A Phase 1 interventional study of IL-2 (interleukin-2) and OKT3 in Kidney Neoplasms, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-26.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
Background:
Objectives:
-To determine whether special tumor-fighting cells taken from the patient's blood or tumor and grown in the laboratory can cause tumors in patients with kidney cancer to shrink when they are given back to the patient along with interleukin-2.
Eligibility: Patients 18 years of age or older with advanced kidney cancer.
Design:
Background:
One area of therapeutic advancement in immunotherapy has been to identify autologous tumor-reactive T-cells and expand them in vitro, and administer them in adoptive transfer back to patients. These T-cells have been obtained either from tumor infiltrating lymphocytes (TIL) which appear enriched for tumor-reactive T-cells or by in vitro stimulation of peripheral blood T-cells from cancer patients. Recent success in patients with melanoma has in large part been due to a T-cell expansion protocol described by Riddell et al. using anti-CD3 (cluster of differentiation 3) and irradiated allogeneic feeder cells and the use of conditioning chemotherapy prior to cell transfer. This current study uses the results of these Surgery Branch adoptive cell therapy trials to study their potential in patients with metastatic renal cell cancer.
Objectives:
The primary objective will be to determine whether adoptive lymphocyte transfer in conjunction with preparative lympho-depletion chemotherapy and interleukin-2 (IL-2) may result in clinical tumor regression in patients with metastatic renal cancer.
Eligibility:
Patients with metastatic renal cell cancer who have failed conventional therapy with interleukin-2, from whom tumor-reactive lymphocytes (from either peripheral blood, lymph nodes or tumor-infiltrating lymphocytes) can be obtained and expanded in vitro.
Patients must meet specific safety laboratory criteria, be able to tolerate interleukin 2 (IL-2), and have no concurrent major medical illnesses or symptomatic brain metastases.
Design:
All patients will receive a non-myeloablative lymphocyte depleting preparative regimen of cyclophosphamide (60 mg/kg/day intravenous (IV)) on days -7 and -6 and fludarabine (25 mg/m\^2/day intravenous (IV)) on days -5 through -1. On day 0 patients will receive an infusion of their own tumor-reactive T cells grown in vitro (greater than or equal to 5x10\^8 cells for a cycle) and then begin high-dose IL-2 (720,000 IU/kg intravenous (IV) every 8 hours for up to 15 doses).
Clinical and Immunologic response will be evaluated about 3 to 5 weeks after the treatment regimen.
This trial will be conducted as a phase II trial using a two-stage MinMax design which will try to determine whether intravenous (IV) cell administration can produce a modest response rate targeted to be greater than or equal to 35 % (p1=0.35) as opposed to an undesirably low response rate of less than 15% (p0=0.15). If at least 3 patients of 15 have an objective response (partial response (PR) or complete response (CR)) accrual will proceed to 28 patients, with a projected accrual over three years.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 3 is below the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA: CELL HARVEST:
-Active systemic infections, coagulation disorders, contra-indications to receiving interleukin-2 (IL-2) or major medical illnesses of the cardiovascular, respiratory or immune system.
INCLUSION CRITERIA: CELL INFUSION:
EXCLUSION CRITERIA: CELL INFUSION:
Determine whether Adoptive Lymphocyte Transfer in Conjunction with Preparative Lympho-depletion Chemotherapy and Interleukin-2 (IL-2) May result in Clinical Tumor Regression in Metastatic Renal Cancer
This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)