Melanoma Treatment With White Blood Cells That Destroy MART Expressing Tumor Cells (NCT01495572) | Clinical Trial Compass
TerminatedPhase 2
Melanoma Treatment With White Blood Cells That Destroy MART Expressing Tumor Cells
Stopped: Due to slow accrual, the investigator decided to close the study.
United States5 participantsStarted 2011-12
Plain-language summary
Background:
\- Some cancer treatments collect a patient s own blood cells to use as specialized cancer-fighting cells. Collected white blood cells known as PBL (peripheral blood lymphocytes) can use to isolate special cells that can fight tumors. Before treatment with PBL, chemotherapy is given to destroy existing white blood cells so that the new cells can survive and attack the tumors. After PBL treatment, aldesleukin is given to help the new cells grow. Researchers want to see if special white blood cells that recognize a specific protein that is present in melanoma cells (melanoma antigen recognized by T cells (MART)) can cause tumors to shrink. These white blood cells will be tested with and without aldesleukin.
Objectives:
* To test the safety and effectiveness of white blood cells that target MART in the treatment of melanoma.
* To test white blood cells that target MART with and without aldesleukin.
Eligibility:
\- Individuals at least 18 years of age who have melanoma that has not responded to standard treatments.
Design:
* Participants will be screened with a medical history and physical exam. Blood and urine samples will be taken. Imaging studies such as x-rays or magnetic resonance imaging scans will be performed.
* Participants will provide white blood cells through leukapheresis. Researchers will attempt to isolate white blood cells that recognize MART
* Seven days before the start of treatment, participants will have chemotherapy.
* After the last dose of chemotherapy, participants will receive the MART reactive PBL cells. Filgrastim doses will also be given to help white blood cell counts return to normal. Participants will have frequent blood tests.
* Participants who are able to have aldesleukin treatment will start within 24 hours after receiving the MART reactive PBL cells. Treatment will continue for up to 5 days.
* Participants may have an optional tumor or lymph node biopsy to study the effects of treatment.
* If the tumor continues to grow after MART PBL treatment, participants may have one more round of cell collection and treatment.
* Participants will have followup visits for up to 6 months after receiving the MART reactive PBL treatment.
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
. Measurable metastatic melanoma.
. Confirmation of diagnosis of metastatic melanoma and positivity for melanoma antigens recognized by T cells (MART) confirmed by the Laboratory of Pathology of the National Cancer Institute (NCI).
. Patients with 3 or less brain metastases are eligible. Note: If lesions are symptomatic or greater than or equal to 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
. Patients must be refractory to high dose aldesleukin treatment.
. MART-1:27-35 reactive peripheral blood lymphocytes derived from a leukapheresis.
. Human leukocyte antigens (HLA-A) 0201 positive.
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.
. Greater than or equal to 18 years of age and less than or equal to age 70.
. Both genders must be willing to practice birth control during treatment and for four months after receiving the preparative regimen.
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.
. Systemic steroid therapy required.
. Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
. 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.)
. History of severe immediate hypersensitivity reaction to any of the agents used in this study.
. The following patients will be excluded from the high-dose aldesleukin arm (but may be eligible for cells alone arm):
. History of coronary revascularization or ischemic symptoms