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Clinical Trials/EUCTR2013-003133-14-PT
EUCTR2013-003133-14-PT
Active, not recruiting
Phase 1

An open-label study to investigate the tolerability, pharmacokinetics and anti-tumor effect following photodynamic therapy (PDT) with single-ascending doses of LUZ11 in patients with advanced head and neck cancer. - Not applicable

uzitin, S.A.0 sites6 target enrollmentSeptember 27, 2013
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
uzitin, S.A.
Enrollment
6
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 27, 2013
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
uzitin, S.A.

Eligibility Criteria

Inclusion Criteria

  • •1\. Able and willing to give written informed consent and adhere to all requirements of the study.
  • •2\. Man or non\-pregnant and non\-breast feeding woman.
  • •3\. Age \= 18 years.
  • •4\. Karnofsky performance status of 60% (60% \= requiring some help, can take care of most personal requirements) or greater.
  • •5\. With histologically confirmed diagnosis of recurrent/refractory squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified (NOS), etc.) of the head/neck.
  • •6\. Clearly visible tumour on the oral cavity or cutaneous surface and that is locally accessible for surface irradiation using a microlens optic fibre.
  • •7\. Head and neck squamous cell carcinoma (HNSCC) progressing after first line of palliative chemotherapy OR progressing \= 6 months after radical chemoradiotherapy OR considered not suitable for standard anti\-neoplastic treatment by a multidisciplinary team.
  • •8\. Absolute granulocyte count \>1,500 cells/mL.
  • •9\. Platelet count \>100,000 cells/mL.
  • •10\. Haemoglobin \>9\.0 g/dL (the use of transfusion or other intervention to achieve Hgb \>9\.0 g/dL is acceptable).

Exclusion Criteria

  • •1\. Life expectancy less than 6 months.
  • •2\. Known hypersensitivity to porphyrins or any of the formulation ingredients.
  • •3\. History of severe hypersensitivity reactions to any drugs.
  • •4\. Porphyria or other diseases exacerbated by light.
  • •5\. Metastatic or locoregional progressive disease not amenable for complete treatment by PDT.
  • •6\. Tumours known to be eroding into a major blood vessel in or adjacent to the irradiation site.
  • •7\. Planned skin phototherapy session within the study timeframe.
  • •8\. Planned surgical procedure within the study timeframe.
  • •9\. Coexisting ophthalmic disease likely to require slit\-lamp examination within the study timeframe.
  • •10\. Existing therapy with a photosensitising agent.

Outcomes

Primary Outcomes

Not specified

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