CTCL: Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma

Sponsor
Rochester General Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT02341209
Collaborator
(none)
1
Enrollment
1
Location
1
Arm
36
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • 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
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 :
Feb 6, 2018
Actual Primary Completion Date :
Feb 6, 2021
Actual Study Completion Date :
Feb 6, 2021

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Efficacy of Doxycycline in relapsed CTCL [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 [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 [Baseline to up to one year.]

      Changes in quality of life will be measured throughout the study using questionnaires.

    2. Pruritus (Itchiness) evaluation [Baseline to up to one year.]

      Changes in quality of life will be measured throughout the study using questionnaires.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    SiteCityStateCountryPostal Code
    1Rochester General HospitalRochesterNew YorkUnited States14621

    Sponsors and Collaborators

    • Rochester General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brian Poligone, MD, PhD, Scientist II, Rochester General Hospital
    ClinicalTrials.gov Identifier:
    NCT02341209
    Other Study ID Numbers:
    • 53677
    First Posted:
    Jan 19, 2015
    Last Update Posted:
    Apr 27, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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, Scientist II, Rochester General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 27, 2021