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Monoclonal Antibodies
Triple Drug Therapy for Melanoma
Phase 1 & 2
Waitlist Available
Led By Edward F. McClay, MD
Research Sponsored by San Diego Pacific Oncology & Hematology Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Metastatic disease
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying the side-effects and best dose of the combination of drugs sorafenib, bevacizumab, and oxaliplatin in treating patients with metastatic malignant melanoma.
Who is the study for?
This trial is for patients with metastatic malignant melanoma. They should have a certain level of physical fitness (ECOG 0-2), a life expectancy of at least 3 months, and adequate organ function. Pregnant or nursing women can't join, and participants must use contraception if fertile. Those with active brain metastases, other serious illnesses, recent heart issues, or who've had certain treatments recently are excluded.Check my eligibility
What is being tested?
The study is testing the combination of Sorafenib (an enzyme blocker), Bevacizumab (a monoclonal antibody that blocks blood flow to tumors), and Oxaliplatin (chemotherapy). It aims to find the best dose of Sorafenib when used with Bevacizumab and Oxaliplatin in treating advanced skin cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions like fever or chills during treatment administration, fatigue from energy depletion, digestive disturbances like nausea or diarrhea, blood cell count changes leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread to other parts of my body.
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I can take care of myself and perform daily activities.
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My cancer can be measured or seen outside of my brain and spinal cord.
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My melanoma diagnosis was confirmed through tissue examination.
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It has been over 6 weeks since my last radiation treatment.
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My kidney function is normal or only slightly impaired.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin
Overall survival
Progression-free survival
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Who is running the clinical trial?
San Diego Pacific Oncology & Hematology AssociatesLead Sponsor
3 Previous Clinical Trials
330 Total Patients Enrolled
Edward F. McClay, MDPrincipal InvestigatorSan Diego Pacific Oncology & Hematology Associates
3 Previous Clinical Trials
330 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.It's been over 3 weeks since my last chemotherapy and 6 weeks since my last radiotherapy for brain disease.It has been over 4 weeks since my last surgery.I do not have any active cancer spread to my brain.You are expected to live for at least 3 more months.I have previously been treated with sorafenib, bevacizumab, or oxaliplatin.Your ANC (absolute neutrophil count) is at least 1,200 per cubic millimeter.I currently have an infection.I have a long-term immune system disorder.I haven't had any cancer except for skin or cervical cancer in the last 5 years.I have not had heart failure or a heart attack in the last 6 months.I have previously received chemotherapy.You have to have a test that shows you are not pregnant.I can take care of myself and perform daily activities.Your heart test doesn't show any serious heart rhythm problems or recent heart attack.Your platelet count is at least 100,000 per cubic millimeter.My cancer can be measured or seen outside of my brain and spinal cord.My melanoma diagnosis was confirmed through tissue examination.It has been over 6 weeks since my last radiation treatment.I have treated brain metastases but also have measurable cancer outside my brain.Your bilirubin level in your blood should be less than 3.0 milligrams per deciliter.I have had biological therapy before.I am not on any biological therapy except for treatments for blood cell issues.I am not currently undergoing radiotherapy, chemotherapy, or surgery.My kidney function is normal or only slightly impaired.I have cancer that spread after radiation but no other cancer spread.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment of participants currently underway for this research project?
"As indicated on clinicaltrials.gov, this particular medical study is not currently recruiting subjects - the initial posting being dated May 1st 2007 and its last update occurring January 9th 2014. However, there are 758 other trials actively seeking participants at present."
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