Ongoing Clinical Trials Actively Recruiting Patients With Intraocular Cancer


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The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies of children and adults with intraocular cancers. The studies include pilot, phase 0, phase I, phase II, and observational trials evaluating new combination therapies, vaccines, optical coherence tomography, molecular analysis of retinoblastoma, and radiation therapy in patients with newly diagnosed, advanced, and refractory disease. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.

PILOT

Study Type: Pilot study/interventoinal/nonrandomized

Study Title: A Pilot Study of Intravenous Topotecan and Vincristine in Combination With Subconjunctival Carboplatin for Patients With a History of Bilateral Retinoblastoma and Refractory/Recurrent Intraocular Disease

Study Sponsor and Collaborators: Children’s Hospital Medical Center, Cincinnati

Purpose: To test subtenon carboplatin in combination with vincristine and topotecan intravenously to find a drug combination that may be effective against retinoblastoma that is recurrent or is resistant to other treatment

Ages Eligible for Study: Up to 10 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To estimate the event-free survival, where an event is defined at the ocular level as the need for non-protocol therapy defined as additional nonprotocol chemotherapy, external beam radiation, or enucleation (time frame: at 1 year)

Principal Investigator: James Geller, MD, Children’s Hospital Medical Center, Cincinnati, 513-636-6312, james. geller@cchmc.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00980551

Study Type: Interventional/nonrandomized

Study Title: A Pilot Study Evaluating the Safety of Alternating Systemic Chemotherapy and Intra-Arterial Melphalan Chemotherapy in Children With Newly Diagnosed Advanced Intra-Ocular Retinoblastoma

Study Sponsor and Collaborators: University of California, San Francisco

Purpose: To test the safety of the treatment combination of alternating standard chemotherapy and another (melphalan) chemotherapy at different interval schedules

Ages Eligible for Study: 4 months and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Adverse event evaluation for newly diagnosed advanced retinoblastoma treated with melphalan therapy and systemic chemotherapy (time frame: up to 2 years)

Principal Investigator: Katherine Matthay, MD, University of California, San Francisco, 415-476-3831, matthayk@peds.ucsf.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02116959

PHASE 0

Study Type: Phase 0/interventional/nonrandomized

Study Title: Anti-Angiogenic Therapy After Autologous Stem Cell Rescue (ASCR) for Relapsed and Refractory Pediatric Solid Tumors

Study Sponsor and Collaborators: Washington University School of Medicine

Purpose: To determine whether taking either of two low-dose drugs, metronomic cyclophosphamide and thalidomide, that would prevent new blood vessels from growing after stem cell transplant is feasible, and what the side effects of taking each of these drugs after autologous transplant might be

Ages Eligible for Study: 1 to 21 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Safety (time frame: minimum of 2 years after initiation of study treatment); toxicity (time frame: minimum of 2 years after initiation of study treatment)

Principal Investigator: Lisa Madden, MD, Washington University School of Medicine, 314-454-6018, madden_l@kids.wustl.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01661400

PHASE I

Study Type: Phase I/interventional/single-group assignment

Study Title: Sirolimus in Combination With Metronomic Therapy in Children With Recurrent and Refractory Solid Tumors: A Phase I Study

Study Sponsor and Collaborators: Emory University; Children’s Healthcare of Atlanta

Purpose: This study proposes using sirolimus in combination with common chemotherapy drugs to treat patients with recurrent and refractory solid tumors. The study will investigate the highest dose of sirolimus that can be given orally with other oral chemotherapy drugs.

Ages Eligible for Study: Up to 30 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Maximum tolerated dose (time frame: 2 years after treatment starts)

Principal Investigator: Muna Qayed, MD, Children’s Healthcare of Atlanta. Contact: Sindy Moon, 404-785-1441, sindy.moon@choa.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT013311135

PHASE II

Study Type: Phase II/interventional/randomized

Study Title: A Randomized Two-Arm Phase II Study of Trametinib Alone and in Combination With GSK2141795 in Patients With Advanced Uveal Melanoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To investigate how well trametinib with or without Akt inhibitor GSK2141795 works in treating patients with metastatic uveal melanoma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Time to progression (progression-free survival), defined from the date of randomization to the date of documented progression or death per Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: time from randomization to the earlier date of objective disease progression, assessed up to 12 months)

Principal Investigator: Richard Carvajal, MD, Memorial Sloan Kettering Cancer Center, 646-888-4161, carvajar@mskcc.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01979523

Study Type: Phase II/interventional/randomized

Study Title: A Phase II, Open-Label, Multicenter, Randomized Study of CDX-1401, a Dendritic Cell Targeting NY-ESO-1 Vaccine, in Patients With Malignant Melanoma Pre-treated With Recombinant CDX-301, a Recombinant Human Flt3 Ligand

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study how well DEC-205/NY-ESO-1 fusion protein CDX-1401 (CDX-1401) and neoantigen-based melanoma-poly-ICLC vaccine (poly-ICLC) vaccine therapy work when given with or without recombinant flt3 ligand (CDX-301) in treating patients with stage IIB-IV melanoma

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Immune T-cell response to NY-ESO-1 (time frame: up to 12 weeks after final vaccination)

Principal Investigator: Nina Bhardwaj, MD, PhD, Mount Sinai Medical Center, 212-824-8427, nina.bhardwaj@mssm.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02129075

