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

Primary Purpose

Cutaneous T-cell Lymphoma, Mycosis Fungoides, Sezary Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Doxycycline monohydrate
Sponsored by
Rochester General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T-cell Lymphoma focused on measuring CTCL, Sezary Syndrome (SS), Mycosis Fungoides (MF), Cutaneous T-cell Lymphoma, MF, SS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rochester General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Doxycycline monohydrate

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy of Doxycycline in relapsed CTCL
Overall response rate will be determined after five months or a year from initiation of therapy.

Secondary Outcome Measures

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.

Full Information

First Posted
November 21, 2014
Last Updated
April 23, 2021
Sponsor
Rochester General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02341209
Brief Title
Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma
Acronym
CTCL
Official Title
Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
February 6, 2021 (Actual)
Study Completion Date
February 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rochester General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
Keywords
CTCL, Sezary Syndrome (SS), Mycosis Fungoides (MF), Cutaneous T-cell Lymphoma, MF, SS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline monohydrate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxycycline monohydrate
Other Intervention Name(s)
Adoxa, Mondox
Intervention Description
Doxycycline will be administered in either tablets or capsules for either five months or a year depending on response.
Primary Outcome Measure Information:
Title
Efficacy of Doxycycline in relapsed CTCL
Description
Overall response rate will be determined after five months or a year from initiation of therapy.
Time Frame
From baseline to five month or a year depending on response.
Secondary Outcome Measure Information:
Title
Duration of Response
Description
Patients who achieve a Partial Response or Complete Response will be monitored for progression up to one year after initiation of therapy.
Time Frame
From baseline to up to one year.
Other Pre-specified Outcome Measures:
Title
Quality of Life evaluation
Description
Changes in quality of life will be measured throughout the study using questionnaires.
Time Frame
Baseline to up to one year.
Title
Pruritus (Itchiness) evaluation
Description
Changes in quality of life will be measured throughout the study using questionnaires.
Time Frame
Baseline to up to one year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Poligone, M.D. Ph.D.
Organizational Affiliation
Rochester General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
As required

Learn more about this trial

Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma

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