None listed
Conditions
Brief summary
The aim of this study is to investigate the feasibility of personalising chemotherapy treatment using in-vitro (in the laboratory) testing of patient-derived cells to guide the choice of chemotherapy for patients with head and neck carcinoma. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with locally advanced, recurrent, or metastatic head and neck carcinoma, and are thought to have a high probability of treatment failure with standard techniques. Study details All participants will undergo definitive surgery and the biopsy will be transported to anatomical pathology where tissue assessment will be done in great detail, followed by transfer of tissues to either Macquarie university or Garvan Institute where cell lines will be developed, tested for tumor markers, tested for chemotherapeutic drugs including target therapy, and then based on an algorithm derived drug recommendation, the clinician will be informed. The patient will be informed of the results and depending on whether they choose to proceed with treatment, they will be assessed for progression of disease using RECIST 1.1 criteria. It is hoped that this study may demonstrate that testing the sensitivity of patient-derived cancer cells to guide choice of chemotherapy agent prior to their administration will reduce tumour progression and improve survival in patients with head and neck carcinoma.
Interventions
The objective of this study is to assess the feasibility of performing in vitro chemosensitivity testing, relaying the information back to the treating clinician in a timely manner and using the results in real-time to guide systemic therapy for patients with recurrent or metastastatic head and neck carcinoma (RMHNC).
After the patient signs the consent form for tumour tissue banking, a biopsy/ definitive surgery will be done. The tissues obtained will then be used to derive cell lines and diff
The objective of this study is to assess the feasibility of performing in vitro chemosensitivity testing, relaying the information back to the treating clinician in a timely manner and using the results in real-time to guide systemic therapy for patients with recurrent or metastastatic head and neck carcinoma (RMHNC). After the patient signs the consent form for tumour tissue banking, a biopsy/ definitive surgery will be done. The tissues obtained will then be used to derive cell lines and different drugs will be tested on those tissues. The timeline from obtaining tissue to drug response data will be 12 weeks. The treating clinician will be provided a list of the top 3-5 drugs recommended for the patient's cancer. This will be conveyed to the patient and chemotherapy/ target therapy will be administered to patients with their consent. Routine patient record review will be done and clinical/ radiological response observed using RECIST 1.1 criteria will determine whether to continue or withdraw the drug. The following list is of the drugs that will be tested on the patient derived cell lines. These will be ranked from most sensitive to least sensitive and given to the treating clinician to relay to the patient. All of these drugs are used in routine clinical practice and can be found on the eviQ database: Carboplatin Cisplatin Docetaxel Doxorubicin Etoposide 5-Fluorouracil Gemcitabine Methotrexate Paclitaxel Pemetrexed Vinorelbine The following list is of drugs that will be tested as part of an exploratory analysis, but will not be recommended to the patient: Ceralasertib AZD6738 Dactolisib BEZ235 Tramatenib Vistusertib Chloroquine Itraconazole Crizotinib Dasatinib Erlotinib Ruxolitinib Sorafenib Erlotinib Palbociclib
Sponsors
Chris O'Brien Lifehouse
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Age equal to 18 years old - Histological or cytological diagnosis of head and neck carcinoma (HNC) - Locally advanced, recurrent or metastatic disease that is thought to have a high probability of treatment failure with standard techniques a. High risk resectable HNC (primary and / or nodal metastases) with sufficient tissue accessible for culture without compromising pathological analysis of the specimen. b. Unresectable HNC (primary or metastatic) with sufficient tissue accessible for culture via open biopsy or core biopsy. - ECOG performance status less than or equal to 2. - Prior systemic therapy is permitted if given more than 6 months prior to study entry in one of the following situations: • as neoadjuvant therapy; • as part of definitive chemo-radiotherapy for locally advanced disease; or • as a component of adjuvant post-surgical treatment. - Adequate haematological function: • Hb more than or equal to 90 g/L • Platelet count more than or equal to 100 • Neutrophil count more than or equal to 1.5 - Adequate biochemical function • Creatinine less than 1.5 times the upper limit of normal • AST and / or ALT less than 3 times the upper limit of normal (less than 5 times the upper limit of normal if hepatic metastases present) • Bilirubin less than 1.5 times the upper limit of normal (unless known Gilberts disease, in which case less than 3 times the upper limit of normal) - Provision of informed consent. - Female subjects of childbearing potential have a negative pregnancy test at screening and on Day 1 prior to dosing. - Female subjects of childbearing potential who are willing to use a highly effective method of birth control or who are surgically sterile or abstain from heterosexual activity for the course of the study and for 6 months after last dose of systemic anticancer therapy.
Exclusion criteria
- Prior therapy for recurrent and metastatic head and neck squamous cell carcinoma other than as outlined in the inclusion criteria - Inability to attend for follow up - Presence of a significant comorbidity that would preclude the use of chemotherapy - Known active Hepatitis B or C infection or HIV infection
Outcome results
None listed