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Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01638533
First received: July 9, 2012
Last updated: November 25, 2014
Last verified: August 2014
  Purpose

This phase I trial studies the side effects and best dose of romidepsin in treating patients with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction. Romidepsin may stop the growth of cancer cells by entering the cancer cells and by blocking the activity of proteins that are important for the cancer's growth and survival.


Condition Intervention Phase
Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Brain Stem Glioma
Adult Ependymoblastoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Mixed Glioma
Adult Nasal Type Extranodal NK/T-Cell Lymphoma
Adult Pineal Gland Astrocytoma
Adult Solid Neoplasm
AIDS Related Immunoblastic Lymphoma
AIDS-Related Burkitt Lymphoma
AIDS-Related Diffuse Large Cell Lymphoma
AIDS-Related Diffuse Mixed Cell Lymphoma
AIDS-Related Diffuse Small Cleaved Cell Lymphoma
AIDS-Related Hodgkin Lymphoma
AIDS-Related Lymphoblastic Lymphoma
AIDS-Related Lymphoma
AIDS-Related Primary Central Nervous System Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-Cell Lymphoma
Cutaneous B-Cell Non-Hodgkin Lymphoma
Extensive Stage Small Cell Lung Carcinoma
Extra-Adrenal Paraganglioma
Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Gastrin-Producing Neuroendocrine Tumor
Hepatic Complication
Hepatosplenic T-Cell Lymphoma
Intraocular Lymphoma
Lung Carcinoid Tumor
Lymphomatous Involvement of Non-Cutaneous Extranodal Site
Male Breast Carcinoma
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Metastatic Adrenal Gland Pheochromocytoma
Metastatic Gastrointestinal Neuroendocrine Tumor G1
Nasal Cavity Inverted Papilloma
Nodal Marginal Zone Lymphoma
Olfactory Neuroblastoma
Pancreatic Glucagonoma
Pancreatic Insulinoma
Pancreatic Polypeptide Tumor
Poorly Differentiated Thyroid Gland Carcinoma
Recurrent Adrenal Gland Pheochromocytoma
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Brain Neoplasm
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Adult T-Cell Leukemia/Lymphoma
Recurrent Bladder Carcinoma
Recurrent Breast Carcinoma
Recurrent Colon Carcinoma
Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma
Recurrent Gastrointestinal Neuroendocrine Tumor G1
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Inverted Schneiderian Papilloma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Laryngeal Verrucous Carcinoma
Recurrent Lip and Oral Cavity Squamous Cell Carcinoma
Recurrent Lip Basal Cell Carcinoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Melanoma
Recurrent Merkel Cell Carcinoma
Recurrent Metastatic Squamous Cell Carcinoma to the Neck With Occult Primary
Recurrent Mycosis Fungoides and Sezary Syndrome
Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Recurrent Nasal Type NK/T-Cell Lymphoma
Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Recurrent Nasopharyngeal Undifferentiated Carcinoma
Recurrent Non-Small Cell Lung Carcinoma
Recurrent Olfactory Neuroblastoma
Recurrent Oral Cavity Adenoid Cystic Carcinoma
Recurrent Oral Cavity Mucoepidermoid Carcinoma
Recurrent Oral Cavity Verrucous Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Oropharyngeal Undifferentiated Carcinoma
Recurrent Pancreatic Carcinoma
Recurrent Pancreatic Neuroendocrine Carcinoma
Recurrent Prostate Carcinoma
Recurrent Rectal Carcinoma
Recurrent Renal Cell Carcinoma
Recurrent Salivary Gland Carcinoma
Recurrent Small Cell Lung Carcinoma
Recurrent Small Lymphocytic Lymphoma
Recurrent Thyroid Gland Carcinoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Regional Adrenal Gland Pheochromocytoma
Regional Gastrointestinal Neuroendocrine Tumor G1
Small Intestinal Lymphoma
Somatostatin-Producing Neuroendocrine Tumor
Splenic Marginal Zone Lymphoma
Squamous Cell Carcinoma Metastatic to the Neck With Occult Primary
Stage III Adult Soft Tissue Sarcoma
Stage III Bladder Cancer
Stage III Hypopharyngeal Squamous Cell Carcinoma
