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NCT01174121 · ClinicalTrials.gov registry record · Phase 2
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
A Phase 2 study of Metastatic Colorectal Cancer and Metastatic Pancreatic Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 332
- Enrollment target
- 1
- Study location
NCT01174121 is a Phase 2 study of Metastatic Colorectal Cancer and Metastatic Pancreatic Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 332 participants, above the 179-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (85% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01174121, a Phase 2 study of Metastatic Colorectal Cancer and Metastatic Pancreatic Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 332 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian/endometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells. Objective: The purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to see if this treatment is safe. Eligibility: \- Adults age 18-72 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial cancer, or glioblastoma refractory to standard chemotherapy. Design: Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed. Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product. Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. (Leukapheresis is a common procedure, which removes only the white blood cells from the patient.) Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans a
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Aldesleukin
- DRUG Pembrolizumab (Keytruda)
- BIOLOGICAL Young TIL
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2010-08-26 |
| Est. Completion | 2029-12-27 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01174121
The ClinicalTrials.gov registry entry for NCT01174121 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 332 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 179-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (85% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01174121 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01174121 about?
NCT01174121 is a clinical study titled "Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer". Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we...
What is the current status of trial NCT01174121?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 332 participants. The study started on 2010-08-26. Estimated completion is 2029-12-27.
What conditions does trial NCT01174121 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Metastatic Breast Carcinoma, Metastatic Ovarian Cancer, Metastatic Endocrine Tumors/ Neuroendocrine Tumors.
What interventions are being tested in trial NCT01174121?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (DRUG), Pembrolizumab (Keytruda) (DRUG), Young TIL (BIOLOGICAL).
Who is sponsoring clinical trial NCT01174121?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01174121 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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