Status:
TERMINATED
Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Purdue University
Conditions:
Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Eligibility:
All Genders
18+ years
Phase:
NA
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 my...
Detailed Description
The purpose of this study is to find out if the laser light-based imaging test called Biodynamic imaging (BDI) can correctly predict the response of cutaneous T-cell lymphoma mycosis fungoides cancer ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03789864
Start Date
October 7 2019
End Date
May 1 2024
Last Update
May 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University School of Medicine, Department of Dermatology
Indianapolis, Indiana, United States, 46202