Establishing of Neuronal-like Cells From Patients With Cisplatin-Induced Peripheral Neuropathy

February 27, 2018 updated by: Costantine Albany
This study targets patients with cisplatin-induced peripheral neuropathy and will allow us to: a) study peripheral neuropathy in diverse human sensory neurons in ways that were not possible previously; b) gain insight on druggable targets to treat or prevent this devastating side effect of chemotherapy; c) provide a human cellular model that can be used for screening of drugs to determine if they are neurotoxic. The combination of patient information and in vitro measurements provides a highly relevant and clinically useful model for studies aimed to impact treatment selection for the individual cancer patient.

Study Overview

Detailed Description

Primary Objective-To establish a biobank of specimens that allows for the future creation of iPS cells with the potential to make human neurons for functional studies of specific genes/genetic variants.

Secondary Objectives-To develop a clinically relevant in vitro model of cisplatin induced peripheral neuropathy to be used to 1) screen new drugs for the treatment or prevention of peripheral neuropathy; 2) evaluate candidate genes for their role in cisplatin induced neuropathy.

Study Procedures-Subjects who wish to participate will undergo the following study procedures, which will be performed after the informed consent document is obtained:

  1. Sample Collection-A trained phlebotomist will conduct a blood draw for the collection of SIX samples for peripheral blood mononuclear cell (PBMC) isolation and infectious disease testing.
  2. Patient Self-Report of Toxicities-All patients in the study will be asked to fill out the Patient-reported Toxicity Form. This will take approximately 10 minutes to complete and consists of 20 questions related to patient symptoms describing toxicities experienced secondary to receiving cisplatin chemotherapy. They will be asked to fill out the form twice: (1) describing the peripheral neuropathy they currently are experiencing and (2) describing the worst peripheral neuropathy toxicity they experienced as a result of cisplatin therapy. These paper forms will be filled out at time of enrollment in the study.
  3. Physician Report of Toxicities-The patient's physician or the designatee will complete an adverse event form at day of enrollment detailing the physician's assigned grade of toxicities (according to CTCAE version 4.3) experienced from cisplatin. Other information regarding the particularly severe neurotoxicity may also be collected from physicians (e.g. patient use of walker or wheelchair, patient application for disability based on neuropathy).
  4. General Information- This information will be collected at the same time point as all of the other study procedures (i.e., Day One). This will include but may not be limited to: age, height, weight, patient-identified race and ethnicity, information about the chemotherapy regimen, total cisplatin dose administered and date of last cisplatin dose.
  5. Cisplatin Dose-Total cumulative dose of cisplatin administered will be recorded. Outside records will be obtained where needed.
  6. Follow-up and Duration of Follow-Up-There will be no subsequent patient follow-up after time of enrollment. Subjects may withdraw consent for specimen use by contacting the PI in writing.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Simon Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

This study will consist of two groups: testicular cancer patients with severe neuropathy (experimental group) and testicular cancer patients without neuropathy (control group). One control subject will be recruited for each experimental subject with severe neurotoxicity. Controls will be matched based on age (within 10 years), tumor type, race, ethnicity, and chemotherapy regimen and cumulative dose of cisplatin during which the toxicity occurred.

Description

Inclusion Criteria---Severe Toxicity Group

  1. Diagnosis of testicular cancer
  2. Age ≥ 18 years at the time of informed consent
  3. Male
  4. History of any grade 3 or higher peripheral neuropathy after receiving standard dose cisplatin completed more than 1 year but within the last 5 years
  5. Long-term persistence (> 6 months) of grade 2 or higher peripheral neuropathy after completion of a cisplatin containing regimen.
  6. Patient understands the nature of the study and provides written informed consent

Inclusion Criteria---Control Group

  1. Diagnosis of testicular cancer
  2. Age ≥ 18 years
  3. Male
  4. No history of neurotoxicity (grade 0-1) after completion of a standard cisplatin-containing chemotherapy regimen completed more than 1 year but within the last 5 years
  5. Matched to a specified subject with neurotoxicity based on age (within 10 years), chemotherapy regimen or total cisplatin dosage
  6. Patient understands the nature of the study and provides informed consent

Exclusion Criteria (Both groups)

  1. Treatment with other severely neurotoxic chemotherapy prior to or concomitantly with cisplatin.
  2. Presence of peripheral neuropathy prior to cisplatin therapy
  3. Poorly controlled or insulin-dependent diabetes or other conditions likely to predispose neurotoxicity (alcoholism, Charcot-Marie-Tooth disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe Toxicity Group
Diagnosis of testicular cancer; History of any grade 3 or higher peripheral neuropathy after receiving standard dose cisplatin completed more than 1 year but within the last 5 years; Long-term persistence (> 6 months) of grade 2 or higher peripheral neuropathy after completion of a cisplatin containing regimen. Interventions: blood sample collection and report of peripheral neuropathy after cisplatin therapy.
Six tubes of blood will be collected during one blood draw.
Twenty questions about the peripheral neuropathy the patient is currently experiencing, and twenty questions about the worst peripheral neuropathy the patient ever experienced after cisplatin treatment.
Control Group
Diagnosis of testicular cancer; No history of neurotoxicity (grade 0-1) after completion of a standard cisplatin-containing chemotherapy regimen completed more than 1 year but within the last 5 years; Matched to a specified subject with neurotoxicity based on age (within 10 years), chemotherapy regimen or total cisplatin dosage. Interventions: blood sample collection and report of peripheral neuropathy after cisplatin therapy.
Six tubes of blood will be collected during one blood draw.
Twenty questions about the peripheral neuropathy the patient is currently experiencing, and twenty questions about the worst peripheral neuropathy the patient ever experienced after cisplatin treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biobank of peripheral blood mononuclear cells (PBMCs)
Time Frame: Once (at enrollment)
PBMCs will be used for the future creation of iPS cells with the potential to make human neurons
Once (at enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Costantine Albany, MD, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (ESTIMATE)

July 8, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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