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Phase 2 N=19 Treatment

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

Enrolled (actual)
19
Serious AEs
76.5%
Results posted
Dec 2013
Primary outcome: Primary: Objective Tumor Response — 0 participants

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

OutcomeResultp-value
PRIMARY
Objective Tumor Response

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.

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
View full record on ClinicalTrials.gov →

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.

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