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

• ClinicalTrials.gov Identifier: NCT02341209
• Recruitment Status: Terminated
• First Posted: January 19, 2015
• Last Update Posted: April 27, 2021
• Sponsor: Rochester General Hospital
• Information provided by (Responsible Party): Brian Poligone, MD, PhD, Rochester General Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome	Drug: Doxycycline monohydrate	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Open Label
• Primary Purpose: Treatment
• Official Title: Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma
• Actual Study Start Date: February 6, 2018
• Actual Primary Completion Date: February 6, 2021
• Actual Study Completion Date: February 6, 2021

Arms and Interventions

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 Name: Adoxa, Mondox

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Duration of Response [ Time Frame: From baseline to up to one year. ]
   Patients who achieve a Partial Response or Complete Response will be monitored for progression up to one year after initiation of therapy.

Other Outcome Measures:

1. Quality of Life evaluation [ Time Frame: Baseline to up to one year. ]
   Changes in quality of life will be measured throughout the study using questionnaires.
2. Pruritus (Itchiness) evaluation [ Time Frame: Baseline to up to one year. ]
   Changes in quality of life will be measured throughout the study using questionnaires.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, New York

Rochester General Hospital

Rochester, New York, United States, 14621

Sponsors and Collaborators

Rochester General Hospital

Investigators

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

More Information

• Responsible Party: Brian Poligone, MD, PhD, Scientist II, Rochester General Hospital
• ClinicalTrials.gov Identifier: NCT02341209
• Other Study ID Numbers: 53677
• First Posted: January 19, 2015
• Last Update Posted: April 27, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: As required

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian Poligone, MD, PhD, Rochester General Hospital:

CTCL; Sezary Syndrome (SS); Mycosis Fungoides (MF); Cutaneous T-cell Lymphoma; MF; SS

Additional relevant MeSH terms:

Mycoses; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Bacterial Infections and Mycoses; Infections; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents