Doxycycline for the Treatment of Cutaneous T-Cell Lymphoma

NCT02341209 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 53677
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cutaneous T-cell Lymphoma; Mycosis Fungoides; Sezary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Efficacy of Doxycycline in relapsed CTCL

  Overall response rate will be determined after five months or a year from initiation of therapy.

  From baseline to five month or a year depending on response.

Secondary Outcomes (1)

• Duration of Response

  From baseline to up to one year.

Other Outcomes (2)

• Quality of Life evaluation

  Baseline to up to one year.

• Pruritus (Itchiness) evaluation

  Baseline to up to one year.

Study Arms (1)

Doxycycline monohydrate

EXPERIMENTAL

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

Interventions

Doxycycline monohydrate DRUG

Doxycycline will be administered in either tablets or capsules for either five months or a year depending on response.

Also known as: Adoxa, Mondox

Doxycycline monohydrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rochester General Hospital: lead

Study Sites (1)

Rochester General Hospital

Rochester, New York, 14621, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Brian Poligone, M.D. Ph.D.

  Rochester General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist II

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: January 19, 2015
• Study Start: February 6, 2018
• Primary Completion: February 6, 2021
• Study Completion: February 6, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)