Study of Carfilzomib and Vorinostat for Relapsed or Refractory Lymphoma

Completed · Phase 1

Conditions studied: Lymphoma

In brief

This will be a phase I study of carfilzomib in combination with vorinostat in patients with relapsed/refractory B-cell lymphomas. Combination therapy with proteosome inhibitor PR-171 and HDAC inhibitors is highly synergistic in primary DLBCL cells, and both classes of drugs can also synergize powerfully to induce cell death in bortezomib-resistant cells. The purpose of this study is to see if vorinostat can combine with carfilzomib and to safely find the recommended phase II dose.

Key facts

Study ID

NCT01276717

Run by

University of Rochester

People needed

20

Starts

2011-01-01

Expected to finish

2015-01-01

Last updated by the study team

2015-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed B-cell lymphomas, excluding CLL (Chronic Lymphocytic Leukemia), that is recurrent or refractory after at least one prior therapy and for which no other potentially curative therapy is available.
• Age ≥ 18 years
• ECOG Performance Status (PS) ≤ 2
• Laboratory parameters
• if SLL, lymphocyte count < 5,000/µL
• Absolute neutrophil count ≥ 1000/µL
• Platelets ≥ 75,000/µL
• Creatinine ≤ 1.5x upper limit of normal or calculated creatinine clearance > 40mL/min
• AST, ALT ≤ 2.5 x upper limit of normal (ULN)
• Bilirubin ≤ 2.0 mg/mL
• Serum potassium ≥ 3.5 mEq/L and serum magnesium ≥ 1.7 mEq/dL (electrolytes may be corrected with supplementation).
• PT < 1.5 x ULN and PTT < 1.2 x ULN (unless receiving therapeutic anticoagulation).
• Patient is, in investigator's opinion, willing and able to comply with the protocol requirements and offers written informed consent.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control ( i.e., oral injectable hormonal methods; barrier methods such as intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence)for the duration of the study.
• Male subject agrees to use an acceptable method for contraception for the duration of study.

You may not qualify if…

• History of brain metastasis including leptomeningeal metastasis.
• Chemotherapy of radiotherapy within 3 weeks prior to entering the study.
• Prior histone deacetylase inhibitor as cancer treatment.
• Concurrent treatment with other investigational agents or cancer treatment.
• Unable to take oral medications.
• Active ischemic heart disease or congestive heart failure. If there is suspicion of cardiac disease, left ventricular ejection fraction (LVEF) must be ≥ 45%, otherwise study to evaluate EF is not required.
• Persistent blood pressure (BP) of ≥ 160/95 (three separate readings on different days).
• History of allergic reactions attributed to compounds of similar chemical or biological composition to carfilzomib and vorinostat.
• Known clinical significant infection including infection with human immunodeficiency virus (HIV), or active hepatitis B or C, requiring treatment.
• Serious medical or psychiatric illness likely to interfere with patient participation.
• Pregnant or nursing. Confirmation that a woman is not pregnant must be established by a negative serum pregnancy test result obtained at screening.
• Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• No prior allogeneic stem cell transplant.
• Patients scheduled for any type of stem cell transplant within 4 weeks of treatment.
• Patients who have valproic acid for epilepsy can enroll, provided that they stopped drug at least 30 days prior to enrollment and they will be on a stable, effective dose of an alternative anti-seizure medication.

Where it is running

• University of Rochester — Rochester, New York, United States
• Virginia Commonwealth University Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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