Clinical trial · Interventional
Sunitinib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Ocular Melanoma
A Phase II Pilot Trial of Sutent, Tamoxifen, and Cisplatin in Patients With High-Risk Ocular Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with tamoxifen and cisplatin may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving sunitinib together with tamoxifen and cisplatin works in treating patients with high-risk ocular melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Disease-free survival
- measure
- Overall survival
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of ocular melanoma
* High-risk disease, defined by any of the following:
* Large choroidal tumors with a basal diameter ≥ 16 mm and/or tumor thickness ≥ 10 mm (T3)
* Extrascleral extension (T4)
* Ciliary body involvement
* Epithelioid cell type only
* Have undergone appropriate primary treatment for ocular melanoma
* No measurable metastatic disease
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* ANC ≥ 1,200/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
* AST and ALT ≤ 3 times upper limit of normal
* Pancreatic enzymes normal
* Thyroid function normal or stable on replacement therapy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Cardiac ejection fraction ≥ 50% by MUGA or ECHO
* No myocardial infarction within the past 6 months
* No congestive heart failure requiring medication
* No history of pulmonary disease requiring supplemental oxygen
* No dyspnea at rest
* No active infection
* No chronic underlying immunodeficiency disease
* No other serious illness that would preclude patient safety, in the opinion of the investigator
* No other cancer within the past 5 years except nonmelanoma skin cancer or cervical cancer
* No thromboembolic disease within the past 6 months
PRIOR CONCURRENT THERAPY:
* No prior sunitinib malate, tamoxifen citrate, or cisplatin
* No other concurrent chemotherapy, radiotherapy, or surgeryReferences
Publications (0)
Data not yet available