Search Cancer Clinical Trials
Search our clinical trials database by disease type, trial number, location or phase. Must press "Go" to activate search.
Adjuvant Therapy for Patients with Primary Uveal Melanoma with Genetic Imbalance
- Primary: Assess disease-free survival (DFS) with sequential dacarbazine and interferon-alfa-2b as an adjuvant to primary therapy for patients with uveal melanoma with genetic imbalance.
- Evaluate side effects and assess safety in the patient population.
- Examine the relationship between the levels of plasma biomarkers of immune function and tumor invasion and the clinical outcome.
- Patients must have a diagnosis, either cytologic or histologic, of melanoma of the iris, ciliary body and/or choroid
- Patient's tumor must exhibit monosomy 3 and/or 8q amplification as determined by karyotype, CGH, PCR-based FISH, and/or other equivalent analysis. Tissue or cells for analysis can be obtained at enucleation, resection, or by FNA.
- Patients must have undergone adequate primary therapy. This can include enucleation, brachytherapy, proton beam radiotherapy, stereotactic irradiation, trans-scleral local resection, trans-retinal resection or diode laser thermotherapy.
- Patients must have had chest X-ray and hepatic ultrasound or other imaging methods such as CT or MRI to eliminate distant disease.
- Patients must have a performance status (ECOG) of < 2.
- Patients must be entered within 56 days of completing primary therapy.
- Patients must have the following pretreatment laboratory findings:
- WBC ≥ 3.0 x 109/L
- Neutrophils ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- INR and PTT < 1.5x upper limit of normal
- Hemoglobin ≥ 10 gm/100 ml
- Creatinine ≤ 2 mg/dl
- Bilirubin (total) ≤ 1.5 mg/dl
- ALT ≤ 1.5x upper limit of normal
- AST ≤ 1.5x upper limit of normal
- Alkaline phosphatase ≤ 1.5x upper limit of normal
- Patients must not have received any other systemic therapy for melanoma.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines. A copy of the informed consent document signed by the patient must be given to the patient.
- Patients with metastasis.
- Patients that are pregnant or breastfeeding
- Patients may not be receiving any other investigational agents.
- Patients with a history of immunodeficiency or autoimmune diseases are not eligible. Patients requiring therapy with corticosteroids or other immunosuppressives are not eligible. Patients requiring ongoing replacement therapy with physiologic doses of corticosteroids will be eligible.
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are not eligible.
- Patients who are known to be positive for HIV or HepBAg.
- No patient may have had a malignancy other than a malignant melanoma, with the following exceptions:
- Basal or squamous cell carcinomas of the skin
- Carcinoma in-situ of the uterine cervix
- Any malignancy treated with curative intent and in complete remission for > 3 years.
- Patients with organ allografts.
Download the Cleveland Clinic Cancer Clinical Trials App
Stay up to date on Cleveland Clinic’s more than 200 active clinical trials for cancer patients. Our free Cancer Clinical Trials app is available for Apple and Android devices.
With this app, you can:
- Search our real time database for trials by disease, phase, physician or hospital location
- Browse information on each trial’s objective, eligibility criteria, stage(s) and more
- Connect to our Cancer Answer Line for more information about a trial or to enroll patients
The app also includes contacts for patient resources, financial services information, support groups and treatment guides.
Cancer Answers & Appointments
Speak with a cancer nurse specialist for appointment assistance and for answers to your questions about cancer locally at 216.444.7923 or toll-free 1.866.223.8100.
Monday through Friday from 8 a.m. – 4:30 p.m. (ET).
Resources for medical professionals
- Outpatient appointment referrals: 216.444.7923 or 866.223.8100
- Inpatient hospital transfers: 800.553.5056
- Referring Physician Concierge: 216.444.6196 or 216.312.4910.
Search available cancer clinical trials by disease, hospital, phase or number.
This information is provided by Cleveland Clinic and is not intended to replace
the medical advice of your doctor or health care provider.
Please consult your health care provider for advice about a specific medical condition.
© Copyright 2016 Cleveland Clinic. All rights reserved.