Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small … (NCT01727076) | Clinical Trial Compass
CompletedPhase 1
Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small Cell Lung Cancer, or Squamous Cell Head and Neck Cancer
United States20 participantsStarted 2013-02-15
Plain-language summary
This phase I trial studies the side effects and best dose of recombinant interleukin-15 in treating patients with melanoma, kidney cancer, non-small cell lung cancer, or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Recombinant interleukin-(IL)15 is a biological product, a protein, made naturally in the body and when made in the laboratory may help stimulate the immune system in different ways and stop tumor cells from growing.
Who can participate
Age range
19 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:
* Patients must have histological or cytological confirmed malignancy in the following disease groups: melanoma, non-small cell lung carcinoma, renal cell carcinoma or squamous cell head and neck carcinoma, for which no standard effective or curative options are available
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Documented evidence of disease progression during 6 month period prior to the time of enrollment
* Prior therapy requirements:
* At least \>= 1 prior completed chemotherapy regimen including chemotherapy, biologic, immunologic or targeted therapy
* At least 4 weeks from last dose of prior chemotherapy with resolution of the acute toxic effects of the therapy
* At least 2 weeks from completion of prior radiation therapy
* At least 4 weeks from last dose of prior investigational therapy
* Not receiving any current anti-cancer therapy
* At least 4 weeks from last dose of interferon or IL-2 therapy
* At least 8 weeks from completion of antibody therapy with anti-checkpoint antibodies, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) and anti-programmed cell death 1 (PD1)
* At least 4 weeks from last dose of prior other biologic agents
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky \> 70%)
* Absolute lymphocytes \> 500/mcL
* Absolute neutrophil count \> 1,000/mcL
* Platelets \> 100,000/mcL
* Total bilirubin within normal institutional limits
* …
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.
What they're measuring
1
MTD defined as the next lower dose in which 1 or more patients experiences a dose limiting toxicity defined as grade 3 or 4 toxicity graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0