Lymphoma Clinical Trial
Official title:
Phase I Study of Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Indolent B-Cell Lymphoma, Peripheral T-Cell Lymphoma or Cutaneous T-Cell Lymphoma
Verified date | April 2018 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I trial studies the side effects and best dose of giving bortezomib and romidepsin together in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), indolent B-cell lymphoma, peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). Bortezomib and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Status | Completed |
Enrollment | 18 |
Est. completion date | April 13, 2018 |
Est. primary completion date | July 17, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: - CLL or SLL, relapsed or refractory - Indolent B-cell lymphoma, relapsed or refractory: - Follicle center lymphoma, follicular or diffuse - Marginal zone B-cell lymphoma (splenic, nodal, extranodal [this includes mucosa associated lymphoid tissue (MALT)]) - Lymphoplasmacytic lymphoma - PTCL, relapsed or refractory: - Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK)-positive - Anaplastic large cell lymphoma, ALK-negative - Angioimmunoblastic T-cell lymphoma - Enteropathy-associated T-cell lymphoma - Extranodal natural killer (NK)/T-cell lymphoma, nasal type - Hepatosplenic T-cell lymphoma - PTCL, not otherwise specified (NOS) - Subcutaneous panniculitis-like T-cell lymphoma - CTCL: * CTCL with subtypes of mycosis fungoides Stage IB or higher, Sézary syndrome, or primary cutaneous anaplastic large cell lymphoma who have failed a previous systemic treatment, as per the following: - Stage IA plaque, IB, or IIA: At least 4 prior conventional and/or experimental regimens (topical or systemic, including psoralen-ultraviolet light [PUVA] and systemic corticosteroids) - Stage IIB, III, or IV: At least 1 prior systemic regimen (systemic corticosteroids alone or PUVA alone do not count as systemic regimens for this purpose) NOTE: Repeated use of the same regimen is considered 1 regimen - Prior allogeneic stem cell transplant is allowed provided that all of the following conditions are met: - >= 6 months have elapsed since allogeneic transplant - No Graft vs. Host Disease (GVHD) is present - Not currently on immunosuppressive therapy - No prior or concurrent CNS malignancy PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - ANC > 1,500/mm^3 - Platelet count > 75,000/mm^3 - Hemoglobin > 7.5 g/dL (transfusion allowed) - Serum creatinine = 1.2 mg/dL or actual or calculated creatinine clearance > 60 mL/min - AST and ALT = 2.5 times upper limit of normal (ULN) - Bilirubin = ULN - Serum potassium = 3.5 mEq/L (supplementation allowed) - Serum magnesium = 1.7 mEq/L (supplementation allowed) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective non-hormonal contraception - Willing and able to comply with protocol requirements - No prior severe allergic reactions to bortezomib, boron, mannitol, or romidepsin - No progressing toxicity secondary to bortezomib - No grade 1 peripheral neuropathy with pain or = grade 2 peripheral neuropathy by NCI-CTCAE criteria (v4.0) within the past 14 days - No condition related to ischemic heart disease, heart failure, or the risk of torsades de pointes or sudden cardiac death, including any of the following: - History of sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, or resuscitated cardiac arrest unless currently addressed with an implantable cardiac defibrillator - Baseline heart rate > 140 beats per minute - Known congenital long QT syndrome - QTc interval > 480 milliseconds - Type II second-degree atrio-ventricular (AV) block, third-degree AV block, or ventricular rate < 50 beats per minute - Myocardial infarction within the past 6 months - Patients who have had a myocardial infarction 6-12 months ago are eligible provided they are asymptomatic and have a negative cardiac risk assessment (i.e., treadmill stress test, nuclear medicine stress test, or stress echocardiogram) - Angina upon ordinary physical activity - Angina only with strenuous, rapid, or prolonged exertion allowed - ECG with evidence of cardiac ischemia, as defined by the following: - ST depression of = 2 mm, measured from isoelectric line to ST segment - T-wave inversion = 4 mm, measured from isoelectric line to peak of T-wave - NYHA class II-IV congestive heart failure - Known left ventricular ejection fraction < 40% by MUGA scan or < 50% by echocardiogram or MRI - Known hypertrophic cardiomegaly or restrictive cardiomyopathy - No uncontrolled hypertension, defined as persistent blood pressure = 160/95 mm Hg despite medical management - No clinically significant active infection, including known HIV infection or hepatitis B or C - No other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy, or curatively treated low-risk prostate cancer - No concurrent medical condition that, in the investigator's opinion, would compromise study treatment or assessment of toxicity PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 3 weeks since prior chemotherapy, radiation therapy or investigational agents. If steroids for cancer control have been used, patients must be off theses agents for at least 1 week before starting treatment. (Maintenance therapy for non-malignant disease with prednisone or steroid equivalent dose less than 10 mg/day is permitted) - Prior allogeneic stem cell transplantation allowed provided all of the following conditions are met: - Greater than or equal to 6 months have elapsed since allogeneic transplant - No Graft vs. Host Disease (GVHD) is present - More than 4 weeks since prior bortezomib - No concurrent oral hormonal contraceptives - No concurrent potent or moderate CYP3A4 inhibitors - No concurrent anti-arrhythmic agents - No concurrent treatment with any drugs that are generally accepted to having a risk of causing torsades de pointes (class 1 drugs) - Class 2 or 3 drugs allowed at the discretion of the investigator - No other concurrent systemic therapy for the malignancy - Concurrent warfarin (coumadin) allowed |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Greenebaum Cancer Center | Baltimore | Maryland |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois |
United States | Vanderbilt-Ingram Cancer Center, Vanderbilt University | Nashville | Tennessee |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | National Cancer Institute (NCI) |
United States,
Holkova B, Yazbeck V, Kmieciak M, Bose P, Ma S, Kimball A, Tombes MB, Shrader E, Wan W, Weir-Wiggins C, Singh A, Hogan KT, Conine S, Sankala H, Roberts JD, Shea TC, Grant S. A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose | Dose at which no more than 1 dose-limiting toxicity is observed in as many as 6 patients | 2 years | |
Secondary | Pharmacodynamic responses | To explore candidate pharmacodynamic markers for use in subsequent phase II trials. | 2 years |
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