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Pilot Study of Sequential Hepatic Radioembolization and Systemic Ipilimumab in Patients With Uveal Melanoma Metastatic to Liver


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size, Extraocular Extension Melanoma, Iris Melanoma, Liver Metastases, Metastatic Intraocular Melanoma, Recurrent Intraocular Melanoma, Stage IV Intraocular Melanoma

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Trial Information

Pilot Study of Sequential Hepatic Radioembolization and Systemic Ipilimumab in Patients With Uveal Melanoma Metastatic to Liver


PRIMARY OBJECTIVE:

I. To estimate the safety and efficacy of sequential hepatic radioembolization and systemic
ipilimumab in patients with uveal melanoma metastatic to liver.

SECONDARY OBJECTIVES:

I. To evaluate effects on regulators of tumor immunity.

OUTLINE:

Patients undergo radioembolization with yttrium Y 90 glass microspheres via hepatic arterial
infusion on day 1. Beginning on day 29, patients also receive ipilimumab intravenously (IV)
over 90 minutes. Treatment with ipilimumab repeats every 3 weeks for up to 4 courses in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.


Inclusion Criteria:



- Histologic diagnosis of metastatic uveal melanoma; the tumor biopsy/aspiration must
be available for review

- Patients must have measurable disease as defined by Response Evaluation Criteria in
Solid Tumors (RECIST)

- Patients must have liver metastasis

- No more than one prior systemic therapeutic regimen; this includes chemotherapy,
biologic therapy, biochemotherapy, or investigational treatment; this does not
include any therapies given in the adjuvant setting

- No concomitant therapy with any of the following: interleukin-2 (IL-2), interferon,
or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive
agents; other investigation therapies; or chronic use of systemic corticosteroids;
must have been discontinued > 4 weeks

- Patients with prior hepatic embolization procedures are eligible as long as they are
candidates for repeat procedures and they have demonstrated progressive disease

- No infection with human immunodeficiency virus (HIV); due to the mechanism of action
of ipilimumab, activity and side effects in an immune compromised patient are unknown

- No active infection with hepatitis B

- No active or chronic infection with hepatitis C

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Women must not be pregnant or breast-feeding due to unknown effects of treatments on
the unborn fetus; all women of childbearing potential must have a blood test within
72 hours prior to randomization to rule out pregnancy; women of childbearing
potential and sexually active males must be strongly advised to use an accepted and
effective method of contraception; women of childbearing potential (WOCBP) must be
using an adequate method of contraception to avoid pregnancy throughout the study and
for up to 12 weeks after the last dose of investigational product, in such a manner
that the risk of pregnancy is minimized; sexually mature females who have not
undergone a hysterectomy or who have not been postmenopausal naturally for at least
24 consecutive months (i.e., who have had menses at some time in the preceding 24
consecutive months) are considered to be of childbearing potential; women who are
using oral contraceptives, other hormonal contraceptives (vaginal products, skin
patches, or implanted or injectable products), or mechanical products such as an
intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent
pregnancy, or are practicing abstinence or where their partner is sterile (e.g.,
vasectomy) should be considered to be of childbearing potential

- White blood cell (WBC) >= 2000/uL

- Absolute neutrophil count (ANC) >= 1500/mcL

- Platelets >= 100,000/mcL

- Hemoglobin >= 8 g/dL

- Creatinine =< 3.0 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN

- Bilirubin =< 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a
total bilirubin less than 3.0 mg/dL)

- Albumin >= 3 g/dL

Exclusion Criteria:

- Patients are excluded if they have liver tumor volume > 50%

- Patients are excluded if they have any history of central nervous system (CNS)
metastases

- Patients are excluded if they have a history of any other malignancy from which the
patient has been disease-free for less than 2 years, with the exception of adequately
treated and cured basal or squamous cell skin cancer, superficial bladder cancer or
carcinoma in situ of the cervix

- Patients are excluded if they have a history of autoimmune disease, as follows:
patients with a history of inflammatory bowel disease are excluded from this study as
are patients with a history of symptomatic disease (e.g., rheumatoid arthritis,
systemic progressive sclerosis [scleroderma], systemic lupus erythematosus,
autoimmune vasculitis [e.g., Wegener's granulomatosis]); patients with motor
neuropathy considered of autoimmune origin (e.g., Guillain- Barre syndrome and
myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis
are eligible if their current thyroid disorder is treated and stable with replacement
or other medical therapy

- Patients are excluded for any underlying medical or psychiatric condition, which in
the opinion of the investigator, will make treatment hazardous or obscure the
interpretation of adverse events, such as a condition associated with frequent
diarrhea

- Patients are excluded if they have a history of prior treatment with ipilimumab or
prior tumor necrosis factor receptor superfamily, member 9 (CD137) agonist or
cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor or agonist

- Patients are excluded for receiving any non-oncology vaccine therapy used for
prevention of infectious diseases for up to four weeks (28 days) prior to or after
any dose of ipilimumab

- Patients are excluded if they have any concurrent medical condition requiring the use
of systemic steroids (the use of inhaled or topical steroids is permitted)

- Patients are excluded if they have a functional organ transplant

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients that experience grade 3-4 toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

Outcome Time Frame:

Up to 3 weeks after discontinuation of study treatment

Safety Issue:

Yes

Principal Investigator

Pierre Triozzi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE1612

NCT ID:

NCT01730157

Start Date:

December 2012

Completion Date:

Related Keywords:

  • Ciliary Body and Choroid Melanoma, Medium/Large Size
  • Ciliary Body and Choroid Melanoma, Small Size
  • Extraocular Extension Melanoma
  • Iris Melanoma
  • Liver Metastases
  • Metastatic Intraocular Melanoma
  • Recurrent Intraocular Melanoma
  • Stage IV Intraocular Melanoma
  • Melanoma
  • Neoplasm Metastasis
  • Uveal Neoplasms
  • Liver Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195