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CAR T-cell Therapy
Modified White Blood Cells for Cancer
Phase 2
Waitlist Available
Led By Steven A Rosenberg, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Cohort 4: Patients must have Karnofsky performance status of greater than or equal to 60
- Patients with breast and ovarian cancer must be refractory to first-line treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-4 years post cell infusion
Awards & highlights
Study Summary
This trial is testing whether modified white blood cells can cause solid tumors to shrink. It is for people with certain types of cancer that has spread.
Who is the study for?
Adults aged 18-70 with certain advanced cancers (gastrointestinal, genitourinary, ovarian, breast, lung or glioblastoma) that have spread and are not responding to standard treatments. Participants must be in good health otherwise, with proper organ function and no severe infections or immune deficiencies. They should not be pregnant or breastfeeding and must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing a new therapy where patients' white blood cells are genetically modified to attack their tumors. This involves receiving the modified cells back into their body along with chemotherapy drugs Cyclophosphamide and Fludarabine, as well as Aldesleukin to boost the immune system.See study design
What are the potential side effects?
Possible side effects include reactions from the infusion of cells or drugs like fever and chills; low blood counts leading to increased infection risk; nausea; fatigue; liver enzyme changes; heart complications; allergic reactions to medications used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
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My breast or ovarian cancer did not respond to initial treatments.
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I have lung cancer and have been treated with both platinum-based chemotherapy and an FDA-approved targeted therapy.
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My advanced cancer did not respond to or has returned after standard treatment.
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I am between 18 and 70 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have colorectal cancer and have been treated with oxaliplatin or irinotecan.
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My white blood cell count is healthy without needing medication.
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My cancer is either in my stomach, gut, urinary system, breast, ovaries, lungs, or brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-4 years post cell infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-4 years post cell infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Immune monitoring
Phenotypic and functional characteristics of PBL
Safety and tolerance
Side effects data
From 2010 Phase 4 trial • 26 Patients • NCT0041476529%
Atrial fibrillation
14%
Oliguria
14%
Sepsis
14%
International normalised ratio increased
14%
Renal failure
14%
Mental status changes
14%
Chronic obstructive pulmonary disease
14%
Dyspnoea
14%
Respiratory failure
14%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
mRCC
Metastatic Melanoma
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/Sleeping BeautyExperimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + Sleeping Beauty Transposed PBL + high- or low-dose aldesleukin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Aldesleukin
2012
Completed Phase 4
~1620
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,667 Total Patients Enrolled
Steven A Rosenberg, M.D.Principal InvestigatorNational Cancer Institute (NCI)
37 Previous Clinical Trials
17,881 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may need occasional help.My breast or ovarian cancer did not respond to initial treatments.I have a tumor that can be surgically removed for treatment, and another that can be measured.I am not on steroids, except if I have glioblastoma.I've had minor surgery or limited radiotherapy recently but have recovered.I am 65 years old or older.My advanced cancer did not respond to or has returned after standard treatment.I do not have any current infections that could weaken my immune system.I have a history of serious heart rhythm problems or chest pain.I have a primary immunodeficiency disorder.You are not currently taking any experimental drugs for other studies.I have lung cancer and have been treated with both platinum-based chemotherapy and an FDA-approved targeted therapy.My glioblastoma has worsened after radiotherapy or I declined standard treatment.I finished my cancer treatments at least 2-6 weeks ago and have recovered from side effects.I have had a significant stroke or brain bleeding not related to brain tumor surgery in the last 6 months.You have had a serious allergic reaction to cyclophosphamide, fludarabine, or aldesleukin in the past.I have breathing problems.I do not have active hepatitis B or C.It has been over 4 weeks since my last systemic therapy.I am between 18 and 70 years old.I had treatment for major lung blockage or bleeding over two weeks ago and have recovered.My hemoglobin level is above 8.0 g/dL, possibly after a transfusion.I have a major blockage or bleeding in my airways that can't be relieved.I am fully active or restricted in physically strenuous activity but can do light work.I have colorectal cancer and have been treated with oxaliplatin or irinotecan.I have had heart surgery or symptoms of reduced blood flow to my heart.I am not pregnant or breastfeeding.My white blood cell count is healthy without needing medication.I have smoked at least 20 packs of cigarettes a year for the past two years.I have up to 3 small, symptom-free brain tumors or had them treated/stable for a month.My cancer is either in my stomach, gut, urinary system, breast, ovaries, lungs, or brain.I do not have any active infections or serious illnesses that are not under control.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Sleeping Beauty
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Aldesleukin a danger to people's health?
"Because there is only data supporting safety and none for efficacy, our team at Power gave Aldesleukin a score of 2."
Answered by AI
Could I qualify to enroll in this experiment?
"This particular study is only seeking breast cancer patients that are between 18 and 70 years old. Out of the 210 total participants needed, recruitment is still ongoing."
Answered by AI
What are the conditions that Aldesleukin is most often used to improve?
"Aldesleukin is an effective treatment against leukemia, retinoblastoma, myelocytic, and acute multiple sclerosis."
Answered by AI
Is this study limited to a certain age group?
"In order to meet the requirements for this particular clinical trial, patients must be between 18-70 years old. There are 438 other studies available for people under 18 and 3502 for seniors that are 65+."
Answered by AI
Are we recruiting participants for this clinical trial at the moment?
"That is correct. The clinical trial was posted on 11/23/2022 and is currently looking for 210 participants from 1 locations, as indicated by the information available on clinicaltrials.gov."
Answered by AI
How many people can join this clinical trial at the most?
"That is right, the trial detailed on clinicaltrials.gov is still recruiting patients. The 210 participants will be coming from a single site and the posting date was November 23rd, 2020 with the most recent update being on November 17th, 2020."
Answered by AI
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