Status:
TERMINATED
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Ocular Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Metastatic Ocular Melanoma
Metastatic Uveal Melanoma
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief Summary
Background: \- The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in...
Detailed Description
Background: * Metastatic ocular melanoma (OM) carries a poor prognosis with estimated survival of 4-6 months. There are no known effective systemic therapies. Metastatic OM is classified as an orphan...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Measurable metastatic ocular melanoma.
- Confirmation of diagnosis of metastatic ocular melanoma by the Laboratory of Pathology of the National Cancer Institute (NCI).
- Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
- Greater than or equal to 16 years of age and less than or equal to age 75.
- Able to understand and sign the Informed Consent Document
- Willing to sign a durable power of attorney
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Life expectancy of greater than three months
- Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment.
- Serology:
- Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
- Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative.
- Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.
- Hematology
- Absolute neutrophil count greater than 1000/mm\^3 without the support of filgrastim
- White blood cell (WBC) greater than or equal to 3000/mm\^3
- Platelet count greater than or equal 100,000/mm\^3
- Hemoglobin \> 8.0 g/dl
- Chemistry:
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to 3.5 times the upper limit of normal
- Serum creatinine less than or equal to 1.6 mg/dl
- Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
- More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).
- Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria.
- EXCLUSION CRITERIA:
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
- Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
- Concurrent systemic steroid therapy.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- The following patients will be excluded from the high-dose aldesleukin arm (but may be eligible for cells alone arm):
- History of coronary revascularization or ischemic symptoms
- Documented left ventricular ejection fraction (LVEF) of less than or equal to 45%. Testing is required in patients with:
- Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block
- Age greater than or equal to 60 years old
- Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patients ability to tolerate aldesleukin
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01814046
Start Date
March 1 2013
End Date
May 31 2017
Last Update
October 11 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892