Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2025-06-01

Brief Summary

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Our preclinical study confirmed that copper accumulation can lead to radioresistance in vitro and in vivo, and reducing the concentration of copper with copper chelator help to overcome radioresistance. Therefore, the investigators plan to carry out a prospective interventional phase II clinical trial to explore the safety and efficacy of penicillamine (a common copper chelator) as a radiosensitizer in the treatment of recurrent head and neck cancer.

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Detailed Description

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Head and neck cancer is the sixth most common cancer worldwide. Radiotherapy is an important measure to control tumor recurrence. Although radiotherapy has been widely used in patients with head and neck cancer, the 2-year local recurrence rate of patients with locally advanced disease is still as high as 50%-60%. This is associated with a lower radiosensitivity in head and neck cancer. High doses of reirradiation (\>60 Gy) are associated with severe late complications and treatment-related mortality. Therefore, finding an appropriate sensitizer to improve the radiosensitivity is the key to improve the survival of recurrent patients. Our preclinical study confirmed that copper accumulation can lead to radioresistance in vitro and in vivo, and the results were published in J Hepatol (IF=25.7). Penicillamine is a commonly used copper chelator in clinical practice and can reduce the concentration of copper in the body. Based on this, the investigators plan to carry out a prospective interventional phase II clinical trial to explore the safety and efficacy of penicillamine as a radiosensitizer in the treatment of recurrent head and neck cancer.

Conditions

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Head and Neck Cancer Recurrent Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Penicillamine group

Participants in this group are treated with Penicillamine (250mg each time, 4 times per day) during reradiation.

Group Type EXPERIMENTAL

Penicillamine

Intervention Type DRUG

Participants in this group are treated with Penicillamine (250mg each time, 4 times per day) during reradiation.

Interventions

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Penicillamine

Participants in this group are treated with Penicillamine (250mg each time, 4 times per day) during reradiation.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Sign informed consent
2. The age is 18-75 years
3. Previously received standard radical radiotherapy or chemoradiotherapy
4. Head and neck tumors with in situ or cervical lymph node recurrence confirmed by pathological biopsy and imaging examination
5. ECOG PS：0/1
6. Laboratory examination confirmed good organ function, which should be carried out within 10 days before the first treatment.

Exclusion Criteria

1. After evaluation, it does not meet the indications of re-radiotherapy
2. Unable to take oral medication
3. Pregnancy or lactation
4. Known allergy to penicillamine
5. Patients who are judged by the researcher as unsuitable to participate in this trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No