Metastatic Melanoma Clinical Trial
Official title:
A Pilot Study of the Administration of Young Tumor Infiltrating Lymphocytes Following a Non-Myeloablative Lymphocyte Depleting Chemotherapy Regimen in Metastatic Melanoma
Background:
- The NCI Surgery Branch has developed an experimental therapy that involves taking white
blood cells from patients' tumors, growing them in the laboratory in large numbers, and
then giving the cells back to the patient with aldesleukin (IL-2) a drug that keeps the
white blood cells active. These cells are called Tumor Infiltrating Lymphocytes, or TIL
and we have given this type of treatment to over 200 patients with melanoma.
- This study will use chemotherapy to prepare the immune system before this white blood
cell treatment. Our prior studies indicate that aldesleukin may not be required for
cell transfer.
Objectives:
- To see if chemotherapy and white blood cell therapy without aldesleukin is a safe and
effective treatment for metastatic melanoma.
Eligibility:
- Individuals at least 18 years of age and less than or equal to 70 years of age with
metastatic melanoma.
Design:
- Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and
undergo a history and physical examination, scans, x-rays, lab tests, and other tests
as needed.
- Surgery: If the patients meet all of the requirements for the study they will undergo
surgery to remove a tumor that can be used to grow the TIL product.
- Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood
cells. {Leukapheresis is a common procedure, which removes only the white blood cells
from the patient.}
- Treatment: Once their cells have grown, the patients will be admitted to the hospital
for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the
hospital for about 4 weeks for the treatment.
- Follow up: Patients will return to the clinic for a physical exam, review of side
effects, lab tests, and scans about every 1-3 months for the first year, and then every
6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up
to 2 days.
Status | Terminated |
Enrollment | 18 |
Est. completion date | June 2018 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
- INCLUSION CRITERIA: - Measurable metastatic melanoma with available autologous TIL. - 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 18 years of age and less than or equal to 70 years of age. - Able to understand and sign the Informed Consent Document - Clinical performance status of 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 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 RT-PCR and be HCV 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 - WBC greater than or equal to 3000/mm(3) - Platelet count greater than or equal to 100,000/mm(3) - Hemoglobin > 8.0 g/dl - Chemistry: - Serum ALT/AST less than or equal to to 2.5 times the upper limit of normal - Serum Creatinine less than or equal to to 1.6 mg/dl - Total bilirubin less than or equal to to 1.5 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. - Six weeks must have elapsed since any prior antibody therapy including anti-CTLA4 antibody therapy that could affect any anti-cancer immune response, at the time the patient receives the preparative regimen to allow antibody levels to decline. NOTE: patients who have previously received ipililumab and have documented GI toxicity must have a colonoscopy with normal colonic biopsies.) - Patients must be ineligible to receive IL-2 based on evidence that may include ischemic heart disease, or arrhythmias, or poor ventricular ejection fraction (< 50%), or respiratory compromise (FEV1 < 60%), or clinically significant patient history which in the judgment of the investigator would compromise the patient s ability to tolerate aldesleukin. 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. - 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. - Patients with a ventricular ejection fraction (less than or equal to 30%), or respiratory compromise (FEV1 less than or equal to 40%). |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Atkins MB, Lotze MT, Dutcher JP, Fisher RI, Weiss G, Margolin K, Abrams J, Sznol M, Parkinson D, Hawkins M, Paradise C, Kunkel L, Rosenberg SA. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999 Jul;17(7):2105-16. Review. — View Citation
Gogas HJ, Kirkwood JM, Sondak VK. Chemotherapy for metastatic melanoma: time for a change? Cancer. 2007 Feb 1;109(3):455-64. Review. — View Citation
Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. — View Citation
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---|---|---|---|---|
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