Treatment of Radiation and Cisplatin Induced Toxicities With Tempol

  • STATUS
    Recruiting
  • End date
    Apr 25, 2023
  • participants needed
    120
  • sponsor
    Matrix Biomed, Inc.
Updated on 25 March 2022
cancer
absolute neutrophil count
squamous cell carcinoma
a 10
neutrophil count
squamous cell carcinoma of the head and neck
head and neck cancer
tempol
neck cancer

Summary

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.

Description

One hundred and twenty (120) participants with head and neck cancer are scheduled to undergo combined radio- and chemotherapy (n = 120).

Nearly all (90% to 97%) participants receiving radiotherapy in the head and neck will develop some degree of mucositis. Of these participants treated with radiotherapy with or without chemotherapy, 34% to 43% will present severe mucositis. As a result, the participant's quality of life is affected, hospital admittance rates are higher, the use of total parenteral nutrition is increased and interruption of treatment is more frequent, all of which compromise tumor control. Mucositis causes 9% to 19% of chemotherapy and radiotherapy interruption.

A common chemotherapeutic agent used in head and neck cancer is Cisplatin. Cisplatin (cisdiamminedichloroplatinum (II), CDDP) is an antineoplastic drug used in the treatment of many cancers including testicular cancer, ovarian cancer, bladder cancer, head and neck cancer, esophageal cancer, small and non-small cell lung cancer, breast cancer, cervical cancer, stomach cancer, prostate cancer, brain tumors, neuroblastoma, sarcomas, multiple myeloma, melanoma, mesothelioma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, pancreatic cancer, and thyroid cancer. While toxicities include ototoxicity, gastrotoxicity, myelosuppression, and allergic reactions, the main dose-limiting side effect of cisplatin is nephrotoxicity followed by ototoxicity.

Tempol is a piperidine nitroxide. Nitroxides are a class of stable free radical compounds that protects mammalian cells against numerous toxic agents. Tempol protects normal cells from radiation and cisplatin-induced damage; however, in cancerous or tumor cells, Tempol is reduced to its hydroxylamine form that does not and cannot protect the cells from radiation and cisplatin induced damage. This distinction is of particular importance in the setting of cancer treatment, in which both normal and tumor tissue is exposed to radiation and chemotherapy.

Without using Tempol, both normal cells and cancer cells suffer from toxicity. Tempol is the only known compound to possess this functional duality. This compound has the potential to prevent many of the toxicities associated with cisplatin and radiation treatment including the prevention of mucositis, nephrotoxicity, and ototoxicity.

Details
Condition Mucositis, Nephrotoxicity, Ototoxicity
Treatment Placebo solution, Tempol
Clinical Study IdentifierNCT03480971
SponsorMatrix Biomed, Inc.
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Be ≥18 years of age with medically diagnosed squamous cell cancer of the head and neck (SCCHN)
Be scheduled to receive radiotherapy or proton therapy administered with a curative intent
If female and of child bearing potential, be using an effective birth-control method with a history of reliability for the individual participant
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
Must be receiving cisplatin for chemotherapy
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
Must have a score 2 or less on the ECOG performance status
Participant life expectancy ≥ 6 months; and
Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic)
Haematology
Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per
microliter of blood
Hepatic
Total bilirubin ≤ 2 X (Upper limit normal) ULN Alanine amino transferase (ALT) and
Aspartate aminotransferase (AST) ≤5 x ULN
Renal
Serum creatinine ≤ ULN or, if > ULN calculated creatinine clearance (CrCl) ≥ 60 mL/min
Nutritional and metabolic
Urine Albumin < 3.0 mg/dl

Exclusion Criteria

Prior radiotherapy of the head and neck
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
Be taking any non-approved therapy for oral mucositis, including β-carotene
Be taking mugard
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
Have used an investigational drug within 28 days of the initiation of study treatment
Be taking prostaglandins, pentoxifylline or leucovorin during or within 14 days of
Have a history of a positive blood test for HIV
starting treatment
Be rinsing with allopurinol, hydrogen peroxide, sucralfate, or chlorhexidine
Participants with body weight less than 35 kg, 77 lbs
mouthwashes during or within 14 days of starting treatment
Women who are pregnant or who are breastfeeding
Have had a recent, serious, non-malignant medical complication that, in the opinion of
Participants with known intolerance to platin drugs
the investigator, makes the individual unsuitable for study participation
History of insulin-dependent Diabetes Mellitus; and
Participants with Hepatitis B/C
At the time of screening, having a significant active medical illness which, in the
opinion of the investigator, would preclude completion of the study
Participants with a treatment plan consisting of chemoradiation followed by further
chemotherapy
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