Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory diffuse or mediastinal large B-cell lymphoma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Sunitinib

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