ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02341209
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Brian Poligone, MD, PhD, Rochester General Hospital

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

Condition or disease Intervention/treatment Phase
Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : February 6, 2018
Estimated Primary Completion Date : February 6, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/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 Name: Adoxa, Mondox




Primary Outcome Measures :
  1. Efficacy of Doxycycline in relapsed CTCL [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to up to one year. ]
    Changes in quality of life will be measured throughout the study using questionnaires.

  2. Pruritus (Itchiness) evaluation [ Time Frame: Baseline to up to one year. ]
    Changes in quality of life will be measured throughout the study using questionnaires.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341209


Contacts
Contact: Carolina V Alexander-Savino, B.S., CCRC 585-489-2883 carolina.alexander@rochesterregional.org
Contact: Brian Poligone, M.D. Ph.D. 585-364-1188

Locations
United States, New York
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
Contact: Carolina V. Alexander-Savino, B.S.,CCRC    585-489-2883    carolina.alexander@rochesterregional.org   
Contact: Brian Poligone, M.D. Ph.D.    585-364-1188      
Sponsors and Collaborators
Rochester General Hospital
Investigators
Principal Investigator: Brian Poligone, M.D. Ph.D. Rochester General Hospital

Responsible Party: Brian Poligone, MD, PhD, Scientist II, Rochester General Hospital
ClinicalTrials.gov Identifier: NCT02341209     History of Changes
Other Study ID Numbers: 53677
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As required

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, Rochester General Hospital:
CTCL
Sezary Syndrome (SS)
Mycosis Fungoides (MF)
Cutaneous T-cell Lymphoma
MF
SS

Additional relevant MeSH terms:
Mycoses
Mycosis Fungoides
Lymphoma
Lymphoma, T-Cell
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents