Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma

Mycosis Fungoides Clinical Trial

— CTCL  

Official title:

Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02341209
• Other study ID #: 53677
• Status: Terminated
• Phase: Phase 2
• Start date: February 6, 2018
• Est. completion date: February 6, 2021

Study information

• Verified date: April 2021
• Source: Rochester General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 6, 2021
• Est. primary completion date: February 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous T-cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides
• Sezary Syndrome

Intervention

Drug:
• Doxycycline monohydrate
Doxycycline will be administered in either tablets or capsules for either five months or a year depending on response.

Locations

Country	Name	City	State
United States	Rochester General Hospital	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rochester General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life evaluation	Changes in quality of life will be measured throughout the study using questionnaires.	Baseline to up to one year.
Other	Pruritus (Itchiness) evaluation	Changes in quality of life will be measured throughout the study using questionnaires.	Baseline to up to one year.
Primary	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	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.