Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell Lymphoma
Adult Diffuse Large Cell Lymphoma · Recurrent Adult Diffuse Large Cell Lymphoma · Stage IV Adult Diffuse Large Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00392496 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sunitinib malate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Tumor Response |
— | — |
Summary
Eligibility 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 = = 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, delav
Data sourced from ClinicalTrials.gov (NCT00392496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.