Harvesting Cells for Experimental Cancer Treatments (NCT00068003) | Clinical Trial Compass
By InvitationNot Applicable
Harvesting Cells for Experimental Cancer Treatments
United States7,000 participantsStarted 2003-09-08
Plain-language summary
Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
Objective:
This study will collect white blood cells from normal volunteers and white blood cells and/or tumor cells, from patients who have been screened for and are eligible for a NCI Surgery Branch treatment protocol. The cells collected from normal volunteers will be used as growth factors for the cells during the period of laboratory growth. The cells and/or tumor from patients will be used to make the cell treatment product.
Eligibility:
Patients must be eligible for a NCI Surgery Branch Treatment Protocol
Normal Volunteers must meet the criteria for blood donation
Design
Both patients and normal Volunteers will undergo apheresis. Patients will then undergo further testing as required by the treatment protocol.
There is no required follow up for normal volunteers.
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.
* ELIGIBILITY CRITERIA FOR PATIENTS WITH A CURRENT DIAGNOSIS OF CANCER:
INCLUSION CRITERIA:
* Patients must have a form of cancer currently being studied in the NCI-SB.
* Patient is able to understand and willing to sign a written informed consent document.
* Age greater than or equal to 18 years.
* Clinical performance status of ECOG 0 or 1.
* Serology
* Seronegative for HIV antibody. (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities).
* Seronegative for hepatitis B surface antigen and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
* Lesions which will be harvested for the generation of TIL should be accessible via standard surgical or radiological techniques and be associated with acceptable morbidity.
EXCLUSION CRITERIA:
* Active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system.
* Patients who cannot give proper informed consent to the experimental therapy due to an active psychiatric disorder or inability to understand the nature of the proposed therapy and attendant risk.
* Women of child-bearing potential who are pregnant because of the potentially danger…
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
Generating anti-tumor patient lymphocytes ex vivo
Timeframe: Approximately 20 years
2
To conduct genomic, proteomic, and immunologic research studies
Timeframe: Approximately 20 years
3
To obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer