CTCL Directed Therapy

Status Recruiting

Clinical Trial Summary

Cutaneous lymphomas are rare cancers of lymphocytes (white blood cells) that involve the skin. Mycosis Fungoides (MF) is the most common type of Cutaneous T-cell lymphoma (CTCL) that typically presents with red, scaly patches that often mimic eczema or chronic dermatitis. The incidence of MF is about 1/100,000. Skin lesions tend to appear before the diagnosis of CTCL is made by several years. Early skin lesions may look like any dermatitis, eczema, or psoriasis, leading to delays in the diagnosis.

Inflammation secondary to bacterial infection is thought to contribute to the T-cell proliferation in this type of cutaneous T-cell lymphoma. Antibiotic use for other purposes has shown to reduce the inflammation and size of lesions in CTCL patients. There has been limited studies with the use of antibiotics as direct treatment for this cancer.

Host immunity is important in decreasing cancer development and progression. Imiquimod is a molecule that stimulates host immunity to reduce the progression of CTCL. There is strong evidence of clinical efficacy such that the National Comprehensive Cancer Network (NCCN) guidelines recommend Imiquimod for CTCL. Imiquimod is available in generic form, making it unlikely to be registered specifically for CTCL, despite its efficacy.

Additionally, imiquimod is considered a first line treatment according to National Comprehensive Cancer Network (NCCN) guidelines for the treatment of Mycosis Fungoides.

There are currently no studies that have been published that address treating CTCL patients with a combined approach of 1) decreasing inflammation caused by bacterial with antibiotics, and 2) enhancing the host immune system to destroy cancer cells. Our theory is if we treat patient with 14days of antibiotics and 30 days of Imiquimod there will be significant reduction in skin lesions.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03116659
Study type	Interventional
Source	James J. Peters Veterans Affairs Medical Center
Contact	Ali Dana, MD
Phone	718-584-9000
Email	Ali.Dana@VA.gov
Status	Recruiting
Phase	Early Phase 1
Start date	February 1, 2018
Completion date	December 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03357224` - PARCT: Trial of Atezolizumab in Relapsed/Refractory Cutaneous T Cell Lymphoma (CTCL)	Phase 2
Completed	`NCT02567656` - Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma	Phase 1
Completed	`NCT00051012` - Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients	Phase 4
Recruiting	`NCT03646422` - AEDV Registry of Primary Cutaneous Lymphoma
Terminated	`NCT03789864` - Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides	N/A
Active, not recruiting	`NCT04998331` - A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin
Active, not recruiting	`NCT02953301` - Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)	Phase 2
Completed	`NCT01486277` - A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma	Phase 2
Completed	`NCT01433731` - Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)	Phase 1
Completed	`NCT05137847` - A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
Active, not recruiting	`NCT03902184` - IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma	Phase 2
Completed	`NCT00896493` - Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma	Phase 2
Completed	`NCT00211198` - Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)	Phase 4
Terminated	`NCT03601819` - Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders	Phase 1
Withdrawn	`NCT03742804` - Study Of Intratumoral G100 In Cutaneous T Cell Lymphoma	Phase 2
Completed	`NCT02836886` - VircapSeq Virus Detection in Sézary Syndrome
Completed	`NCT00050999` - Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients	Phase 4
Terminated	`NCT02323659` - Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas	Phase 4
Recruiting	`NCT02840747` - Tissue Repository: CTCL Collection Protocol
Completed	`NCT03192202` - AFM13 in Relapsed/Refractory Cutaneous Lymphomas	Phase 1/Phase 2