Stage III Laryngeal Squamous Cell Carcinoma
Stage III Laryngeal Verrucous Carcinoma
Stage III Lip and Oral Cavity Squamous Cell Carcinoma
Stage III Lip Basal Cell Carcinoma
Stage III Major Salivary Gland Carcinoma
Stage III Merkel Cell Carcinoma
Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage III Nasal Type NK/T-Cell Lymphoma
Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Stage III Nasopharyngeal Undifferentiated Carcinoma
Stage III Oral Cavity Adenoid Cystic Carcinoma
Stage III Oral Cavity Mucoepidermoid Carcinoma
Stage III Oral Cavity Verrucous Carcinoma
Stage III Oropharyngeal Squamous Cell Carcinoma
Stage III Oropharyngeal Undifferentiated Carcinoma
Stage III Pancreatic Cancer
Stage III Prostate Cancer
Stage III Renal Cell Cancer
Stage III Thyroid Gland Follicular Carcinoma
Stage III Thyroid Gland Papillary Carcinoma
Stage IIIA Breast Cancer
Stage IIIA Colon Cancer
Stage IIIA Non-Small Cell Lung Cancer
Stage IIIA Rectal Cancer
Stage IIIA Skin Melanoma
Stage IIIB Breast Cancer
Stage IIIB Colon Cancer
Stage IIIB Non-Small Cell Lung Cancer
Stage IIIB Rectal Cancer
Stage IIIB Skin Melanoma
Stage IIIC Breast Cancer
Stage IIIC Colon Cancer
Stage IIIC Rectal Cancer
Stage IIIC Skin Melanoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Bladder Cancer
Stage IV Breast Cancer
Stage IV Hypopharyngeal Squamous Cell Carcinoma
Stage IV Merkel Cell Carcinoma
Stage IV Nasal Type NK/T-Cell Lymphoma
Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma
Stage IV Nasopharyngeal Undifferentiated Carcinoma
Stage IV Non-Small Cell Lung Cancer
Stage IV Pancreatic Cancer
Stage IV Prostate Cancer
Stage IV Renal Cell Cancer
Stage IV Skin Melanoma
Stage IVA Basal Cell Lip Carcinoma
Stage IVA Colon Cancer
Stage IVA Laryngeal Squamous Cell Carcinoma
Stage IVA Laryngeal Verrucous Carcinoma
Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVA Major Salivary Gland Carcinoma
Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVA Oral Cavity Adenoid Cystic Carcinoma
Stage IVA Oral Cavity Mucoepidermoid Carcinoma
Stage IVA Oral Cavity Verrucous Carcinoma
Stage IVA Oropharyngeal Squamous Cell Carcinoma
Stage IVA Oropharyngeal Undifferentiated Carcinoma
Stage IVA Rectal Cancer
Stage IVA Thyroid Gland Follicular Carcinoma
Stage IVA Thyroid Gland Papillary Carcinoma
Stage IVB Basal Cell Lip Carcinoma
Stage IVB Colon Cancer
Stage IVB Laryngeal Squamous Cell Carcinoma
Stage IVB Laryngeal Verrucous Carcinoma
Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVB Major Salivary Gland Carcinoma
Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVB Oral Cavity Adenoid Cystic Carcinoma
Stage IVB Oral Cavity Mucoepidermoid Carcinoma
Stage IVB Oral Cavity Verrucous Carcinoma
Stage IVB Oropharyngeal Squamous Cell Carcinoma
Stage IVB Oropharyngeal Undifferentiated Carcinoma
Stage IVB Rectal Cancer
Stage IVB Thyroid Gland Follicular Carcinoma
Stage IVB Thyroid Gland Papillary Carcinoma
Stage IVC Basal Cell Lip Carcinoma
Stage IVC Laryngeal Squamous Cell Carcinoma
Stage IVC Laryngeal Verrucous Carcinoma
Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma
Stage IVC Major Salivary Gland Carcinoma
Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Stage IVC Oral Cavity Adenoid Cystic Carcinoma
Stage IVC Oral Cavity Mucoepidermoid Carcinoma
Stage IVC Oral Cavity Verrucous Carcinoma
Stage IVC Oropharyngeal Squamous Cell Carcinoma
Stage IVC Oropharyngeal Undifferentiated Carcinoma
Stage IVC Thyroid Gland Follicular Carcinoma
Stage IVC Thyroid Gland Papillary Carcinoma
T-Cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Thyroid Gland Medullary Carcinoma
Thyroid Gland Undifferentiated (Anaplastic) Carcinoma
Tongue Carcinoma
Waldenstrom Macroglobulinemia
Drug: Romidepsin
Other: Pharmacological Study
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 and Pharmacokinetic Single Agent Study of Romidepsin in Patients With Lymphomas, Chronic Lymphocytic Leukemia and Select Solid Tumors and Varying Degrees of Liver Dysfunction

Resource links provided by NLM:

