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 - NCT00756951-10003 (Clinical Trial 242773)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy242773.aspx
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New York |
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State:
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NY |
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10003 |
| Conditions: |
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Oral Mucositis - Head and Neck Cancer |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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 |
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| Study is available at: |
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Beth Israel Medical Center
New York, NY 10003
United States
Primary Contact:
Mahesh Kumar
Email: mkumar@chpnet.org
Phone: 212-844-8030
Secondary Contact:
Beth Rayworth, M.S.
Email: brayworth@captrials.com
Phone: 508-620-2700 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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