Clinical Trials Actively Recruiting Patients With Cutaneous Lymphoma

Study Type: Observational

Study Title: Peripheral Blood and Skin Sample Collection for Cutaneous Lymphoma Research

Study Sponsor and Collaborators: University of Pittsburgh

Purpose: To create a tissue and blood banking protocol for patients with cutaneous T-cell lymphoma (CTCL) for current and future CTCL research

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Proteomics of Cutaneous T-cell lymphoma (time frame: ongoing)

Principal Investigator: Lisa M. Grandinetti, MD, University of Pittsburgh; contact Sue A. McCann, MSN, RN, 412-864-3681, mccannsa@upmc.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00177268

Study Title: Outcomes of Cutaneous T-Cell Lymphoma and Chronic Graft-Versus-Host Disease in Patients Treated With Extracorporeal Photopheresis

Study Sponsor and Collaborators: Dartmouth-Hitchcock Medical Center

Purpose: To study the outcomes (response rates) of extracorporeal photopheresis (ECP) as a treatment for cutaneous T-cell lymphoma (CTCL) and graft-vs-host disease (GVHD) and other factors relating to their disease and treatment, as well as procedural events, such as complications

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Response rates (time frame: 1 year)

Principal Investigator: Frederick Lansigan, MD, Dartmouth-Hitchcock Medical Center; 800-639-6918, cancer.research.nurse@dartmouth.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01460914

Study Title: Rare and Cutaneous Non-Hodgkin Lymphoma Registry

Study Sponsor and Collaborators: Children’s Oncology Group, National Cancer Institute

Purpose: To collect and store tissue samples from patients with rare or cutaneous non-Hodgkin lymphoma

Ages Eligible for the Study: Up to 21 years

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Clinical features, treatment, and outcomes (time frame: length of study; study ends January 2100)

Principal Investigator: Amanda M. Termuhlen, MD, Nationwide Children’s Hospital; 562-933-8605

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01000753

Study Title: Analysis of Cutaneous and Hematologic Disorders by High-Throughput Nucleic Acid Sequencing

Study Sponsor and Collaborators: Stanford University

Purpose: To identify genetic changes associated with the initiation, progression, and treatment response of cutaneous and hematologic disorders using recently developed high-throughput sequencing technologies

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Number of mutations (time frame: 2 years)

Principal Investigator: Paul Khavari, MD, Stanford University; contact Alexander Ungewickell, 650-723-6661, ungewica@stanford.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01556828

Study Title: Longitudinal Assessment of Ovarian Reserve in Adolescents With Lymphoma

Study Sponsor and Collaborators: Children’s Oncology Group, National Cancer Institute

Purpose: To study blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.

Ages Eligible for the Study: Up to 29 years

Genders Eligible for the Study: Female

Accepts Healthy Volunteers: No

Primary Outcome Measures: Comparison of the measures of ovarian reserve (AMH, FSH, and E2) to that of health controls (time frame: up to 12 months)

Principal Investigator: Jennifer Levine, MD, Children’s Oncology Group; study is multisite and state locations are listed on ClinicalTrials.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01793233

Study Type: Phase I/interventional/single-group assignment

Study Title: Phase I Dose-Escalation Study of CPI-613, in Combination With Bendamustine, in Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma or Classic Hodgkin Lymphoma

Study Sponsor and Collaborators: Comprehensive Cancer Center of Wake Forest University, National Cancer Institute

Purpose: To study the side effects and best dose of CPI-613 when given together with bendamustine hydrochloride in treating patients with relapsed or refractory T-cell non-Hodgkin lymphoma or Hodgkin lymphoma

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Maximum tolerated dose of 6,8-bis(benzylthio)octanoic acid when used in combination with bendamustine hydrochloride, defined as the dose level immediately below the dose level that induced a dose-limiting toxicity in < 2 patients (time frame: up to 28 days)

Principal Investigator: Zanetta S. Lamar, MD, Wake Forest University; 336-716-7448, zlamar@wakehealth.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02168140

Study Title: Silicon Phthalocyanine Pc4 for Photodynamic Therapy of Cutaneous T-cell Lymphoma: Single and Repeated Photoexposures

Study Sponsor and Collaborators: Case Comprehensive Cancer Center, National Cancer Institute

Purpose: To study the side effects and best dose of silicon phthalocyanine 4 and photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin lymphoma

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Maximum tolerated dose defined as the dose immediately below the dose in which two or more of six patients experience a grade 4 toxicity assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (time frame: up to 30 days)

Principal Investigator: Elma D. Baron, MD, Case Comprehensive Cancer Center; 800-641-2422, elma.baron@case.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01800838

Study Title: A Pilot Study of a Novel Multimodality Immuno-Chemotherapy Platform for Patients With Advanced Cutaneous T-Cell Lymphoma

Study Sponsor and Collaborators: New York University School of Medicine, Ludwig Institute for Cancer Research

Purpose: To evaluate the safety and tolerability of the addition of immunostimulatory therapy consisting of focal radiation with or without the Toll-like receptor (TLR) agonist Poly ICLC in patients with cutaneous T-cell lymphoma (CTCL) receiving concurrent therapy with the histone deacetylase inhibitor (HDACI) romidepsin

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Maximum tolerated dose (MTD) (time frame: 21 days)

Principal Investigator: Catherine Diefenbach, MD, New York University School of Medicine; 212-731-5670, catherine.diefenbach@nyumc.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02061449

Study 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

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study the side effects and best dose of romidepsin in treating patients with lymphoma, chronic lymphocytic leukemia, or solid tumors with liver dysfunction

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Maximum tolerated dose 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)

Principal Investigator: Roisin Connolly, Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center; 410-614-9217; rconno12@jhmi.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01638533

Study Title: A Phase I Trial of the Combination of Everolimus (RAD001) and Bortezomib (Velcade) for Relapsed or Refractory Lymphoma

Study Sponsor and Collaborators: National Cancer Institute, The Leukemia and Lymphoma Society

Purpose: To study the side effects and best dose of everolimus when given together with bortezomib in treating patients with relapsed or refractory lymphoma

Ages Eligible for the Study: 18 Years and Older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Maximum tolerated dose of everolimus in combination with bortezomib (time frame: after one course [21 days])

Principal Investigator: Brian Hill, MD, PhD, Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center; 216-444-6833, hillb2@ccf.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00671112

Study Type: Phase II/interventional/single-group assignment

Study Title: Therapeutic Efficacy of Topical Sirolimus in Early-Stage Cutaneous T-cell Lymphoma (CTCL)

Study Sponsor and Collaborators: Medical College of Wisconsin

Purpose: To determine whether sirolimus reduces the symptoms of cutaneous T-cell lymphoma and whether it causes any side effects

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Overall response rate (time frame: 6 months)

Principal Investigator: Stefan Schieke, MD, Medical College of Wisconsin; contact MCW Cancer Center Clinical Trials Office, 414-805-8900, cccto@mcw.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01843998

Study Title: Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma

Study Sponsor and Collaborators: University of Rochester

Purpose: To study the efficacy of doxycycline for the treatment of cutaneous T-cell lymphomas

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Efficacy of doxycycline in relapsed CTCL (time frame: from baseline to 5 months or a year, depending on
response)

Principal Investigator: Brian Poligone, MD, PhD, University of Rochester; contact Carolina V. Alexander Rodriguez, BS, 585-489-2883, carolina_alexander@urmc.rochester.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02341209

Study Title: A Phase II Study of Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Patients with Cutaneous T Cell Lymphoma

Study Sponsor and Collaborators: Stanford University

Purpose: To study hematopoietic stem cell transplantation using a nonmyeloablative preparative regimen, TLI/ATG

Ages Eligible for the Study: 18 years and older

Genders Eligible for the Study: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: To evaluate the graft-vs-lymphoma effect by monitoring the rate of clinical response, event-free, and overall survival (time frame: 2 years)

Principal Investigator: Wen-Kai Wang, MD, PhD, Stanford University; contact Physician Referrals, 650-723-0822

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00896493

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, visit ClinicalTrials.gov. ■