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Alkylating Agent
Sunitinib + Tamoxifen + Cisplatin for Ocular Melanoma
Phase 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
High-risk disease, defined by large choroidal tumors with a basal diameter ≥ 16 mm and/or tumor thickness ≥ 10 mm (T3), extrascleral extension (T4), ciliary body involvement, or epithelioid cell type only
No measurable metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing sunitinib given with tamoxifen and cisplatin to see if it is more effective than tamoxifen and cisplatin alone in treating patients with ocular melanoma.
Who is the study for?
This trial is for patients with high-risk ocular melanoma who've had initial treatment. They must have good blood counts, organ function, and no recent other cancers except certain skin or cervical cancers. Pregnant or nursing individuals can't join, and participants must use contraception if fertile.Check my eligibility
What is being tested?
The study tests combining Sunitinib (a drug that blocks tumor blood flow and growth enzymes) with chemotherapy drugs Tamoxifen and Cisplatin to see if they're more effective together in treating high-risk ocular melanoma.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, kidney issues from Cisplatin; hot flashes or mood swings from Tamoxifen; and hypertension or bleeding risks from Sunitinib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye tumor is large, has spread beyond the eye, involves the ciliary body, or is of epithelioid type.
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My cancer has not spread to distant parts of my body that can be measured.
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My kidney function is normal or only slightly impaired.
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My pancreatic enzymes are within normal range.
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I do not have heart failure that needs medication.
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I do not have any current infections.
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I haven't had a blood clot in the last 6 months.
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I can take care of myself and perform daily activities.
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My thyroid function is normal, or I am on stable thyroid medication.
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I have not had a heart attack in the last 6 months.
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I do not have trouble breathing when I am resting.
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I have received initial treatment for eye melanoma.
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I have been diagnosed with eye melanoma.
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I haven't had any cancer in the last 5 years, except for skin or cervical cancer.
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I have never needed extra oxygen for a lung problem.
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
Disease-free survival
Overall survival
Toxicity
Find a Location
Who is running the clinical trial?
San Diego Pacific Oncology & Hematology AssociatesLead Sponsor
3 Previous Clinical Trials
334 Total Patients Enrolled
Edward F. McClay, MDPrincipal InvestigatorSan Diego Pacific Oncology & Hematology Associates
3 Previous Clinical Trials
334 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently undergoing any other cancer treatments.My eye tumor is large, has spread beyond the eye, involves the ciliary body, or is of epithelioid type.My cancer has not spread to distant parts of my body that can be measured.My kidney function is normal or only slightly impaired.You need to have a test that shows you are not pregnant.My pancreatic enzymes are within normal range.I do not have heart failure that needs medication.I do not have any current infections.I haven't had a blood clot in the last 6 months.I can take care of myself and perform daily activities.Your ANC (absolute neutrophil count) is at least 1,200 per cubic millimeter.My thyroid function is normal, or I am on stable thyroid medication.Your heart pumps blood normally.I have not had a heart attack in the last 6 months.I do not have trouble breathing when I am resting.I have received initial treatment for eye melanoma.I have previously been treated with sunitinib, tamoxifen, or cisplatin.Your AST and ALT levels in your blood are not more than three times the upper limit of normal.Your hemoglobin level is at least 9.0 grams per deciliter.Your platelet count is at least 100,000 per cubic millimeter.I have been diagnosed with eye melanoma.I haven't had any cancer in the last 5 years, except for skin or cervical cancer.I have never needed extra oxygen for a lung problem.
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.
What is the current capacity of this medical experiment for participants?
"As per clinicaltrials.gov, this study is not taking on new patients at present. It was initially advertised in May 2007 and last updated in January 2014; however there are presently 754 other trials recruiting individuals for participation."
Answered by AI
Has this remedy been given the green light by the FDA?
"With limited data indicating its safety, this treatment received an estimated score of 2. The trial is currently in Phase 2, which means that there has been no clinical evidence supporting efficacy yet."
Answered by AI
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