PXD101 and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of PXD101 and bortezomib in treating patients with advanced solid tumors or lymphomas. PXD101 and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PXD101 may also cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving PXD101 together with bortezomib may kill more cancer cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Belinostat; Bortezomib

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