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

Primary Purpose

Oral Mucositis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALD518
0.9% saline
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Mucositis focused on measuring Oral mucositis; head and neck cancer; chemotherapy; radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Morton Plant Mease Health Care
  • Dana Farber Cancer Institute
  • Karmanos Cancer Center
  • Detroit Clinical Research Center
  • John Theurer Cancer Center at Hackensack University Medical Center
  • University of New Mexico Cancer Center
  • Mount Sinai School of Medicine
  • SUNY Upstate Medical University
  • Temple University Hospital
  • Spartanburg Regional Medical Center
  • Cancer Specialists of Southern Texas
  • University of Texas Southwestern Medical Center
  • VA Puget Sound Health Care Syatem
  • St. Vincent's Hospital
  • Calvary Mater Newcastle
  • Royale Brisbane and Women's Hospital
  • Princess Alexandra Hospital
  • Adelaide Radiotherapy Centre
  • Royal Adelaide Hospital
  • LKH Graz, HNO Ambulanz
  • Univ. Klinik fur Innere Medizin III
  • Hanusch Krankenhaus
  • Cancer Centre of Southeastern Ontario
  • Maisonneuve-Rosemont Hospital
  • CHUQ-L'Hotel-Dieu de Quebec
  • Universitatsklinikum Freiburg
  • University Medical School, Saarland
  • Uniklinik Koln
  • A.O. San Paolo - Polo Universitario
  • Istituto Nazionale dei tumari
  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Open Label ALD518

ALD518 Dose 1

ALD518 Dose 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy
Gray (Gy) is used as a unit of the radiation quantity absorbed dose that measures the energy deposited by ionizing radiation in a unit mass of matter being irradiated, and is used for measuring the delivered dose of ionizing radiation in applications such as radiotherapy. The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy
Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy
The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy

Secondary Outcome Measures

Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Duration of Ulcerative and Severe OM
Time to Onset of Ulcerative and Severe OM
ALD518 Plasma Concentration at Varying Weeks
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
Scored on a scale from 0 (worst possible overall health) to 10 (perfect overall health). Higher scores represent better overall health.
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
The FACT-HN consists of 28 general + 11 head and neck specific items, each rated on a 0 (not at all) to 4 (very much) Likert type scale. The total score ranges from 0 to 148. Higher scores represent better quality of life.
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale from 0 (not at all fatigued) to 4 (very much fatigued). The total score ranges from 0 to 52. Higher scores represent less fatigue.
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
The level of C-reactive protein (CRP), which can be measured in your blood, increases when there's inflammation in your body.

