Oral MucositisPhase 2NCT01247246
Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer
A Phase 2 study testing SCV-07 in people with Oral Mucositis, run by SciClone Pharmaceuticals at 49 sites in United States.
Trial summary
This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- SCV-07
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 49 sitesUnited States
- Study dates
- Dec 2010to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to understand and sign an informed consent form (ICF) for the study approved by the Investigator's local or a central Institutional Review Board (IRB)
- Have recently diagnosed, pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx, or larynx that will be treated with ChemoRT as first-line treatment; subjects with a history of surgical management 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 50 and 72 Gy. Planned radiation treatment fields must include at least 2 oral sites (buccal mucosa, floor of oral cavity, tongue, or soft palate), with each site receiving ≥ 50 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)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Have adequate hematopoietic, hepatic, and renal function at the screening visit:
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- Hematopoietic function
- Hemoglobin ≥ 10 g/dL
- Absolute neutrophil counts (ANC) ≥ 1,500 cells/mm3
- Platelet count ≥ 100 × 109/L
- Hepatic function
- Total bilirubin < 1.5 times the upper-normal limit (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN
- Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site's local laboratory. To be eligible for the study, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min
- Have a negative serum pregnancy test if a woman is of childbearing potential
- Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential
- Males or females aged 18 years or older.
Who cannot join
- Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
- Metastatic disease (M1) Stage IV C
- Prior radiation to the head and neck
- Plan to be treated with cetuximab (Erbitux®)
- Have undergone induction CT
- History of other malignant tumors, excluding non-melanoma skin cancer or curatively excised in situ cervical carcinoma
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- Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for a major surgical procedure during the study
- Active infectious disease, excluding oral candidiasis
- Have OM at the baseline visit
- Have a diagnosis of autoimmune disease requiring chronic immunosuppression
- Known seropositivity for HIV, HBV, or HCV
- Prior use of SCV 07
- Have used any investigational agent within 30 days of randomization
- Are pregnant or breastfeeding
- Known allergies or intolerance to cisplatin
- Unable to give informed consent or comply with study requirements, including completing the subject diary and QOL instruments
- Have any other condition or therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with follow-up visits.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Summa Health System
Akron, Ohio, 44304
St. John's Cancer Center
Anderson, Indiana, 46016
Comprehensive Blood and Cancer Center
Bakersfield, California, 99309
University of Maryland Medical Center
Baltimore, Maryland, 21201
St. Agnes Hospital
Baltimore, Maryland, 21229
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
New York Methodist Hospital
Brooklyn, New York, 11215
Disney Family Cancer Center
Burbank, California, 91505
Medical University of South Carolina
Charleston, South Carolina, 29425
The University of Illinois at Chicago
Chicago, Illinois, 60612
The Christ Hospital Cancer Center
Cincinnati, Ohio
Cookeville Regional Cancer Center
Cookeville, Tennessee, 38501
Gershenson Radiation
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010
Veterans Administration NJ Health Care System
East Orange, New Jersey, 07018
Southcoast Hospital Group
Fairhaven, Massachusetts, 02719
Kirkland Cancer Center/Jackson Madison County General Hospital
Jackson, Tennessee, 38301
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
University of Kentucky
Lexington, Kentucky, 40536
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
VA Long Beach Health System
Long Beach, California, 90822
University of Louisville
Louisville, Kentucky, 40202
Medical College of Wisconson
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Yale University School of Medicine
New Haven, Connecticut, 06520
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Beth Israel Medical Center
New York, New York, 10003
Helen F. Graham Cancer Center
Newark, Delaware, 19178
The Whittingham Cancer Center, Norwalk Hospital
Norwalk, Connecticut, 06856
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
The Nebraska Medical Center
Omaha, Nebraska, 68198
Memorial Hospital of Rhode Island Cancer Center
Pawtucket, Rhode Island, 02860
Arizona Center for Cancer Care
Peoria, Arizona, 85381
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013
Pomona Valley Hospital
Pomona, California, 91767
Providence Portland Medical Center
Portland, Oregon, 97213
Rochester University Medical Center
Rochester, New York, 14642
Virginia Mason Medical Center
Seattle, Washington, 98101
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
Washington University in St. Louis
St Louis, Missouri, 63110
Mount Nittany Medical Center
State College, Pennsylvania, 16803
Lake County Oncology and Hematology
Tavares, Florida, 32778
Montefiore Medical Center
The Bronx, New York, 10467
Arizona Clinical Research Center
Tucson, Arizona, 85715
Tyler Hematology Oncology
Tyler, Texas, 75701
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
Wheeling Hospital
Wheeling, West Virginia, 26003
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy
This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.
- Conditions
- Oral Mucositis
- Being tested
- SCV-07, Placebo
- Keywords
- Oral Mucositis, Head and Neck, Head and Neck Neoplasms, Mucositis, Stomatitis, Neoplasms by Site, Neoplasms, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Mouth Diseases, Stomatognathic Diseases, SCV-07
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms, Mucositis, Neoplasms by Site, Neoplasms, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCV-07Drug
clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| SCV-07 0.1mg/kg | Active comparator | Not described Receives: Drug: SCV-07 |
| SCV-07 0.3mg/kg | Active comparator | Not described Receives: Drug: SCV-07 |
| SCV-07 1.0mg/kg | Active comparator | Not described Receives: Drug: SCV-07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
The primary objective of the study is to evaluate the efficacy of SCV 07 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent ChemoRT.
Measured: June 2012
Secondary outcomes (1)
Safety
The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.
Measured: June 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Israel Rios, MD, Study director, SciClone Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247246
- Sponsor's protocol ID
- SCI-SCV-MUC-P2b-002
- Status last verified
- May 2014
- First submitted
- 22 Nov 2010
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy
- ClinicalTrials.gov ID
- NCT01247246
- Acronym / sponsor ID
- SCI-SCV-MUC-P2b-002
- Conditions
- Oral Mucositis
- Keywords
- Oral Mucositis, Head and Neck, Head and Neck Neoplasms, Mucositis, Stomatitis, Neoplasms by Site, Neoplasms, Gastroenteritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| SCV-07 0.1mg/kg | Active comparator | Drug: SCV-07 |
| SCV-07 0.3mg/kg | Active comparator | Drug: SCV-07 |
| SCV-07 1.0mg/kg | Active comparator | Drug: SCV-07 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Willing and able to understand and sign an informed consent form (ICF) for the study approved by the Investigator's local or a central Institutional Review Board (IRB)
- Have recently diagnosed, pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx, or larynx that will be treated with ChemoRT as first-line treatment; subjects with a history of surgical management 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 50 and 72 Gy. Planned radiation treatment fields must include at least 2 oral sites (buccal mucosa, floor of oral cavity, tongue, or soft palate), with each site receiving ≥ 50 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)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Key exclusion criteria (17 listed)
- Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
- Metastatic disease (M1) Stage IV C
- Prior radiation to the head and neck
- Plan to be treated with cetuximab (Erbitux®)
- Have undergone induction CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCV-07clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc | Drug | SCV-07 0.1mg/kg, SCV-07 0.3mg/kg, SCV-07 1.0mg/kg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Efficacy
Time frame: June 2012
The primary objective of the study is to evaluate the efficacy of SCV 07 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent ChemoRT.
1 secondary outcome
Safety
Time frame: June 2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- SciClone Pharmaceuticals, Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel Rios, MD study director
SciClone Pharmaceuticals
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCV-07 in people with Oral Mucositis, run by SciClone Pharmaceuticals at 49 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: June 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.