Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma

NCT ID: NCT02341209

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2021-02-06

Brief Summary

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

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.

Conditions

Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Doxycycline monohydrate

Intervention Type: DRUG

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

Interventions

Doxycycline monohydrate

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

Intervention Type: DRUG

Other Intervention Names

Adoxa, Mondox

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rochester General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brian Poligone, MD, PhD

Scientist II

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Poligone, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rochester General Hospital

Locations

Rochester General Hospital

Rochester, New York, United States

Countries

United States

Other Identifiers

53677

Identifier Type: -

Identifier Source: org_study_id