CTCL Directed Therapy

NCT03116659 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: DAN-15-028
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma, T-Cell, Cutaneous

Outcome Measures

Primary Outcomes (1)

• Pilot assessment of response.

  Pilot assessment of response assessed by decreased size or surface change of the 5 lesions

  1 year

Study Arms (1)

Single Arm

EXPERIMENTAL

Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days

Drug: Doxycycline; Drug: Imiquimod

Interventions

Doxycycline DRUG

Doxycycline 100 mg PO BID x 14 days

Single Arm

Imiquimod DRUG

up to 2 packs 3/ week x 28 days

Single Arm

Eligibility Criteria

• Age: 30 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 30 - 89 years old
• Stages I to II CTCL patients
• Normal renal function, Cr ≤ 1.5

You may not qualify if:

• Aggressively progressing CTCL
• Active infection and/or concurrent malignancy
• Poor renal function (Cr \> 1.5)
• Pregnancy (HCG serum +)
• History of bone marrow suppression, MDS, anemia (Hemoglobin \< 8), thrombocytopenia (\< 50,000) or neutropenia (ANC \< 1500)
• CHF, MI within last 6 months
• Endocarditis
• Allergies to Imiquimod or doxycycline

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J Peters Bronx Veterans Affairs Medical Center

The Bronx, New York, 10468, United States

RECRUITING

Related Publications (1)

• Del Guzzo CA, Kojadinovic A, Vinnakota RR, Geskin LJ, Newman JC, Langhoff E, Park YA, Bates SE, Dana AN. Antibiotics and Imiquimod for Cutaneous T-Cell Lymphoma in Veterans: A Patient Population with Agent Orange Exposure. Oncologist. 2021 Sep;26(9):727-e1488. doi: 10.1002/onco.13785. Epub 2021 May 14.

  PMID: 33851477 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

Doxycycline; Imiquimod

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ali Dana, MD

  James J. Peters VAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Dana, MD

CONTACT

718-584-9000; Ali.Dana@VA.gov

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 17, 2017
• Study Start: February 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)