Status:
COMPLETED
Natural Killer Cells Plus IL-2 Following Chemotherapy to Treat Advanced Melanoma or Kidney Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Metastatic Melanoma
Metastatic Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: * Natural killer (NK) cells are large lymphocytes (a type of white blood cell) that are important in the immune response to cancer. * IL-2 (Aldesleukin) is a substance the body makes that...
Detailed Description
Background: * Natural killer (NK) cells are large granular lymphocytes that are critical effector cells in the early innate immune response to pathogens and cancer. * Previous and current clinical in...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must have previously received high dose IL-2 (aldesleukin) and have been either non-responders (progressive disease) or have recurred.
- Patients who are greater than or equal to 18 years of age, must have measurable metastatic melanoma or metastatic kidney cancer and no tumor reactive T cells available for cell transfer therapy.
- Pathology for metastatic melanoma or metastatic kidney cancer to be confirmed by the National Cancer Institute (NCI) Laboratory of Pathology.
- Patients of both genders must be willing to practice birth control for four months after receiving the preparative regimen.
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1.
- Absolute neutrophil count greater than 1000/mm\^3.
- Platelet count greater than 100,000/mm\^3.
- Hemoglobin greater than 8.0 g/dl.
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than three 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.
- Must be willing to sign a durable power of attorney.
- EXCLUSION CRITERIA:
- Less than four weeks has elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, or less than six weeks since prior nitrosurea therapy.
- 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.
- Life expectancy of less than three months.
- Systemic steroid therapy required.
- Any active systemic infections, coagulation disorders or other 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 autoimmune disease (such as autoimmune colitis or Crohn's Disease).
- Seropositive 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.)
- Seropositive for hepatitis B or C antigen.
- Seronegative for Epstein-Barr virus (EBV).
- Patients who are not eligible to receive high-dose Aldesleukin as evaluated by the following:
- Patients who are 50 years old or greater who do not have a normal stress cardiac test (stress thallium, stress multi-gated acquisition scan (MUGA), dobutamine echocardiogram, or other stress test) will be excluded.
- Patients who have history of electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia or arrhythmias who do not have a normal stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) will be excluded.
- Patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction who do not have a normal pulmonary function test as evidenced by a forced expiratory volume 1 (FEV1) less than 60% predicted will be excluded.
- Patients who experienced toxicities during prior IL-2 administration that would preclude redosing with IL-2, i.e. myocardial infarction, mental status changes requiring intubation, bowel perforation or renal failure requiring dialysis.
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00328861
Start Date
May 1 2006
End Date
April 1 2009
Last Update
November 5 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892