Study of Safety and Efficacy of OncoVEXGM-CSF With Cisplatin for Treatment of Locally Advanced Head and Neck Cancer

This study has been terminated.
Sponsor:
Information provided by:
BioVex Limited
ClinicalTrials.gov Identifier:
NCT01161498
First received: July 12, 2010
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
SQUAMOUS CELL CARCINOMA
Head and Neck Cancer
Biological: OncoVEX^GM-CSF
Other: Radiation/cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BioVex Limited:

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 ]

Estimated Enrollment: 528
Study Start Date: December 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OncoVEX^GM-CSF & Radiation/cisplatin
OncoVEX^GM-CSF injection added to standard Radiation/cisplatin regimen
Biological: OncoVEX^GM-CSF
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 Other: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥ 18 years
  2. ECOG Performance Status ≤ 1
  3. Histological evidence (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  4. Stage III or IV disease (T2N2-3M0, T3-4N1-3M0)
  5. No evidence of distant metastases by CT or PET/CT scan
  6. Life expectancy > 4 months
  7. Neutrophil count ≥ 2,000/mm^3
  8. Platelet count ≥ 100,000/mm^3
  9. Hemoglobin ≥ 10 g/dL
  10. Bilirubin ≤ 1.5 times ULN
  11. AST and ALT ≤ 2.5 times ULN
  12. Alkaline phosphatase ≤ 2.5 times ULN
  13. Creatinine clearance ≥ 60 mL/min
  14. 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.
  15. Male patients must agree to use a condom with spermicide or their female partner must use an effective method of birth control.
  16. 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.

Exclusion Criteria:

  1. Prior treatment for locally advanced SCCHN (NO prior surgery for SCCHN except nodal sampling or biopsy for study disease).
  2. Patients with T1-2N1 or T1N2-3.
  3. Pre-existing peripheral neuropathy ≥ Grade 2 (motor or sensory).
  4. Weight loss > 20% of body weight within 3 months of screening (unless purposeful).
  5. Surgery ≤ 28 days before randomization with the exception of feeding tube placement, dental extractions, central venous catheter placement, biopsies and nodal sampling.
  6. Cancer of the nasopharynx, sinus, salivary gland or skin.
  7. Previous radical RT to the head and neck region, excluding superficial RT for a non-melanomatous skin cancer.
  8. 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.
  9. 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.
  10. 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..
  11. High risk for poor compliance with therapy or follow up as assessed by the investigator.
  12. 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.
  13. Prior systemic chemotherapy for any type of cancer.
  14. Patients for whom radiation therapy is contraindicated.
  15. 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.
  16. 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.
  17. Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use.
  Contacts and Locations
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

Locations
United States, Indiana
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States, 46260
United States, Kentucky
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, United States, 40202
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, South Carolina
Medical Univesity of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
VCU Massey Cancer Center
Richmond, Virginia, United States, 23298
United Kingdom
The Royal Marsden Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
BioVex Limited
Investigators
Principal Investigator: Kevin Harrington, MD Royal Marsden, UK
  More Information

No publications provided

Responsible Party: Rob Coffin, BioVex, Inc.
ClinicalTrials.gov Identifier: NCT01161498     History of Changes
Other Study ID Numbers: 006/09
Study First Received: July 12, 2010
Last Updated: August 2, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by BioVex Limited:
head and neck cancer
squamous cell
OncoVEXGM-CSF
Oncovex
chemoradiation
Cisplatin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 27, 2014