Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma

This study looks at the efficacy of Doxycycline for the treatment of Cutaneous T-cell Lymphomas.

Study Overview

• Status: Terminated
• Conditions: Mycosis Fungoides; Sezary Syndrome; Cutaneous T-cell Lymphoma
• Intervention / Treatment: Drug: Doxycycline monohydrate

Detailed Description

The aim of this study is to evaluate the efficacy of doxycycline in relapsed Cutaneous T-cell Lymphomas (CTCL). The primary objective is to determine the overall response rate of doxycycline monotherapy in patients with relapsed CTCL.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14621
      • Rochester General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines. Written informed consent must be obtained prior to performing any study-related procedure.
• Be 18 years of age or older at time of enrollment.
• Measurable disease in at least one target lesion in the skin or able to be assessed by radiographic examination with FDG-PET fluorodeoxyglucose possitron emission tomography (FDG-PET) scan or computarized tomography (CT) scan, or peripheral blood showing involvement of lymphoma.
• The subject has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0) excluding the specification below.
• Adequate organ function:
• Absolute Neutrophil Count (ANC) > 500 cells/mL and platelet count > 50,000 cells/mL unless felt to be secondary to lymphoma at which any count is permissible.
• Adequate renal function as determined by creatinine < 1.5x upper limit normal (ULN) or estimated creatinine clearance of ≥ 60ml/min
• Adequate hepatic function as determined by total bilirubin < 1.5x ULN (unless known Gilbert syndrome), Alanine transaminase (ALT) and Aspartate transaminase (AST) < 2.5x ULN
• Confirmed diagnosis of CTCL.
• Karnofsky Performance Status ≥ 60%
• Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication and monthly while on receiving doxycycline
• WOCBP must agree to use effective contraception, defined as, oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse (periodic abstinence, e.g., calendar ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 3 months after the last dose. WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months without an alternative medical cause).
• Male subjects and their female partners of child bearing potential must be willing to use an appropriate method of contraception defined as, oral contraceptives, double barrier method (condom plus spermicide or diaphragm plus spermicide) or practice true abstinence from sexual intercourse (periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception) during the study and for 3 months after the last dose.

Exclusion Criteria:

• Known sensitivity or allergy to tetracyclines
• Lack of measurable disease
• Karnofsky Performance Status <60%
• Inadequate organ function as measured by not fulfilling above criteria
• Subject is pregnant or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doxycycline monohydrate; Doxycycline in either capsules or tablets will be administered at 400mg total per day. Patients will be treated for five months, or up to one year for those with a partial response at 5 months.	Drug: Doxycycline monohydrate; Doxycycline will be administered in either tablets or capsules for either five months or a year depending on response.; Other Names: Adoxa, Mondox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Doxycycline in relapsed CTCL	Overall response rate will be determined after five months or a year from initiation of therapy.	From baseline to five month or a year depending on response.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response	Patients who achieve a Partial Response or Complete Response will be monitored for progression up to one year after initiation of therapy.	From baseline to up to one year.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life evaluation	Changes in quality of life will be measured throughout the study using questionnaires.	Baseline to up to one year.
Pruritus (Itchiness) evaluation	Changes in quality of life will be measured throughout the study using questionnaires.	Baseline to up to one year.

Collaborators and Investigators

• Sponsor: Rochester General Hospital
• Investigators: Principal Investigator: Brian Poligone, M.D. Ph.D., Rochester General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): February 6, 2021
• Study Completion (Actual): February 6, 2021

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: MF; CTCL; Sezary Syndrome (SS); Mycosis Fungoides (MF); Cutaneous T-cell Lymphoma; SS
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Bacterial Infections and Mycoses; Lymphoma; Mycoses; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: 53677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: As required

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No