1.5 cm x 1.5 cm by
spiral CT scan, Non-nodal regions >= 1 cm x 1 cm by MRI, CT scan, or physical exam
[Note: **Bone lesions are not considered bidimensionally measurable disease]

- Received 1-2 prior chemotherapy regimens that included doxorubicin hydrochloride;
Prior stem cell transplantation and high-dose chemotherapy is considered one regimen;
One prior non-chemotherapy regimen in the form of radiation allowed; Measurable
disease must be outside the previously irradiated area;

- No sole site of disease in a previously irradiated area unless progressive disease or
new lesions are documented; Low-dose palliative radiotherapy may be allowed

- No known brain metastases

- Life expectancy >= 12 weeks

- ECOG performance status 0-1

- Absolute granulocyte count >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- Bilirubin normal

- Calcium =< 3 mmol/L

- Creatinine =< 1.25 times ULN OR creatinine clearance >= 60 mL/min

- LVEF normal by MUGA

- None of the following in the past 12 months: cardiac arrhythmia, cerebrovascular
accident (CVA), coronary/peripheral artery bypass graft or stenting, myocardial
infarction, stable or unstable angina, symptomatic congestive heart failure,
transient ischemic attack, pulmonary embolism

- No uncontrolled hypertension (systolic blood pressure >= 140 mm Hg or diastolic blood
pressure >= 90 mm Hg)

- No New York Heart Association (NYHA) class III or IV heart disease

- No QTc prolongation (QTc interval >= 500 msec) or other significant ECG abnormalities

- No other prior malignancies except nonmelanoma skin cancer, in situ cervical cancer,
or other solid tumors curatively treated with no evidence of disease for >= 5 years

- No history of allergic reaction to compounds of similar chemical or biological
composition to sunitinib malate

- No other serious illness or medical condition that would preclude study
participation, including, but not limited to, the following:

active, uncontrolled infection, serious or nonhealing wound, ulcer, or bone fracture,
history of significant neurologic or psychiatric disorder that would impair the ability to
obtain consent or limit compliance

- Other medical condition that might be aggravated by treatment

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days

- No bowel obstruction

- No condition that would impair the ability to swallow and retain sunitinib malate
tablets, including any of the following:

Gastrointestinal tract disease resulting in inability to take oral medication or a
requirement for IV alimentation, Prior surgical procedures affecting absorption, Active
peptic ulcer disease

- No pre-existing hypothyroidism unless euthyroid on medication

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- At least 28 days since prior chemotherapy

- At least 28 days since prior radiotherapy and recovered; radiotherapy must have
involved < 30% of functioning bone marrow

- At least 28 days since prior major surgery and recovered

- At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the
following: rifampin, phenytoin, rifabutin, hypericum perforatum (St. John's wort),
carbamazepine, efavirenz, phenobarbital, tipranavir,

- At least 7 days since prior and concurrent CYP3A4 inhibitors, including any of the
following: azole antifungals (e.g., ketoconazole, itraconazole), verapamil,
clarithromycin, HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir,
atazanavir, nelfinavir), erythromycin, delavirdine, diltiazem,

- No prior therapy with other antiangiogenic agents or multitargeted tyrosine kinase
inhibitors, including any of the following:

bevacizumab, sorafenib tosylate, pazopanib, thalidomide, AZD2171 vandetanib, AMG 706,
vatalanib, VEGF Trap

- No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g.,
warfarin); Concurrent dosing of =< 2 mg of warfarin daily for prophylaxis of
thrombosis is allowed; Concurrent low molecular weight heparin is allowed provided
INR is =< 1.5

- No other concurrent anticancer treatments, including investigational agents

- No concurrent agents with proarrhythmic potential, including any of the following:
terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil,
haloperidol, risperidone, indapamide, flecainide

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response, defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin's lymphoma

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Rena Buckstein

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCIC Clinical Trials Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00692

NCT ID:

NCT00392496

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Stage IV Adult Diffuse Large Cell Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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