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Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides (BDI)

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ClinicalTrials.gov Identifier: NCT03789864
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Purdue University
Information provided by (Responsible Party):
Lawrence Mark, Indiana University

Brief Summary:
This is a single-arm, non-randomized feasibility study designed to find out if the laser light-based imaging test called Biodynamic imaging (BDI) can correctly predict the cutaneous T-cell lymphoma mycosis fungoides (MF) cancer response to chemotherapy treatment. The primary objective is to develop phenotypic profiles of response and non-response to gemcitabine, given at a standard-of-care dose and schedule. A secondary objective is to perform a cross-species analysis of phenotypic responses of human and canine mycosis fungoides to gemcitabine using biodynamic imaging. The study will seek to enroll 10 patients with MF who are planning to receive treatment with gemcitabine given at a standard-of-care (SOC) dose and schedule at Indiana University Simon Cancer Center (IUSCC). All subjects will undergo standardized staging tests, with tumor stage defined according to established guidelines. For the study, three 6-mm x 4-mm dermal punch biopsies from one or more target lesions will be collected prior to treatment initiation and sent to Purdue University researchers for BDI. Objective response for tumor samples treated with gemcitabine in the laboratory will be assessed. Patients with an objective response of complete response (CR) or partial response (PR) that persists during the first 2 treatment cycles will be considered to have responsive cancers, while those failing to meet these criteria will be considered to have resistant cancers. All patients will be considered off-study after completing cycle 2. Accrual is expected to last approximately 24 months.

Condition or disease Intervention/treatment
Lymphoma, T-Cell, Cutaneous Mycosis Fungoides Diagnostic Test: single-arm, non-randomized Biodynamic imaging (BDI)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Analysis of Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy for Human and Canine Mycosis Fungoides
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : July 31, 2021


Group/Cohort Intervention/treatment
single-arm, non-randomized Biodynamic imaging (BDI)
Single-arm, non-randomized, Biodynamic phenotypic profiling of cancer (specifically, mycosis fungoides) therapy, gemcitabine . Standard of Care treatment with gemcitabine in this setting is 1200 mg/m2 as a 30 minute infusion given intravenously on days 1, 8, and 15 of every 28-day treatment cycle. Standard dose reductions are expected in patients experiencing unacceptable toxic effects of treatment. All subjects will undergo standardized staging tests, with tumor stage defined according to established guidelines. For this study, three 6-mm x 4-mm dermal punch biopsies from one or more target lesions will be collected prior to treatment initiation and submitted for Biodynamic imaging (BDI). All patients will be considered off-study after completing cycle 2.
Diagnostic Test: single-arm, non-randomized Biodynamic imaging (BDI)
Skin punch biopsy samples from cutaneous lesions will be profiled for sensitivity to gemcitabine using ex vivo Biodynamic imaging (BDI). The primary clinical outcome assessed will be objective response to chemotherapy after 2 cycles of treatment.
Other Name: mycosis fungoides




Primary Outcome Measures :
  1. Number of Participants with an objective clinical response of MF to gemcitabine chemotherapy [ Time Frame: After the completion of 2 cycles of treatment for each study participant, i.e. after day 56 of study for each individual participant ]
    Patients will be classified as responders versus non-responders based on well defined measures of complete response (responder), partial response (responder), stable disease (non-responder) or progressive disease (non-responder) as outlined in the study protocol.

  2. Number of Participants with phenotypic ex-vivo tumor cell response to gemcitabine chemotherapy [ Time Frame: Day 1 of study for each individual participant ]
    Intracellular motion patterns (biodynamic profiles) are measured by biodynamic imaging technique. Biodynamic profiles associated with poor intercellular organelle motility will be classified as phenotypic responders.


Secondary Outcome Measures :
  1. Percent of individual biodynamic profiles with cellular response (outcome 2) correlating with individual clinical response (outcome 1). [ Time Frame: After day 56 of study for each individual participant ]
    Correlation against discrete patient outcome classifications (response vs. non-response) will be made to individual biodynamic profiles associated with cellular response vs. non-response.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects ≥ 18 years of age at the time of informed consent with histologically confirmed diagnosis of mycosis fungoides (MF) T-cell lymphoma who are planning to receive treatment with gemcitabine given at a standard-of-care (SOC) dose and schedule.
Criteria

Inclusion Criteria:

  1. Ability to provide written informed consent and HIPAA authorization
  2. Male and female subjects ≥ 18 years of age at the time of informed consent
  3. Histologically confirmed diagnosis of mycosis fungoides (MF) T-cell lymphoma
  4. Advanced disease as defined by Stage IB (is when ten percent or more of the skin surface is covered with patches, papules, and/or plaques), II-A, II-B, III and IV; disease unresponsive to or contraindicated for skin directed therapy (light treatment, electron beam radiation, topical nitrogen mustards, topical steroids); or otherwise a candidate for systemic therapy due to disease progression
  5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  6. Post 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 4.03 (NCI-CTCAE, v.4.03)
  7. Adequate hematologic and metabolic functions to tolerate gemcitabine.

Exclusion Criteria:

  1. Lack of enough skin disease burden to adequately obtain 3 6-mm skin biopsies for ex vivo BDI assessment.
  2. Clinical evidence of central nervous system (CNS) metastasis.
  3. Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements
  4. Inability or refusal to receive systemic therapy with gemcitabine
  5. Prior treatment with gemcitabine
  6. Pre-existing allergy to or otherwise contraindicated to receive gemcitabine
  7. Patients not on a stable dose of systemic corticosteroid for at least 4 weeks prior to study entry or ≥ 20 mg prednisone daily equivalent
  8. Subjects actively on other systemic therapeutic agents for cancer including MF, or would reasonably be expected to receive such treatments during the study period, including ≥ 20 mg prednisone equivalent

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): NCT03789864


Contacts
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Contact: Lawrence A Mark, MD,PhD 317-274-7705 lamark@iu.edu
Contact: Flossy Lincoln, MPH,CCRP 317-274-8750 fnjinimb@iupui.edu

Locations
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United States, Indiana
Indiana University School of Medicine, Department of Dermatology Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lawrence A Mark, MD, PhD    317-274-7705    lamark@iu.edu   
Contact: Flossy Lincoln, MPH, CCRP    3172748750    fnjinimb@iupui.edu   
Principal Investigator: Lawrence A Mark, MD, PhD         
Sub-Investigator: Kristin E Hoffmann, MD         
Sub-Investigator: Jose M Azar, MD         
Sub-Investigator: Uptal P Davé, MD         
Sub-Investigator: Michael J Robertson, MD         
Sponsors and Collaborators
Indiana University
Purdue University
Investigators
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Principal Investigator: Lawrence A Mark, MD, PhD Indiana University

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Responsible Party: Lawrence Mark, Charles W. Lewis Investigator and Assistant Professor of Dermatology , Wishard Dermatology Service Chief, Indiana University
ClinicalTrials.gov Identifier: NCT03789864     History of Changes
Other Study ID Numbers: 1804939675
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawrence Mark, Indiana University:
Lymphoma
Additional relevant MeSH terms:
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Mycoses
Mycosis Fungoides
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs