RECRUITING

Treatment of Radiation and Cisplatin Induced Toxicities with Tempol

Conditions

Mucositis Nephrotoxicity Ototoxicity cisplatin toxicity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients. Over the course of the 10 week trial, mucositis, nephrotoxicity, and ototoxicity will be monitored and assessed.

Official Title

A Double Blind, Placebo Controlled Dose Range Finding Study to Assess the Safety, Pharmacokinetics, and Efficacy of Tempol for the Reduction of Severe Mucositis in Head and Neck Cancer Patients Undergoing Combined Radio- and Chemotherapy

Quick Facts

Study Start:2019-05-13

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03480971

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN); 2. Be scheduled to receive radiotherapy or proton therapy administered with a curative intent; 3. If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant; 4. If male and of child bearing potential, adequate methods of contraception must be employed including use of condoms with spermicide. No sperm donation for 90 days until after the conclusion of the study; 5. Must be receiving cisplatin for chemotherapy; 6. Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation; 7. Must have a score 2 or less on the ECOG performance status; 8. Participant life expectancy ≥ 6 months; and 9. Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):	1. Prior radiotherapy of the head and neck; 2. Have a clinically significant infection defined as any acute viral, bacterial or fungal infection, which requires specific therapy. Anti-infectious therapy must have been completed within 14 days of starting study treatment; 3. Be taking any non-approved therapy for oral mucositis, including β-carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-β (transforming growth factor beta), or systemic KGF (keratinocyte growth factor) during or within 14 days of starting treatment; 4. Be taking mugard; 5. Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment; 6. Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine mouthwashes during or within 14 days of starting treatment; 7. Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation; 8. Have used an investigational drug within 28 days of the initiation of study treatment; 9. Have a history of a positive blood test for HIV; 10. At the time of screening, having a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study; 11. Participants with a treatment plan consisting of chemoradiation followed by further chemotherapy; 12. Participants with body weight less than 35 kg, 77 lbs; 13. Women who are pregnant or who are breastfeeding; 14. Participants with known intolerance to platin drugs; 15. History of insulin-dependent Diabetes Mellitus; and 16. Participants with Hepatitis B/C.

Inclusion Criteria

Exclusion Criteria

1. Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN);
2. Be scheduled to receive radiotherapy or proton therapy administered with a curative intent;
3. If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant;
4. If male and of child bearing potential, adequate methods of contraception must be employed including use of condoms with spermicide. No sperm donation for 90 days until after the conclusion of the study;
5. Must be receiving cisplatin for chemotherapy;
6. Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
7. Must have a score 2 or less on the ECOG performance status;
8. Participant life expectancy ≥ 6 months; and
9. Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):

1. Prior radiotherapy of the head and neck;
2. Have a clinically significant infection defined as any acute viral, bacterial or fungal infection, which requires specific therapy. Anti-infectious therapy must have been completed within 14 days of starting study treatment;
3. Be taking any non-approved therapy for oral mucositis, including β-carotene, tocopherol, laser irradiation, brushing the oral mucosa with silver-nitrate prophylactically, systemic TGF-β (transforming growth factor beta), or systemic KGF (keratinocyte growth factor) during or within 14 days of starting treatment;
4. Be taking mugard;
5. Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of starting treatment;
6. Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine mouthwashes during or within 14 days of starting treatment;
7. Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
8. Have used an investigational drug within 28 days of the initiation of study treatment;
9. Have a history of a positive blood test for HIV;
10. At the time of screening, having a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study;
11. Participants with a treatment plan consisting of chemoradiation followed by further chemotherapy;
12. Participants with body weight less than 35 kg, 77 lbs;
13. Women who are pregnant or who are breastfeeding;
14. Participants with known intolerance to platin drugs;
15. History of insulin-dependent Diabetes Mellitus; and
16. Participants with Hepatitis B/C.

Contacts and Locations

Study Contact

Benji Crane

CONTACT

6264376506

bjcrane@matrixbiomed.com

Principal Investigator

Benji Crane

STUDY_DIRECTOR

Matrix Biomed, Inc.

Study Locations (Sites)

UCSD

La Jolla, California, 92093

United States

Mercy Medical Center

Merced, California, 95340

United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158

United States

Central Coast Medical Oncology

Santa Maria, California, 93454

United States

Mission Hope Health Center

Santa Maria, California, 93454

United States

Montefiore Medical Center-Einstein Campus

Bronx, New York, 10461

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Seattle Cancer Care Alliance

Seattle, Washington, 98195

United States

University of Washington Medical Center

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Matrix Biomed, Inc.

Benji Crane, STUDY_DIRECTOR, Matrix Biomed, Inc.

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 Registration Dates

Study Start Date2019-05-13

Study Completion Date2025-12

Study Record Updates

Study Start Date2019-05-13

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

cisplatin toxicity

Additional Relevant MeSH Terms

Mucositis
Nephrotoxicity
Ototoxicity