Drug Information available for: Romidepsin
Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Adenoid Cystic Carcinoma Anaplastic Astrocytoma Anaplastic Ependymoma Anaplastic Large Cell Lymphoma Anaplastic Oligodendroglioma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Angioimmunoblastic T-cell Lymphoma B-cell Lymphomas Brain Tumor, Adult Breast Cancer, Male Burkitt Lymphoma Carcinoid Syndrome Carcinoid Tumor Central Nervous System Lymphoma, Primary Chronic Lymphocytic Leukemia Cutaneous T-cell Lymphoma Embryonal Tumor With Multilayered Rosettes Ependymoma Esthesioneuroblastoma Follicular Lymphoma Glioblastoma Glioma Gliosarcoma Glucagonoma Glucagonoma Syndrome Hairy Cell Leukemia Hodgkin Lymphoma Insulinoma Kidney Cancer Large Granular Lymphocyte Leukemia Leukemia, B-cell, Chronic Leukemia, T-cell, Chronic Lymphoblastic Lymphoma Lymphoma AIDSrelated Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphomatoid Granulomatosis Lymphosarcoma Malignant Mesenchymal Tumor Mantle Cell Lymphoma Melanoma, Familial Merkel Cell Carcinoma Mucoepidermoid Carcinoma Mycosis Fungoides Neuroblastoma Neuroepithelioma Oligodendroglioma Oral Cancer Pancreatic Cancer Papillary Thyroid Carcinoma Paragangliomas 1 Pheochromocytoma Plasmablastic Lymphoma Primary Effusion Lymphoma Rectal Neoplasm Renal Cancer Sezary Syndrome Soft Tissue Sarcoma Somatostatinoma Thyroid Cancer, Follicular Thyroid Cancer, Medullary Tongue Cancer Waldenstrom Macroglobulinemia Zollinger-Ellison Syndrome
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • MTD of romidepsin in groups of patients with varying degree of hepatic dysfunction according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Analyses will be descriptive in nature. The observed toxicities will be characterized by dose level within each category of liver dysfunction (mild, moderate, severe, and liver transplant). These results will be summarized in relation to what is known about romidepsin in a population without liver dysfunction (as defined in this protocol).

  • Dose-limiting toxicity of romidepsin in groups of patients with varying degree of hepatic dysfunction according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    In order to define levels of hepatic impairment at which dose modifications of romidepsin are required, data will be combined across hepatic dysfunction groups to evaluate the association between toxicity, dose, and liver assay level(s). The outcome variable, drug tolerance and dose-limiting toxicities will be modeled as function of dose and liver assay using multivariate linear regression. Higher order terms of the predictor variables and interactions will be included if there is evidence of non-linear and/or non-additive associations.

  • PK profile of romidepsin in patients with varying degrees of hepatic dysfunction using liquid chromatography-electrospray ionization tandem mass spectrometric method [ Time Frame: 0, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 8, 10, 24, and 48 hours after initiation of the infusion on day 1 ] [ Designated as safety issue: No ]
    PK variables will be tabulated and descriptive statistics calculated for each function group. Geometric means and coefficients of variation will be presented for maximum concentration and area under the curve for each group.


Secondary Outcome Measures:
  • Child-Pugh classification of hepatic dysfunction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Correlations of the Child-Pugh classification of hepatic dysfunction with the observed toxicities and plasma PK of romidepsin administration will be explored.

  • Antitumor activity assessed using Response Evaluation Criteria in Solid Tumors and the International Workshop Lymphoma Response Criteria [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
    Association of antitumor activity and romidepsin treatment will be documented.


Estimated Enrollment: 132
Study Start Date: June 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (romidepsin)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Romidepsin
Given IV
Other: Pharmacological Study
Correlative studies
Other Name: pharmacological studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To establish the safety and tolerability of romidepsin given on days 1, 8, and 15 of a 28 day cycle to patients with varying degrees of liver dysfunction (mild, moderate and severe).

II. To establish the maximum tolerated dose (MTD) and appropriate dosing recommendations for romidepsin in such patients.

III. To characterize the pharmacokinetics (PK) of romidepsin in patients with varying degrees of liver dysfunction.

SECONDARY OBJECTIVES:

I. To explore correlations of the Child-Pugh classification of liver dysfunction with the observed toxicities and plasma PK of romidepsin administration.

II. To document any preliminary evidence of antitumor activity at tolerable doses of romidepsin in patients with varying degrees of liver dysfunction.

OUTLINE: This is a dose-escalation study.

Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) lymphoma, chronic lymphocytic lymphoma (CLL) or solid tumor; patients with lymphoma or CLL must have radiologically or clinically evaluable disease, and be refractory to standard therapy as defined by relapse within 6 months of last treatment (see note below); patients with solid tumors must have radiologically or clinically evaluable disease that is metastatic, unresectable, progressive, or recurrent, and for which standard curative measures do not exist or are no longer effective

    • Patients with a liver mass, raised alpha-fetoprotein level (>= 500 ng/mL) and positive serology for hepatitis, consistent with a diagnosis of hepatocellular carcinoma will be eligible without the need for pathologic confirmation of the diagnosis
    • Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase 2 studies; patients with breast, pancreatic, bladder, head and neck cancers, as well as melanoma and other malignancies are eligible
    • Note: patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts provided the patients:

      • Sign a separate consent form which outlines the lack of efficacy observed in prior studies
      • Are consented to the study by a protocol-specified designee who is not their longitudinal oncologist; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts
    • Note: as romidepsin is approved for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL), these patients would be eligible WITHOUT the requirement of having 'relapsed within 6 months of last treatment'
  • Life expectancy of > 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Hemoglobin >= 9 g/dL (transfusions and/or erythropoietin are permitted)
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L (or platelet count >= 30 × 10^9 cells/L in patients with lymphoma or CLL if bone marrow disease involvement is documented)
  • Creatinine =< twice upper limit institutional normal
  • Patients with abnormal liver function will be eligible and will be grouped according to the criteria below

    • Group A (normal hepatic function)

      • Bilirubin =< upper limit of normal (ULN) and aspartate aminotransferase (AST) =< ULN
    • Group B (mild hepatic dysfunction)

      • B1: bilirubin =< ULN and AST > ULN
      • B2: bilirubin > ULN but =< 1.5 x ULN and any AST
    • Group C (moderate hepatic dysfunction)

      • Bilirubin > 1.5 x ULN to =< 3 x ULN and any AST
    • Group D (severe hepatic dysfunction)

      • Bilirubin > 3 x ULN and up to investigators discretion and any AST
    • Patients with active hemolysis should be excluded; no distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes; registration laboratory investigations will be used to assign a patient to a hepatic function group; liver function tests should be repeated within 24 hours prior to starting initial therapy and may result in the patients' group assignment being altered if different to registration test results
  • Patients with brain metastases who require corticosteroids or non-enzyme inducing anticonvulsants must be on a stable dose of corticosteroids and seizure free for 1 month prior to enrollment; patients with known brain metastases should have completed brain irradiation (whole brain or gamma knife) more than 4 weeks before starting the protocol; patients on enzyme inducing anticonvulsants are not eligible; note that patients should have had their steroids tapered to low dose (i.e. < 1.5 mg of dexamethasone/day) due to the potential for higher dexamethasone doses to induce cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)
  • Patients with biliary obstruction for which a stent has been placed are eligible, provided the shunt has been in place for at least 10 days prior to the first dose of romidepsin and the liver function has stabilized; two measurements at least 2 days apart that put the patient in the same hepatic dysfunction stratum will be accepted as evidence of stable hepatic function; there should be no evidence of biliary sepsis
  • Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or PK of romidepsin will be determined following review of their case by the site principal investigator

    • Patients treated with any of the medications prohibited must discontinue their use at least 7 days prior to the first dose of romidepsin; certain other agents that interact with the CYP3A4 system may be used with caution
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; note: since romidepsin binds to the estrogen receptor, the effectiveness of estrogen containing contraceptives may be reduced
  • Human immunodeficiency virus (HIV)-positive patients who are not receiving: agents with the potential for PK interactions with romidepsin or hepatotoxic antiretrovirals (nucleoside reverse-transcriptase inhibitors [NRTIs]: abacavir, didanosine, emtricitabine, lamivudine, stavudine, and zidovudine), dual protease inhibitor (PI)-based regimens except low-dose boosting with ritonavir, atazanavir, indinavir, maraviroc, and nevirapine may be eligible; additionally, the HIV-positive patients should have a cluster of differentiation (CD)4 count > 250/mm^3; if the specific cause of hepatic dysfunction is unknown, the patient should be worked up for other viral causes of hepatitis and their eligibility determined after consultation with the principal investigator
  • Patients who have received prior romidepsin use are eligible
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had (prior to entering the study): major surgery is not permitted within 4 weeks of romidepsin administration; anti-cancer therapy including chemotherapy, radiotherapy, hormonal (with the exception of hormones for thyroid conditions), and other investigational agents will not be allowed within 14 days or five (5) half-lives (whichever is longer) prior to the first dose of romidepsin (6 weeks for nitrosoureas or mitomycin C); additionally, participants must have recovered to less than grade 2 clinically significant adverse effect(s)/toxicity(ies) of the previous therapy, with the exception of alopecia, unless approved by the principal investigator; biologics or immunotherapy will not be allowed within 28 days prior to, or during, romidepsin administration
  • Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma, and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase 2 studies; patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts only; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to romidepsin, including cyclic tetrapeptide compounds
  • Concurrent medications associated with a risk of corrected QT interval (QTc) prolongation and/or Torsades de Pointes are not allowed within 2 weeks of initiation of study treatment; those medications as reported but lacking substantial evidence for causing QTc prolongation and Torsades de Pointes will be allowed, although if an alternative medication can be substituted, that would be preferable
  • Thiazolidinedione agents such as rosiglitazone and pioglitazone are not permitted
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with current evidence of significant cardiovascular disease (New York Heart Association class III or IV cardiac disease), symptomatic congestive heart failure, dilated/hypertrophic or restrictive cardiomyopathy, myocardial infarction (within the past 6 months), unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of medications for rate control for atrial fibrillation is allowed such as calcium channel blockers and beta-blockers, if stable medication for at least last month prior to initiation of romidepsin treatment and medication not listed as causing Torsades de Pointes), or evidence of acute ischemia on electrocardiogram (ECG); marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 450 msec*; long QT syndrome; the required use of concomitant medication that may cause Torsades de Pointes or may cause a significant prolongation of the QTc

