Clinical Trials /

Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma

NCT02341209

Description:

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

Related Conditions:
  • Primary Cutaneous T Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma
  • Official Title: Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 53677
  • NCT ID: NCT02341209

Conditions

  • Cutaneous T-cell Lymphoma
  • Mycosis Fungoides
  • Sezary Syndrome

Interventions

DrugSynonymsArms
Doxycycline monohydrateAdoxa, MondoxDoxycycline monohydrate

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Doxycycline monohydrateExperimentalDoxycycline 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.
  • Doxycycline monohydrate

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Rochester General Hospital

Trial Keywords

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

Last Updated

October 8, 2019