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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

July 12, 2010
August 2, 2011
December 2010
October 2014   (final data collection date for primary outcome measure)
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 ]
To demonstrate a statistically significant increase in 2-year event free survival for patients treated with OncoVEXGM-CSF as compared to patients treated with chemoradiation alone. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01161498 on ClinicalTrials.gov Archive Site
Not Provided
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Study of Safety and Efficacy of OncoVEXGM-CSF With Cisplatin for Treatment of Locally Advanced Head and Neck Cancer
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • SQUAMOUS CELL CARCINOMA
  • Head and Neck Cancer
  • 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
  • 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
  • Experimental: OncoVEX^GM-CSF & Radiation/cisplatin
    OncoVEX^GM-CSF injection added to standard Radiation/cisplatin regimen
    Intervention: Biological: OncoVEX^GM-CSF
  • Active Comparator: Radiation/cisplatin
    Intervention: Other: Radiation/cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
528
December 2017
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01161498
006/09
Yes
Rob Coffin, BioVex, Inc.
BioVex Limited
Not Provided
Principal Investigator: Kevin Harrington, MD Royal Marsden, UK
BioVex Limited
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP