Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides

NCT03789864 | Terminated DMC FDA Device

• 1 other identifier: 1804939675
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides

Keywords

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Development of phenotypic human MF biodynamic profiles

  Dermal punch biopsy samples from subjects' cutaneous mycosis fungoides lesions will be analyzed using ex vivo BDI for sensitivity to gemcitabine. BDI measures intracellular motion patterns (biodynamic profiles) before and after gemcitabine is applied to the sample. Biodynamic profiles associated with poor intercellular organelle motility will be classified as phenotypic responders while those associated with normal intercellular organelle motility will be classified as phenotypic non-responders.

  Biopsy samples are collected and imaged prior to each subject's initiation of standard of care gemcitabine treatment

Secondary Outcomes (1)

• Percent of individual biodynamic profiles with cellular response correlating with individual clinical response.

  After day 56 of study for each individual participant

Study Arms (1)

Individuals undergoing SOC Gemcitabine Treatment for mycosis fungoides (MF) T-cell lymphoma

OTHER

Standard of Care (SOC) 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: Biodynamic imaging (BDI) of mycosis fungoides

Interventions

Biodynamic imaging (BDI) of mycosis fungoides DIAGNOSTIC_TEST

Skin punch biopsy samples from cutaneous lesions will be profiled for sensitivity to gemcitabine using ex vivo Biodynamic imaging (BDI). A biodynamic profile, of either phenotypic responder or phenotypic non-responder, will be assigned.

Individuals undergoing SOC Gemcitabine Treatment for mycosis fungoides (MF) T-cell lymphoma

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent and HIPAA authorization
• Male and female subjects ≥ 18 years of age at the time of informed consent
• Histologically confirmed diagnosis of mycosis fungoides (MF) T-cell lymphoma
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
• 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)
• Adequate hematologic and metabolic functions to tolerate gemcitabine.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator

Study Sites (1)

Indiana University School of Medicine, Department of Dermatology

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Lawrence A Mark, MD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Charles W. Lewis Investigator and Assistant Professor of Dermatology , Wishard Dermatology Service Chief

Model Details: This is a single-arm, single-center, non-randomized feasibility study.

Study Record Dates

• First Submitted: December 8, 2018
• First Posted: December 31, 2018
• Study Start: October 7, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

US (1)