Study Type: Phase II/interventional/single-group assignment

Study Title: A Phase II Pilot Trial of an Indoleamine 2,3, Dioxygenase-1 (IDO1) Inhibitor (INCB024360) Plus a Multipeptide Melanoma Vaccine (MELITAC 12.1) in Patients With Advanced Melanoma

Study Sponsor and Collaborators: Fred Hutchinson Cancer Research Center; National Cancer Institute

Purpose: To study how well INCB024360 (indoleamine 2,3-dioxygenase 1 [IDO1] inhibitor INCB024360) and vaccine therapy work in treating patients with stage III-IV melanoma.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Changes in the concentration and number of CD8+ and CD4+ specific T-cell immune responses by IFN-gamma ELISPOT (time frame: baseline to up to 16 weeks)

Principal Investigator: Craig L. Slingluff, MD, Cancer Immunotherapy Trials Network, 434-924-1730

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01961115

Study Type: Phase II/interventional/single-group assignment

Study Title: Phase II Study of Intrathecal I-3F8 in Patients With GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center

Purpose: To study the side effects and how well iodine l 131 monoclonal antibody 3F8 works in treating patients with central nervous system cancer or leptomeningeal cancer

Ages Eligible for Study: N/A

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Six-month overall survival (time frame: 6 months)

Principal Investigator: Kim Kramer, MD, Memorial Sloan Kettering Cancer Center, 212-639-6410

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00445965

Study Type: Phase II/interventional/single-group assignment

Study Title: An Open-label, Single Institution Phase II Study Using Radioactive yttrium90 Microsphere (SIR-Spheres Microspheres) in Uveal Melanoma Patients With Hepatic Metastasis

Study Sponsor and Collaborators: Thomas Jefferson University

Purpose: To determine whether radiation provided locally to the liver tumor environment will demonstrate a response of tumor decline.

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Clinical benefit rate of previously treated and naïve patients (time frame: 3 months post final treatment)

Principal Investigator: Carin Gonsalves, MD, Thomas Jefferson University. Contact: Mary Ann Laudadio, RN, 215-955-9980, mary.ann.laudadio@jefferson.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01473004

Study Type: Phase II/interventional/single-group assignment

Study Title: Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center

Purpose: To study whether chemotherapy delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment alternative to conventional systemic chemotherapy, external beam radiation, and surgical removal of the eye

Ages Eligible for Study: Up to 18 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Number of patients who complete therapy without the need for additional treatment, including systemic chemotherapy, external beam radiation, or enucleation (time frame: within the first 6 months after the initial treatment)

Principal Investigator: Monica Pearl, MD, The Johns Hopkins Hospital, 410-955-8525, msmit135@jhmi.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01293539

Study Type: Phase II/interventional/nonrandomized

Study Title: Phase II Study in Patients With Metastatic Ocular Melanoma Using a Non-Myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Autologous Tumor-Infiltrating Lymphocytes With or Without High Dose Aldesleukin

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To determine if chemotherapy and white blood cell therapy is a safe and effective treatment for advanced ocular melanoma.

Ages Eligible for Study: 16 to 75 years

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: To determine whether autologous Young TIL infused plus or minus the administration of high-dose IL-2 may result in clinical tumor regression in patients with metastatic ocular melanoma receiving a nonmyeloablative lymphoid depleting preparative regimen (time frame: 3 years)

Principal Investigator: Udai S. Kammula, MD, National Cancer Institute, 301-435-8606, kammulau@mail.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01814046

Study Type: Phase II/interventional/single-group assignment

Study Title: A Phase 2 Study of Vorinostat (NSC 701852) in Metastatic Uveal Melanoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study how well vorinostat works in treating patients with melanoma of the eye that has metastasized

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Overall response rate in patients with GNAQ/GNA11 mutant uveal melanoma, defined as the rate of complete and partial responses (time frame: up to 3 years)

Principal Investigator: Richard Carvajal, MD, Memorial Sloan Kettering Cancer Center, 646-888-4161, carvajar@mskcc.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01587352

Study Type: Phase II/interventional/randomized

Study Title: Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To investigate how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Progression-free survival rate (time frame: at 4 months)

Principal Investigator: Jason Luke, MD, Cancer and Leukemia Group B. Contact: NCI CTRP, 866-319-4357, ncictro@mail.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01835145

OBSERVATIONAL

Study Type: Observational

Study Title: Characterization of Small Choroidal Tumors Using Functional Optical Coherence Tomography

Study Sponsor and Collaborators: Oregon Health and Science University

Purpose: To study whether mapping blood vessel patterns with optical coherence tomography (OCT) will help identify life-threatening choroidal tumors in their early stages and improve overall patient survival through early detection

Ages Eligible for Study: 18 years and older

Genders Eligible for Study: Both

Accepts Health Volunteers: No

Primary Outcome Measures: Blood vessel patterns in small choroidal tumors (time frame: 24 months)

Principal Investigator: Alison Skalet, MD, PhD, Oregon Health and Science University. Contact Denny Romfh, 503-494-4351, romfhd@ohsu.edu

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01955915

Study Type: Observational

Study Title: Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies

Study Sponsor and Collaborators: National Cancer Institute

Purpose: Laboratory investigators studying common childhood cancers are interested in developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of children who have cancer or adults who have common childhood cancers. The cancers include retinoblastoma.

Ages Eligible for Study: N/A

Genders Eligible for Study: Both

Accepts Health Volunteers: Yes

Primary Outcome Measures: N/A

Principal Investigator: Javed Khan, MD, National Cancer Institute, 301-435-2937, khanjav@mail.nih.gov

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01109394 ■



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