Status:
TERMINATED
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
Lead Sponsor:
CSL Behring
Conditions:
Oral Mucositis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 radiot...
Detailed Description
This was a Phase 2, placebo-controlled, double-blind study in subjects newly diagnosed with head and neck cancer (who had not received previous treatment for oral mucositis) and who were receiving con...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01403064
Start Date
July 1 2011
End Date
March 1 2014
Last Update
May 11 2021
Active Locations (31)
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1
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
4
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48336