Clinical trial NCT02975739: Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors
Official title: Feasibility of Holmium-166 Microspheres for Selective Intra-tumoural Treatment in Head and Neck Cancer: Biodistribution and Safety in Patients With Malignancy of the Tongue
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Radioisotopes
Head and Neck Neoplasms
Keywords: Intratumoral
Tongue
Microspheres
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective is to establish the feasibility of 166-Holmium microspheres for intratumoral injections in oral squamous cell carcinoma (OSCC) of the tongue.

Participants will receive intratumoral injections with a low radioactive 166-Holmium microspheres followed by surgical resection

Detailed description: 166-Holmium microspheres poly lactic acid microspheres are currently used in selective internal radiation therapy. These microspheres emits beta radiation. The majority of the radiation dose will be absorbed within 3.2 mm with a maximum penetration in tissue of 9 mm. Therefore this can result in a high local tumor ablative dose with minimal dose to healthy adjacent tissue.

Eligibility criteria: Inclusion Criteria:

1. Patients must have given written informed consent.
2. Aged 18 years and over.
3. Confirmed histological diagnosis of squamous cell carcinoma of the tongue.
4. primary tumor, regional nodes, metastasis (TNM) stage T1-2 Nx M0.
5. Eligible for local surgery with curative intent.
6. World Health Organization (WHO) Performance status 0-2.

Exclusion Criteria:

1. Previous oncologic surgery and/or external beam radiation therapy on the tongue and oral floor.
2. Major surgery (Oro-facial) within the past 4 weeks or incompletely healed surgical incisions before starting study therapy.
3. Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.03) grade 2 from previous anti-cancer therapy.
4. Pregnancy or nursing (women of child-bearing potential).
5. Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression.
6. Previous enrolment in the present study.

Primary outcomes:
measure: Total amount of activity leakage (in percentage) in the oral cavity rinsing fluid.
timeFrame: upto 5 minutes after administration
Secondary outcomes:
measure: Occurrence of (serious) adverse events
timeFrame: Between administration and resection of the tumor (max 12 days)
measure: The biodistribution of Holmium-166 microspheres after intra-tumoural injection
timeFrame: upto 30 minutes after administration
measure: The biodistribution of Holmium-166 microspheres after intra-tumoural injection
timeFrame: 1-2 hours after administration
measure: The biodistribution of Holmium-166 microspheres after intra-tumoural injection
timeFrame: 3 hours after administration
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Marnix G Lam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Es RJ, Nijsen JF, van het Schip AD, Dullens HF, Slootweg PJ, Koole R. Intra-arterial embolization of head-and-neck cancer with radioactive holmium-166 poly(L-lactic acid) microspheres: an experimental study in rabbits. Int J Oral Maxillofac Surg. 2001 Oct;30(5):407-13. doi: 10.1054/ijom.2001.0129.
citation: Bult W, Vente MA, Vandermeulen E, Gielen I, Seevinck PR, Saunders J, van Het Schip AD, Bakker CJ, Krijger GC, Peremans K, Nijsen JF. Microbrachytherapy using holmium-166 acetylacetonate microspheres: a pilot study in a spontaneous cancer animal model. Brachytherapy. 2013 Mar-Apr;12(2):171-7. doi: 10.1016/j.brachy.2012.08.001. Epub 2012 Sep 19.
citation: Smits ML, Nijsen JF, van den Bosch MA, Lam MG, Vente MA, Mali WP, van Het Schip AD, Zonnenberg BA. Holmium-166 radioembolisation in patients with unresectable, chemorefractory liver metastases (HEPAR trial): a phase 1, dose-escalation study. Lancet Oncol. 2012 Oct;13(10):1025-34. doi: 10.1016/S1470-2045(12)70334-0. Epub 2012 Aug 22.
citation: Bult W, de Leeuw H, Steinebach OM, van der Bom MJ, Wolterbeek HT, Heeren RM, Bakker CJ, van Het Schip AD, Hennink WE, Nijsen JF. Radioactive holmium acetylacetonate microspheres for interstitial microbrachytherapy: an in vitro and in vivo stability study. Pharm Res. 2012 Mar;29(3):827-36. doi: 10.1007/s11095-011-0610-7. Epub 2011 Nov 9.