A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma - NCT00395070-60099 (Clinical Trial 154643)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy154643.aspx
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| City: |
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Zion |
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State:
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IL |
| Zip Code: |
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60099 |
| Conditions: |
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Metastatic Melanoma |
| Purpose: |
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To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide
(TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.
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| Study summary: |
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Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an
investigational product designed to train your body's immune system to recognize and destroy
tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or
temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a
minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for
six weeks followed by two weeks of observation and assessments. For patients who receive the
chemotherapy alone, their treatment course will follow standard dosing. During the trial all
patients' tumors will be closely monitored. Patients whose melanoma does not clinically
progress will be encouraged to continue on the treatment and be assessed for up to two
years. |
| Criteria: |
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Inclusion Criteria (Potential study participants must meet the following criteria):
- Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via
surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)
- At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a
dime) and can be injected
- Normal blood chemistries and blood cell counts
- At least 18 years old and able and willing to provide informed consent to participate
Exclusion Criteria (Potential study participants will not be eligible with the following):
- Previous chemotherapy treatment for melanoma
- Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)
- If surgical removal of all lesions would be possible and could be curative
- Any melanoma tumors greater than 10cm x 10cm in size
- Known condition resulting in a suppressed immune system
- Female subjects who are pregnant |
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| Study is available at: |
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Location #96
Zion, IL 60099
United States
Primary Contact:
Dmitri Kharkevitch, MD,PHD
Email: melanoma@vical.com
Phone: 858-646-1164 or 1-877-343-6389 |
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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 15, 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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