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CTCL Directed Therapy

Primary Purpose

Lymphoma, T-Cell, Cutaneous

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
Imiquimod
Sponsored by
James J. Peters Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, T-Cell, Cutaneous

Eligibility Criteria

30 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • James J Peters Bronx Veterans Affairs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 11, 2017
Last Updated
August 12, 2019
Sponsor
James J. Peters Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03116659
Brief Title
CTCL Directed Therapy
Official Title
CTCL Directed Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
James J. Peters Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, T-Cell, Cutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Doxycycline 100 mg PO BID x 14 days
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Intervention Description
up to 2 packs 3/ week x 28 days
Primary Outcome Measure Information:
Title
Pilot assessment of response.
Description
Pilot assessment of response assessed by decreased size or surface change of the 5 lesions
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients age 30 - 89 years old Stages I to II CTCL patients Normal renal function, Cr ≤ 1.5 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Dana, MD
Phone
718-584-9000
Ext
5289
Email
Ali.Dana@VA.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Dana, MD
Organizational Affiliation
James J. Peters VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J Peters Bronx Veterans Affairs Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Dana, MD/PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33851477
Citation
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.
Results Reference
derived

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CTCL Directed Therapy

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