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Trial Title:
Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers
NCT ID:
NCT05835804
Condition:
Squamous Cell Carcinoma of the Head and Neck
Paclitaxel
Carboplatin
Nivolumab
Conditions: Official terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Recurrence
Conditions: Keywords:
Squamous Cell Carcinoma of the Head and Neck
local reccurence of malignant tumor
intrumoral chemotherapy
gemcitabin
paclitaxel
carboplatin
nivolumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GCP intratumoral catheter
Description:
After local anaesthesia, intratumoral catheter will be place (one or several depending
tumour criteria).The catheter placement could be guided by radiological imaging.
Gemcitabine (200mg/l), carboplatin (100mg/l) and paclitaxel (20mg/l) will be each diluted
in each in 160ml of NaCl0.9%. GCP will be administered successively for 8hours, at 20ml/h
with a total duration of 24hours. The ITC will be done every 28 days for 6 times maximum
in case of good response and tolerance. Nivolumab 240 mg IV will be started 1 to 7 days
before the first intratumoral infusion and every 15 days, until progression or 2 until
years in case of partial response, complete response or stabilization. Evaluation of
tumour size will be done by CT-scan, or MRI 2every 2 months and PET-FDG every 3 months.
Arm group label:
Intratumoral chemotherapy
Summary:
Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN)
after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic
options.
Intratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the
local cisplatin retention lead to a 50 % response rate in several studies but was given
up due to the poor local tolerance with frequent necrosis of the peritumoral tissues.
Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These
chemotherapies seem to be interesting options for intratumoral infusion: their different
effect could lead to avoid chemotherapy resistance with a good tolerance profile, without
tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by
Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of
this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The
presence of tumoral antigen could lead to better response to immunotherapy; association
of chemotherapy and immunotherapy seems a promosing association to avoid treatment
resistance as cytotoxic release tumoral antigen; it could also be associated to an
abscopal effect.
The aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent
SCCHN treated by nivolumab.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- WHO status : 0, 1 or 2.
- Age > 18ans
- Locally recurrence of a histologically-proven SCCHN after failure of conventional
treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
- Nivolumab treatment in second line encouring according to AMM but with insufficient
efficacy
- Possible location of the tumour by clinical examination, CT-scan
- Metastases are admitted if there is no vital prognoses threaten and if a clinical
benefit is expected by treating local recurrence.
- Neutrophils > 1000/mm3.
- Platelets > 100 000/mm3.
- Blood créatinine < 15 mg/L. Blood bilirubine < 30 mg/L
- Prothrombin rate > 70 %.
- Social insurance
- Informed consent
Exclusion Criteria:
- WHO status : 0, 1 or 2.
- Age > 18ans
- Locally recurrence of a histologically-proven SCCHN after failure of conventional
treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
- Nivolumab treatment in second line encouring according to AMM but with insufficient
efficacy
- Possible location of the tumour by clinical examination, CT-scan
- Metastases are admitted if there is no vital prognoses threaten and if a clinical
benefit is expected by treating local recurrence.
- Neutrophils > 1000/mm3.
- Platelets > 100 000/mm3.
- Blood créatinine < 15 mg/L. Blood bilirubine < 30 mg/L
- Prothrombin rate > 70 %.
- Social insurance
- Informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Amiens Picardie
Address:
City:
Amiens
Zip:
80054
Country:
France
Contact:
Last name:
Aline HOUESSINON, MD
Phone:
03 22 45 54 99
Email:
houessinon.aline@chu-amiens.fr
Investigator:
Last name:
Bruno CHAUFFERT, Pr
Email:
Sub-Investigator
Investigator:
Last name:
Aurelie MOREIRA, MD
Email:
Sub-Investigator
Investigator:
Last name:
Stéphanie DAKPE, Pr
Email:
Sub-Investigator
Investigator:
Last name:
Jérémie BETTONI, MD
Email:
Sub-Investigator
Investigator:
Last name:
Bernard DEVAUCHELLE, Pr
Email:
Sub-Investigator
Investigator:
Last name:
Sylvie TESTELIN, Pr
Email:
Sub-Investigator
Investigator:
Last name:
Aurelie BIET, MD
Email:
Sub-Investigator
Investigator:
Last name:
Cyril PAGE, Pr
Email:
Sub-Investigator
Investigator:
Last name:
Alexandre COUTTE, MD
Email:
Sub-Investigator
Investigator:
Last name:
Antoine GALMICHE, PR
Email:
Sub-Investigator
Investigator:
Last name:
Michel LEFRANC, Pr
Email:
Sub-Investigator
Investigator:
Last name:
Jean Marc CONSTANS, Pr
Email:
Sub-Investigator
Start date:
November 1, 2024
Completion date:
April 2026
Lead sponsor:
Agency:
Centre Hospitalier Universitaire, Amiens
Agency class:
Other
Source:
Centre Hospitalier Universitaire, Amiens
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05835804
