Mechanism of Action of High-Dose IL-2 (Aldesleukin) in Metastatic Melanoma and Kidney Cancer (NCT00304460) | Clinical Trial Compass
CompletedPhase 1
Mechanism of Action of High-Dose IL-2 (Aldesleukin) in Metastatic Melanoma and Kidney Cancer
United States138 participantsStarted 2006-03-13
Plain-language summary
Background:
-Although IL-2 can shrink tumors in about 20 percent of patients with metastatic kidney cancer and in 15 percent of patients with metastatic melanoma, it is not fully known how the drug works.
Objectives:
-To better understand how IL-2 causes tumors to shrink.
Eligibility:
-Patients 18 years of age or older with metastatic kidney cancer or metastatic melanoma
Design:
* 135 patients with melanoma and 110 patients with kidney cancer may be enrolled.
* Patients are hospitalized for about 7 days for each treatment. They receive IL-2 intravenously (through a vein) over 15 minutes every 8 hours for up to 4 days or 12 doses. This constitutes one treatment cycle.
* Research blood samples are collected daily during the first treatment cycle and for one or two days following the last dose.
* Patients may be asked to undergo leukapheresis, a procedure for collecting large quantities of white blood cells. This involves collecting blood through a needle in an arm vein. The blood is directed through a cell separator where the white cells are extracted. The rest of the blood (red cells, platelets, and plasma) is returned to the patient through the same needle or through a needle in the other arm.
* About 7-10 days after discharge from the hospital, patients return for a second treatment cycle but without research blood sampling.
* 2 months after therapy, patients are evaluated with scans, and x-rays, and blood tests to evaluate the tumor and the effects of the treatment on immune cells.
* Patients whose tumors shrink or remain stable may continue treatment (without repeating the full set of research blood samples) as long as they benefit from the treatment and do not develop unacceptable side effects. Patients who continue treatment are evaluated every 2 months for 3 to 4 times and then every 3 to 6 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Any patient with metastatic, measurable, histologically-proven RCC or melanoma who is a candidate for high-dose IL-2 therapy.
* Expected survival greater than three months.
* Age greater than or equal to18 years old.
* ECOG less than 2.
* Serum creatinine less than or equal to 1.4 mg/dl or creatinine clearance greater than or equal to 90 mL/min, and 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.
* Platelet count greater than 100,000/mm(3).
* Absolute neutrophil count greater than 1000/mm(3).
* Serum ALT/AST less than three times the upper limit of normal.
* Must be willing to sign a durable power of attorney.
* Must be willing to practice effective contraception (regardless of gender).
* Must be willing to sign the informed consent document.
EXCLUSION CRITERIA:
* Significant second malignancy within 3 years of protocol entry or likely to require intervention in the year following protocol entry.
* Significant psychiatric disease which in the opinion of the Principal Investigator would prevent adequate informed consent or render immunotherapy unsafe or contraindicated.
* Requirement for systemic or inhaled steroid administration (topical therapy is acceptable).
* Prior therapy within 28 days (except focal radiation for bone lesion).
* Systemic infections, coagulation disorders or evidence of active bleeding, or other major medical illnesses of the cardiov…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.