An Early Phase 1 interventional study of aldesleukin and denileukin diftitox in Kidney Cancer, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-22.
Sponsored by Northwestern University · Early Phase 1, Interventional, and Treatment
RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry tumor-killing substances directly to kidney cancer cells. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving denileukin diftitox together with interleukin-2 may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects of denileukin diftitox and interleukin-2 in treating patients with metastatic kidney cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, pilot study.
The first 3 patients enrolled in the study receive high-dose interleukin-2 (IL-2) IV over 15 minutes, 3 times daily, on days 1-5 and 15-19 and denileukin diftitox IV over 15-60 minutes once daily on days 8-10. If no dose-limiting toxicity occurs after receiving denileukin diftitox, subsequent patients are randomized to 1 of 2 treatment arms.
All patients may receive additional treatment with IL-2 alone in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 4 years.
PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 20 is below the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →Northwestern University is the lead sponsor of 1,398 studies on the registry; 201 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Documented histologically confirmed metastatic renal cell carcinoma
Disease must be measurable as defined by lesions that can be accurately measured in at least one dimension with longest diameter > 20 mm using conventional techniques or > 10 mm with spiral CT scan
The following are considered nonmeasurable lesions:
PATIENT CHARACTERISTICS:
Adequate pulmonary reserve
Pulmonary function tests (PFTs) must be performed within 42 days of IL-2 treatment
PRIOR CONCURRENT THERAPY:
6 mcg/kg Denileukin Diftitox administered IV/daily on days 8-10 of standard interleukin 2 dose course
Biological: aldesleukin · Biological: denileukin diftitox
9 mcg/kg Denileukin Diftitox administered IV/daily on days -4 to -2 of standard interleukin 2 dose course
Biological: aldesleukin · Biological: denileukin diftitox
9 mcg/kg Denileukin Diftitox administered IV/daily on days 8-10 of standard interleukin 2 dose course
Biological: aldesleukin · Biological: denileukin diftitox
The IL-2 is given as a 15-minute infusion through an intravenous catheter (I.V.), a small plastic tube that is put into your vein for the time you are receiving the study treatment. IL-2 is given through the I.V. once every 8 hours for 5 days (days 1-5). A second 5 day cycle of IL-2 will begin on the 15th day (days 15-19). This is one complete cycle (days 1-19) of IL-2 treatment
Also known as: IL-2, Interleukin-2, Proleukin
Denileukin diftitox will be administered once daily as a 15 to 60 minute infusion for 3 consecutive days.
Also known as: ONTAK (denileukin diftitox), DAB 389 IL-2
The primary objective is to assess for toxicity
To assess the toxicity
Time frame: After each cycle of therapy and 30 days after the last treatment.
The secondary objectives are to investigate differences in peak and duration of the expansion of CD4+, CD8+, CD4+CD 25+ and CD56+(dim and bright)CD25+ cells
To investigate differences in peak and duration.
Time frame: Follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 8 weeks.
To investigate the effects of denileukin diftitox in combination with IL-2 on plasma TGF-beta levels
To investigate the effects of denileukin diftitox
Time frame: Cohort 1: Denileukin diftitox dose of 6μg/kg/ Days 1, 2, 3, 4, and 5. Cohort 2 Denileukin diftitox dose of 9μg/kg given 4, 3, 2, and 1 days prior to 1st day of each cycle. Cohort 3: Denileukin diftitox dose of 9μg/kg given days 8 and 9.
To perform TGF-beta promoter and TGF-beta receptor genotyping prior to the start of treatment to search for variants that may be associated with tumor response to therapy.
To perform TGF-beta promoter and TGF-beta receptor genotyping
Time frame: Cohort 1: Plasma TGF-beta levels to be given on day. Cohort 2: plasma TGF-beta levels to be given at day 1. Cohort 3: plasma TGF-beta levels given on days 1 through 5.
Overall response rate and time to progression
Overall response rate will be assessed.
Time frame: CT scans and other pertinent studies will be performed at week 10 to assess response.
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Northwestern University