NCT01606566

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Amphinex induced PCI of bleomycin ('PC-A11') with superficial and/or interstitial laser light application in patients with recurrent SCCHN.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2012

Typical duration for phase_2

Geographic Reach
6 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

May 21, 2012

Last Update Submit

February 16, 2022

Conditions

Recurrent Head and Neck CancerCarcinoma, Squamous Cell of Head and Neck

Keywords

RecurrentHead and NeckNeoplasmsSquamous Cell CarcinomaAmphinexCancerPhotodynamic therapyChemotherapyBleomycin

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicities (DLT)

    The 'run-in part' primary endpoint

    3 months

  • The proportion of patients with non-progressive local disease at 6 months

    The expansion part primary endpoint

    6 months

Secondary Outcomes (5)

  • Pharmacokinetics of 'PC-A11' in plasma

    3 months

  • The proportion of patients with non-progressive local disease at 3 months

    12 months

  • Proportion of patients with adverse events

    12 months

  • Progression free survival

    12 months

  • QoL using EORTC Quality of Life Questionnaire (QLQ)-C30 version 3.0 and QLQ-H&N35

    12 months

Other Outcomes (5)

  • Evaluation of biomarkers obtained from tumour tissue and blood samples

    12 months

  • Evaluation of skin photosensitivity

    3 months

  • Evaluation of local tumour responses by volumetric measurements.

    12 months

  • +2 more other outcomes

Study Arms (1)

Amphinex induced PCI of bleomycin

EXPERIMENTAL

Drug: Amphinex induced PCI of bleomycin Intervention:Intravenous administration of Amphinex (day 0) followed by intravenous administration of bleomycin and laser light application (day 4). Laser light application could be both interstitial and/or superficial depending on the tumour location.

Drug: Amphinex induced PCI of bleomycin

Interventions

Amphinex induced PCI of bleomycinDRUG

Intravenous administration of 0.25 mg/kg Amphinex (day 0) followed by intravenous administration of bleomycin (15000 IU/m2, day 4) and laser light application (3 hours (+/- 1 hour) after bleomycin administration).

Also known as: Blenoxane
Amphinex induced PCI of bleomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study eligibility reviewed and approved by interdisciplinary hospital team.
  • Age minimum 18 years.
  • Histologically or cytological confirmed diagnosis of recurrent or metastatic SCCHN considered unsuitable for surgery and radiotherapy (patients with distant or regional metastatic disease may be eligible if local palliation is needed)
  • Performance status (WHO scale/ECOG) ≤ 1.
  • At least one measurable target lesion at baseline.
  • Local disease including margin (0.5 cm) treatable with superficial and/or interstitial laser light application (for superficial lesions: entire tumour assessable for laser light application/interstitial treatment: insertion of implants feasible)
  • Estimated life expectancy of at least 12 weeks.
  • Written informed consent.

You may not qualify if:

  • Prior Treatment:
  • Local treatment of their SCCHN by surgery within the previous 4 weeks or by radiation within the previous 3 months.
  • Previous treatment with systemic chemotherapy for their SCCHN within the last 4 weeks
  • Previous treatment with Photodynamic Therapy within the last 6 months.
  • Prior treatment with bleomycin.
  • Prior treatment with PC-A11.
  • Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) which did not resolve to ≤ grade 2.
  • Current Treatment:
  • Current or recent (within 30 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
  • Other concurrent anticancer therapies.
  • Treatment with a medicinal product with known or potential drug-drug interaction with bleomycin or Amphinex.
  • Haematology, coagulation and biochemistry:
  • Inadequate bone marrow function:
  • Absolute Neutrophil Count (ANC): \< 1.5 x 109/L, or platelet count \<100 x 109/L or haemoglobin \< 6 mmol/L.
  • Inadequate liver function, defined as:
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU de Nantes Hôtel Dieu

Nantes, Nantes Cedex 1, 44093, France

Location

Centre Alexis Vautrin (CAV)-Nancy Université

Nancy, France

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Charité Comprehensive Cancer Center

Berlin, 10117, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Ludwig Maximilian University Munich

München, Germany

Location

Institute of Oncology, Vilnius University

Vilnius, 08660, Lithuania

Location

The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

Location

Szpital Specjalistyczny w Brzozowie

Brzozów, Poland

Location

University College London Hospital

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckRecurrenceNeoplasmsCarcinoma, Squamous Cell

Interventions

Bleomycin

Condition Hierarchy (Ancestors)

Neoplasms by SiteCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Baris Karakullukcu, MD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 25, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2015

Study Completion

January 1, 2016

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

PL(1)DE(4)NL(1)GB(1)LI(1)FR(2)