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CTCL Directed Therapy

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ClinicalTrials.gov Identifier: NCT03116659
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ali Dana, James J. Peters Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 17, 2017
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
Pilot assessment of response. [ Time Frame: 1 year ]
Pilot assessment of response assessed by decreased size or surface change of the 5 lesions
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03116659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CTCL Directed Therapy
Official Title  ICMJE CTCL Directed Therapy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, T-Cell, Cutaneous
Intervention  ICMJE
  • Drug: Doxycycline
    Doxycycline 100 mg PO BID x 14 days
  • Drug: Imiquimod
    up to 2 packs 3/ week x 28 days
Study Arms  ICMJE Experimental: Single Arm
Doxycycline 100 mg PO BID x 14 days, then Imiquimod up to 2 packs 3/ week x 28 days
Interventions:
  • Drug: Doxycycline
  • Drug: Imiquimod
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ali Dana, MD 718-584-9000 ext 5289 Ali.Dana@VA.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03116659
Other Study ID Numbers  ICMJE DAN-15-028
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ali Dana, James J. Peters Veterans Affairs Medical Center
Study Sponsor  ICMJE James J. Peters Veterans Affairs Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ali Dana, MD James J. Peters VAMC
PRS Account James J. Peters Veterans Affairs Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP