Status:
COMPLETED
Chemotherapy Followed by gp100 Lymphocytes and Aldesleukin to Treat Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Skin Cancer
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: This study uses a new experimental procedure for treating melanoma that uses the patient's own lymphocytes (type of white blood cell), which are specially selected to target and destroy t...
Detailed Description
Background: * Tumor infiltrating lymphocytes (TIL) transfer studies in patients with metastatic melanoma following lymphodepletion have resulted in 50% objective response rates with a 10-15% rate of ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Measurable metastatic melanoma. The diagnosis of metastatic melanoma and positivity for gp100 will be confirmed by the Laboratory of Pathology of the the National Cancer Institute (NCI).
- Patients must be refractory to high dose aldesleukin treatment if they are medically eligible to receive it. Patients with noncutaneous melanoma are not required to be refractory to high dose aldesleukin.
- gp100:154-162 reactive peripheral blood lymphocytes derived from a
- leukapheresis.
- HLA-A\*0201 positive.
- Greater than or equal to 18 years of age.
- Willing to practice birth control during treatment and for four months after receiving the preparative regimen.
- Life expectancy of greater than three months.
- Willing to sign a durable power of attorney.
- Able to understand and sign the Informed Consent Document.
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1 for the high dose aldesleukin cohort or ECOG 0, 1 or 2 for the low dose aldesleukin cohort.
- Hematology:
- Absolute neutrophil count greater than 1000/mm\^3 without support of filgrastim
- Normal white blood cell (WBC) (greater than 3000/mm\^3).
- Hemoglobin greater than 8.0 g/dl
- Platelet count greater than 100,000/mm\^3.
- 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 or hepatitis C.
- Chemistry:
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than less or equal to 2.5 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 mg/dl.
- Negative pregnancy test in women of child bearing potential because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
- 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). 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 in Section 2.1.1.
- Six weeks must have elapsed since prior cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) antibody therapy to allow antibody levels to decline.
- Patients who have previously received anti-CTLA4 antibody and experienced treatment must have a normal colonoscopy with normal colonic biopsies.
- EXCLUSION CRITERIA:
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- Systemic steroid therapy required.
- For patients receiving high dose IL-2 only: 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).
- 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.)
- 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 IL-2 arm (but will be eligible for the low-dose arm):
- History of coronary revascularization or ischemic symptoms
- Any patient known to have an left ventricular ejection fraction (LVEF) less than or equal to 45%.
- Documented LVEF of less than or equal to 45% tested 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
- Documented forced expiratory volume 1 (FEV1) less than or equal to 60% predicted tested in patients with:
- A prolonged history of cigarette smoking (20 pk/yrs of smoking)
- Symptoms of respiratory dysfunction
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00665470
Start Date
April 1 2008
End Date
April 1 2012
Last Update
October 19 2015
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892