Full Information

First Posted
July 25, 2011
Last Updated
April 16, 2021
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT01403064
Brief Title
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
Official Title
A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALD518 in the Reduction of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concomitant Chemotherapy and Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
due to lack of efficacy
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 radiotherapy
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 concomitant chemotherapy and radiotherapy. Subject eligibility, including tumor staging, was assessed during the screening period, which was to occur within 30 days prior to the initiation of radiation therapy. The radiation therapy treatment period was approximately 7 weeks, depending on the subject's prescribed radiation plan. Prior to the randomized portion of the trial, the first 7 subjects enrolled in the study entered a safety run-in evaluation and received a total of 2 doses of open-label clazakizumab 160 mg IV, 4 weeks apart (Day 0 and Week 4 of radiation); these subjects were not eligible for the randomized portion of the study. Subsequent to completion of the safety run-in, eligible subjects were randomized 1:1:1 to treatment with 2 doses of clazakizumab 160 mg, or clazakizumab 320 mg, or placebo, administered IV 3 weeks apart (Day 0 and Week 3 of radiation therapy). All subjects were to be followed for 4 weeks post last day of radiotherapy treatment for the primary efficacy and safety assessments and then for up to an additional 12 months of long-term follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Oral mucositis; head and neck cancer; chemotherapy; radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label ALD518
Arm Type
Experimental
Arm Title
ALD518 Dose 1
Arm Type
Experimental
Arm Title
ALD518 Dose 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
ALD518
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
IV Infusion
Primary Outcome Measure Information:
Title
Percent of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Time Frame
Up to 15 months
Title
Number of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Abnormalities
Time Frame
Up to 15 months
Title
Percent of Participants With All Grades of Oral Mucositis (OM) at a Radiation Dose of 55 Gy
Description
Gray (Gy) is used as a unit of the radiation quantity absorbed dose that measures the energy deposited by ionizing radiation in a unit mass of matter being irradiated, and is used for measuring the delivered dose of ionizing radiation in applications such as radiotherapy. The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy
Time Frame
Up to 12 weeks
Title
Number of Participants With All Grades of OM at a Radiation Dose of 55 Gy
Description
The 55 Gy ulcerative OM assessment is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in their cumulative dose of radiation being ≥ 55 Gy
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percent of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
Description
The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Time Frame
Up to 12 weeks
Title
Number of Participants With Ulcerative OM at Varying Cumulative Radiation Doses (Gy)
Description
The ulcerative OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first ulcerative OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Time Frame
Up to 12 weeks
Title
Percent of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
Description
The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Time Frame
Measured from onset of OM through Week 12
Title
Number of Participants With Severe OM at Varying Cumulative Radiation Doses (Gy)
Description
The severe OM assessment at a specific cumulative radiation dose (35 Gy, 45 Gy, 55 Gy or 65 Gy) is defined as the first severe OM assessment that occurred on the day of or after the subject received the radiation therapy that first resulted in the specific cumulative dose of radiation being ≥35 Gy, ≥45 Gy, ≥55 Gy or≥ 65 Gy
Time Frame
Up to 12 weeks
Title
Duration of Ulcerative and Severe OM
Time Frame
Up to 12 weeks
Title
Time to Onset of Ulcerative and Severe OM
Time Frame
Up to 12 weeks
Title
ALD518 Plasma Concentration at Varying Weeks
Time Frame
Baseline and up to 12 weeks
Title
Oral Mucositis Daily Questionnaire (OMDQ) Overall Health Score at Varying Cumulative Radiation Doses (Gy)
Description
Scored on a scale from 0 (worst possible overall health) to 10 (perfect overall health). Higher scores represent better overall health.
Time Frame
Baseline and up to 12 weeks
Title
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) Questionnaire Overall Assessment Score at Varying Cumulative Radiation Doses (Gy)
Description
The FACT-HN consists of 28 general + 11 head and neck specific items, each rated on a 0 (not at all) to 4 (very much) Likert type scale. The total score ranges from 0 to 148. Higher scores represent better quality of life.
Time Frame
Baseline and up to 12 weeks
Title
Functional Assessment of Chronic Illness Therapy - Fatigue Questionnaire (FACIT-F) Score at Varying Cumulative Radiation Doses (Gy)
Description
The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale from 0 (not at all fatigued) to 4 (very much fatigued). The total score ranges from 0 to 52. Higher scores represent less fatigue.
Time Frame
Baseline and up to 12 weeks
Title
Mean Change From Baseline in C-reactive Protein (CRP) Values at Varying Weeks
Description
The level of C-reactive protein (CRP), which can be measured in your blood, increases when there's inflammation in your body.
Time Frame
Baseline and up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Smith, MD FRCP
Organizational Affiliation
Alder Biopharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Morton Plant Mease Health Care
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Detroit Clinical Research Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Cancer Specialists of Southern Texas
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
VA Puget Sound Health Care Syatem
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Royale Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Adelaide Radiotherapy Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
LKH Graz, HNO Ambulanz
City
Graz
Country
Austria
Facility Name
Univ. Klinik fur Innere Medizin III
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Hanusch Krankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Cancer Centre of Southeastern Ontario
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHUQ-L'Hotel-Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
University Medical School, Saarland
City
Homburg
ZIP/Postal Code
66424
Country
Germany
Facility Name
Uniklinik Koln
City
Koln
ZIP/Postal Code
50924
Country
Germany
Facility Name
A.O. San Paolo - Polo Universitario
City
Milan
ZIP/Postal Code
20142
Country
Italy
Facility Name
Istituto Nazionale dei tumari
City
Milan
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy

12. IPD Sharing Statement

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

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