Oral MucositisPhase 2SCV-07 OMNCT00756951
Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer
A Phase 2 study testing SCV-07 in people with Oral Mucositis and Head and Neck Cancer, run by SciClone Pharmaceuticals at 19 sites in United States.
Trial summary
Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Head and Neck Cancer
- What is being tested?
- SCV-07
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 19 sitesUnited States
- Study dates
- Sep 2008to not given
- 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
- Subject must have a body weight less than 150 kg at screening
- Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is < 6 weeks prior to initiation of radiotherapy.
- Plan to receive a continuous course of conventional external beam irradiation
- Plan to receive a standard cisplatin chemotherapy regimen
Who cannot join
- Pregnant or breastfeeding
- Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor
- Prior radiation to the head and neck
- Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
- Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
- Have current oral mucositis
Show all 11Show fewer
- Presence of active infectious disease excluding oral candidiasis
- Chronic immunosuppression
- Seropositive for HIV or hepatitis B surface antigen or C antibody
- Used an investigational agent within 30 days of randomization
- Have a known sensitivity to any investigational agent
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
St Luke's Hospital & Health Network
Bethlehem, Pennsylvania, 18015
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Illinois at Chicago
Chicago, Illinois, 60612
Ohio State University Medical Center
Columbis, Ohio, 43210
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
James Graham Brown Cancer Center
Lousiville, Kentucky, 40202
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Beth Israel Medical Center
New York, New York, 10003
Helen F Graham Cancer Center
Newark, Delaware, 19713
Whittingham Cancer Center
Norwalk, Connecticut, 06856
The Nebraska Medical Center
Omaha, Nebraska, 68198
Temple University
Philadelphia, Pennsylvania, 19140
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013
Washington University in St Louis
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.
Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer.
The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.
- Conditions
- Oral Mucositis, Head and Neck Cancer
- Being tested
- Placebo, SCV-07
- Keywords
- SCV-07, Oral Mucositis
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
SCV-07Drug
0.02 mg/kg
SCV-07Drug
0.10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2 | Active comparator | SCV-07 at a dose of 0.02 mg/kg Receives: Drug: SCV-07 |
| 3 | Active comparator | SCV-07 at a dose of 0.10 mg/kg Receives: Drug: SCV-07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy.
Measured: 7 Weeks
Efficacy of Oral Mucositis assessment will be completed by trained site personnel. The WHO score will be the primary measure and NCI CTCAE will be a secondary measure for assessing Oral Mucositis.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startSep 2008
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Israel Rios, MD, Study director, SciClone Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756951
- Sponsor's protocol ID
- SCI-SCV-MUC-P2-001
- Acronym
- SCV-07 OM
- Status last verified
- Dec 2008
- First submitted
- 12 Sep 2008
- Last updated
- 23 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.
- ClinicalTrials.gov ID
- NCT00756951
- Acronym / sponsor ID
- SCV-07 OM / SCI-SCV-MUC-P2-001
- Conditions
- Oral Mucositis, Head and Neck Cancer
- Keywords
- SCV-07, Oral Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- First posted
- 22 Sep 2008 (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.
Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer.
The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
| 2 | Active comparator | Drug: SCV-07SCV-07 at a dose of 0.02 mg/kg |
| 3 | Active comparator | Drug: SCV-07SCV-07 at a dose of 0.10 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must have a body weight less than 150 kg at screening
- Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is < 6 weeks prior to initiation of radiotherapy.
- Plan to receive a continuous course of conventional external beam irradiation
- Plan to receive a standard cisplatin chemotherapy regimen
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding
- Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor
- Prior radiation to the head and neck
- Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
- Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
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 |
|---|---|---|
| PlaceboPlacebo | Drug | 1 |
| SCV-070.02 mg/kg | Drug | 2 |
| SCV-070.10 mg/kg | Drug | 3 |
Primary outcome
Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy.
Time frame: 7 Weeks
Efficacy of Oral Mucositis assessment will be completed by trained site personnel. The WHO score will be the primary measure and NCI CTCAE will be a secondary measure for assessing Oral Mucositis.
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2009.
- Related InfoLink 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
19 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 and Head and Neck Cancer, run by SciClone Pharmaceuticals at 19 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 23 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy. (time frame: 7 Weeks). The study lists 2 primary outcomes in all. 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 23 Nov 2009.