    • Note: due to difficulties assessing QTc in patients with heart block, they may be eligible if deemed safe by a cardiologist
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with this drug
  • Warfarin is not permitted
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638533

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Vincent Chung    626-471-9200    vchung@coh.org   
Principal Investigator: Vincent Chung         
University of California at Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Karen L. Kelly    916-734-3735    karen.kelly@ucdmc.ucdavis.edu   
Principal Investigator: Karen L. Kelly         
City of Hope South Pasadena Recruiting
South Pasadena, California, United States, 91030
Contact: Stephen C. Koehler    626-396-2900    skoehler@cohmg.com   
Principal Investigator: Stephen C. Koehler         
United States, Maryland
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Roisin M. Connolly    410-614-9217    rconnol2@jhmi.edu   
Principal Investigator: Roisin M. Connolly         
National Cancer Institute Developmental Therapeutics Clinic Recruiting
Bethesda, Maryland, United States, 20892
Contact: Roisin M. Connolly    410-614-9217    rconnol2@jhmi.edu   
Principal Investigator: Roisin M. Connolly         
United States, Michigan
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Ulka N. Vaishampayan    313-576-8718    vaishamu@karmanos.org   
Principal Investigator: Ulka N. Vaishampayan         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Paul Haluska    507-284-2511    haluska.paul@mayo.edu   
Principal Investigator: Paul Haluska         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Afshin Dowlati    216-844-1228    axd44@case.edu   
Principal Investigator: Afshin Dowlati         
United States, Pennsylvania
Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Chandra P. Belani    717-531-1078    cbelani@psu.edu   
Principal Investigator: Chandra P. Belani         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Roisin M. Connolly    410-614-9217    rconnol2@jhmi.edu   
Principal Investigator: Roisin M. Connolly         
Canada, Ontario
University Health Network-Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Lillian L. Siu    416-946-2911    lillian.siu@uhn.ca   
Principal Investigator: Lillian L. Siu         
Sponsors and Collaborators
Investigators
Principal Investigator: Roisin Connolly Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01638533     History of Changes
Other Study ID Numbers: NCI-2012-01040, NCI-2012-01040, NCI-2013-01545, CDR0000737061, J11105, 9008, UM1CA186690, U01CA132123, U01CA062505, U01CA070095, U01CA069912, UM1CA186686, UM1CA186691, UM1CA186717, P30CA006973, UM1CA186644
Study First Received: July 9, 2012
Last Updated: November 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Hairy Cell
Leukemia, Large Granular Lymphocytic
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, B-Cell
Adenocarcinoma, Follicular
Astrocytoma
Brain Neoplasms
Breast Neoplasms
Breast Neoplasms, Male
Burkitt Lymphoma
Carcinoid Tumor
Carcinoma
Carcinoma, Adenoid Cystic
Carcinoma, Basal Cell
Carcinoma, Islet Cell
Carcinoma, Medullary
Carcinoma, Merkel Cell
Carcinoma, Mucoepidermoid
Carcinoma, Neuroendocrine
Carcinoma, Non-Small-Cell Lung
Carcinoma, Papillary
Carcinoma, Renal Cell
Carcinoma, Squamous Cell
Carcinoma, Verrucous
Colonic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014