Using penicillamine to enhance radiation treatment for recurrent head and neck cancer
Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer: a Single-center, Single-arm, Phase II Clinical Trial
This study is testing if adding penicillamine to radiation treatment can help people with recurrent head and neck cancer respond better to the therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06103617 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of penicillamine, a copper chelator, as a radiosensitizer for patients with recurrent head and neck cancer. The study is based on preclinical findings that suggest copper accumulation contributes to radioresistance, and reducing copper levels may improve treatment outcomes. Participants will receive penicillamine alongside standard radiotherapy to assess its impact on tumor response and recurrence rates. The trial will include patients aged 18-75 who have previously undergone radiotherapy or chemoradiotherapy for head and neck tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with recurrent head and neck tumors who have previously received standard radiotherapy.
Not a fit: Patients who are pregnant, unable to take oral medication, or have known allergies to penicillamine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and survival rates for patients with recurrent head and neck cancer.
How similar studies have performed: While the use of copper chelators in radiosensitization is a novel approach, preclinical studies have shown promising results, indicating potential for success in this clinical setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Southern medical university — Guangzhou, Guangdong, China (Recruiting)
- Nanfang Hospital, Sourthern Medical University — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Jian Guan, M.D — Nanfang Hospital, Southern Medical University
- Study coordinator: Jian Guan, M.D
- Email: 51643930@qq.com
- Phone: +86-1363210224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.