PXD101 and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas
Adult Grade III Lymphomatoid Granulomatosis, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
About this trial
This is an interventional treatment trial for Adult Grade III Lymphomatoid Granulomatosis
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed solid tumor or lymphoma that is refractory to standard therapy or for which no standard therapy exists No active, untreated, or symptomatic brain metastases Patients with treated brain metastases are eligible provided metastasis are stable and the patient is off all steroids and anticonvulsants ECOG performance status 0-2 Life expectancy ≥ 12 weeks WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 mg/dL AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases) Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101, bortezomib, boron, or mannitol No peripheral neuropathy > grade 1 No uncontrolled intercurrent illness, including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Psychiatric illness or social situation that would preclude study requirements No significant cardiovascular disease, including any of the following: Myocardial infarction within the past 6 months New York Heart Association class III-IV heart failure Unstable angina pectoris Uncontrolled hypertension Condition requiring antiarrhythmic therapy Ischemic or severe valvular heart disease Acute ischemia or active conduction system abnormalities by ECG No marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval > 500 msec), long QT syndrome, or required use of concurrent medication during PXD101 administration that may cause torsade de pointes No severe medical or psychiatric problems of that would preclude study compliance At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin C) At least 4 weeks since prior radiotherapy and recovered At least 2 weeks since prior palliative radiotherapy to sites involving < 35% of bone marrow reserve At least 4 weeks since prior investigational agents At least 2 weeks since prior valproic acid or any other histone deacetylase inhibitor No prior stem cell or bone marrow transplantation No concurrent radiotherapy or immunotherapy No concurrent hormonal therapy Luteinizing hormone-releasing hormone agonists, selective estrogen receptor modulators, or aromatase inhibitors as chronic maintenance therapy allowed No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer agents or therapies
Sites / Locations
- University of Colorado
Arms of the Study
Arm 1
Experimental
PXD101 in Combination with Bortezomib (PS-341)
Patients receive PXD101 IV over 30 minutes on days 1-5 and bortezomib IV on days 1, 4, 8, and 11 (2, 5, 8, and 11 during course 1).