Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
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|ClinicalTrials.gov Identifier: NCT02341209|
Recruitment Status : Terminated (Low enrollment)
First Posted : January 19, 2015
Last Update Posted : April 27, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome||Drug: Doxycycline monohydrate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Doxycycline in Patients With Relapsed Cutaneous T-cell Lymphoma|
|Actual Study Start Date :||February 6, 2018|
|Actual Primary Completion Date :||February 6, 2021|
|Actual Study Completion Date :||February 6, 2021|
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
- 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.
- 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.
- 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.
- Pruritus (Itchiness) evaluation [ Time Frame: Baseline to up to one year. ]Changes in quality of life will be measured throughout the study using questionnaires.
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|
- 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.
- 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.
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
|United States, New York|
|Rochester General Hospital|
|Rochester, New York, United States, 14621|
|Principal Investigator:||Brian Poligone, M.D. Ph.D.||Rochester General Hospital|
|Responsible Party:||Brian Poligone, MD, PhD, Scientist II, Rochester General Hospital|
|Other Study ID Numbers:||
|First Posted:||January 19, 2015 Key Record Dates|
|Last Update Posted:||April 27, 2021|
|Last Verified:||April 2021|
|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|
Sezary Syndrome (SS)
Mycosis Fungoides (MF)
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Immune System Diseases
Bacterial Infections and Mycoses