Status:
COMPLETED
Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00392496
Start Date
February 1 2007
End Date
January 1 2012
Last Update
May 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Institute of Canada Clinical Trials Group
Kingston, Ontario, Canada, K7L 3N6