Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Oral Mucositis

In brief

The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy

Key facts

Study ID

NCT01403064

Run by

CSL Behring

People needed

76

Starts

2011-07-01

Expected to finish

2014-03-01

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have recently diagnosed (< than 6 months prior to screening visit date), pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects with a history of surgical management (approximately 4-6 weeks before RT with sufficient time for post-surgical healing) are eligible
• Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy.
• Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard carboplatin regimen administered weekly (100 mg/m2)
• Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• CRP < 80 mg/L
• Have adequate hematopoietic, hepatic, and renal function at the screening visit

You may not qualify if…

• Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor
• Metastatic disease (M1) Stage IV C
• Any prior history of head and neck cancer
• Prior radiation to the head and neck
• Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; or anticipation of need for a major surgical procedure during the clinical trial
• Active infectious disease, excluding oral candidiasis
• Have OM at the screening visit
• Have a history of hypersensitivity to monoclonal antibody

Where it is running

• Morton Plant Mease Health Care — Clearwater, Florida, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Center — Detroit, Michigan, United States
• Detroit Clinical Research Center — Farmington Hills, Michigan, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Mount Sinai School of Medicine — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Cancer Specialists of Southern Texas — Corpus Christi, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• VA Puget Sound Health Care Syatem — Seattle, Washington, United States
• St. Vincent's Hospital — Darlinghurst, New South Wales, Australia
• Calvary Mater Newcastle — Waratah, New South Wales, Australia
• Royale Brisbane and Women's Hospital — Herston, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Adelaide Radiotherapy Centre — Adelaide, South Australia, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• LKH Graz, HNO Ambulanz — Graz, Austria
• Univ. Klinik fur Innere Medizin III — Salzburg, Austria
• Hanusch Krankenhaus — Vienna, Austria
• Cancer Centre of Southeastern Ontario — Kingston, Ontario, Canada
• Maisonneuve-Rosemont Hospital — Montreal, Quebec, Canada
• CHUQ-L'Hotel-Dieu de Quebec — Québec, Canada

Full record on ClinicalTrials.gov

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