Study of Safety and Efficacy of OncoVEXGM-CSF With Cisplatin for Treatment of Locally Advanced Head and Neck Cancer
This study has been terminated.
(The changing aetiology of squamous cell carcinoma of the head and neck (SCCHN).)
Information provided by (Responsible Party):
First received: July 12, 2010
Last updated: July 31, 2015
Last verified: July 2015
This study is being conducted to learn about the safety and risks of using OncoVEX^GM-CSF to treat patients with head and neck cancer and to see if OncoVEX^GM-CSF and chemoradiation together can destroy the tumours versus the use of chemoradiation alone. This study may provide information on the usefulness of OncoVEX^GM-CSF combined with chemoradiation as a future treatment for head and neck cancer.
SQUAMOUS CELL CARCINOMA
Head and Neck Cancer
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 3 Randomized Trial of Concurrent Cisplatin & Radiotherapy With Or Without ONCOVEXGM-CSF In Previously Untreated Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck
Primary Outcome Measures:
- To demonstrate a statistically significant increase in 2-year event free survival for patients treated with OncoVEX^GM-CSF as compared to patients treated with chemoradiation alone. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2011 (Final data collection date for primary outcome measure)
Experimental: OncoVEX^GM-CSF & Radiation/cisplatin
OncoVEX^GM-CSF injection added to standard Radiation/cisplatin regimen
Up to 4mL of 10^8 pfu/mL per node and up to 8mL total of OncoVEX^GM-CSF and cisplatin (100 mg/m^2) following radiation and OncoVEX^GM-CSF
Active Comparator: Radiation/cisplatin
70 grays of radiation administered in 35 fractions over 7 weeks and 100mg/m^2 administered intervenously on Days 0, 21, 42
Other Name: generic cisplatin
The objective is to evaluate the efficacy and safety of treatment with chemoradiation (CRT) plus OncoVEXGM-CSF compared to CRT alone in previously untreated patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) (stage T2N2-3M0, T3-4N1-3M0) for which surgical resection is not clinical indicated. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with OncoVEXGM-CSF as compared to CRT alone.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male or female ≥ 18 years
- ECOG Performance Status ≤ 1
- Histological evidence (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- Stage III or IV disease (T2N2-3M0, T3-4N1-3M0)
- No evidence of distant metastases by CT or PET/CT scan
- Life expectancy > 4 months
- Neutrophil count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Creatinine clearance ≥ 60 mL/min
- Female patients of child-bearing potential (i.e. not surgically sterile, or not having spontaneous amenorrhea for at least 12 months) must agree to use an effective form of contraception during the treatment phase of the study.
- Male patients must agree to use a condom with spermicide or their female partner must use an effective method of birth control.
- Provide written informed consent in accordance with all applicable regulations and follow the study procedures. Patients must be capable of understanding the investigational nature, potential risks and benefits of the study.
- Prior treatment for locally advanced SCCHN (NO prior surgery for SCCHN except nodal sampling or biopsy for study disease).
- Patients with T1-2N1 or T1N2-3.
- Pre-existing peripheral neuropathy ≥ Grade 2 (motor or sensory).
- Weight loss > 20% of body weight within 3 months of screening (unless purposeful).
- Surgery ≤ 28 days before randomization with the exception of feeding tube placement, dental extractions, central venous catheter placement, biopsies and nodal sampling.
- Cancer of the nasopharynx, sinus, salivary gland or skin.
- Previous radical RT to the head and neck region, excluding superficial RT for a non-melanomatous skin cancer.
- Prior cancers, except: those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix.
- Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as HIV infection, cardiac failure, pulmonary compromise (chronic obstructive pulmonary disease, pneumonia or respiratory decompensation) resulting in hospitalization within 12 months of screening, or active infection.
- Any significant cardiac disease (e.g., New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias..
- High risk for poor compliance with therapy or follow up as assessed by the investigator.
- Active herpes labialis, other lesions due to HSV1 or dermatoses involving or within 50 cm of the lesions to be injected; active HSV1 lesions must have resolved before OncoVEXGM-CSF is injected.
- Prior systemic chemotherapy for any type of cancer.
- Patients for whom radiation therapy is contraindicated.
- Pregnant or breast-feeding female. Confirmation that women of child-bearing potential are not pregnant. A negative serum β- human chorionic gonadotropin (β-hCG) pregnancy test result must be obtained during the screening period.
- Currently enrolled and receiving an investigational agent in a clinical research study or received an investigational agent for any reason within 4 weeks prior to screening.
- Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161498
|Investigative Clinical Research of Indiana
|Indianapolis, Indiana, United States, 46260 |
|James Graham Brown Cancer Center, University of Louisville
|Louisville, Kentucky, United States, 40202 |
|Gabrail Cancer Center
|Canton, Ohio, United States, 44718 |
|Medical Univesity of South Carolina
|Charleston, South Carolina, United States, 29425 |
|VCU Massey Cancer Center
|Richmond, Virginia, United States, 23298 |
|The Royal Marsden Hospital
|London, United Kingdom, SE1 7EH |
||Kevin Harrington, MD
||Royal Marsden, UK
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 12, 2010
||July 31, 2015
||United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by BioVex Limited:
head and neck cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 13, 2015
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell