Ipilimumab With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Melanoma Mets Pts
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|ClinicalTrials.gov Identifier: NCT01701674|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2012
Results First Posted : May 2, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Ipilimumab Procedure: Tumor Infiltrating Lymphocytes (TIL) Drug: Administration of Lymphodepletion Drug: Cyclophosphamide as Part of Lymphodepletion Drug: Fludarabine as Part of Lymphodepletion Drug: High Dose IL-2 Biological: Adoptive Cell Therapy with TIL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Co-stimulation With Ipilimumab to Enhance Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Patients With Metastatic Melanoma|
|Actual Study Start Date :||October 3, 2012|
|Actual Primary Completion Date :||April 21, 2016|
|Estimated Study Completion Date :||February 2019|
Experimental: Combination Therapy
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
Pre-treatment with ipilimumab (cycle 1): Before the participant's tumor sample is taken to send to the lab for growing the TILs, they will start their first cycle of ipilimumab. This drug is given as an intravenous infusion (through a vein) over a period of about 90 minutes (an hour and a half). Cycle 2 of ipilimumab: About a week after the sample of the participant's tumor was collected for TIL growth (and 3 weeks after their first cycle of ipilimumab), participants will have their second cycle of ipilimumab. This will be another IV infusion, lasting about 90 minutes.
Other Name: YervoyProcedure: Tumor Infiltrating Lymphocytes (TIL)
Tumor sample for TIL growth in the lab: About 2 weeks after the participant's first cycle of ipilimumab, a sample of their tumor will be collected and sent to the lab for TIL growth. Growing the TILs takes about 6 weeks. If their sample has grown enough TIL cells, participants will continue with the next part of the study. Depending on how long the TILs take to grow in the lab, they may need to repeat some of their laboratory and imaging tests (blood draws, X-rays, and CT or magnetic resonance imaging [MRI] scans). TIL Infusion (inpatient): After completing lymphodepletion, participants will be admitted back into the hospital for IV infusion of the TIL cells.Drug: Administration of Lymphodepletion
Lymphodepletion (inpatient hospital stay for about 2 days plus outpatient drug dosing for 5 days): About 4 weeks after their second cycle of ipilimumab, participants will be admitted to the hospital for their first two days of receiving the chemotherapy drug, cyclophosphamide. This drug will be given as an intravenous (IV, meaning through the vein) infusion. After 2 days of receiving cyclophosphamide, if their study doctor thinks that they are well enough, you will be discharged from the hospital and will return for the next 5 days in a row for outpatient IV infusions of the second lymphodepletion chemotherapy, fludarabine.Drug: Cyclophosphamide as Part of Lymphodepletion
Other Name: CytoxanDrug: Fludarabine as Part of Lymphodepletion
Other Name: FludaraDrug: High Dose IL-2
High dose IL-2 (continued inpatient): Participants will remain in the hospital following TIL infusion for receiving high dose IL-2 and recovery. The IL-2 will be given three times per day for about 3-5 days as an IV bolus (meaning through the vein, more quickly than other infusions - in about 15 minutes each dose). Participants will remain in the hospital for approximately 7-14 days until they have recovered from the IL-2 treatments.
Other Names:Biological: Adoptive Cell Therapy with TIL
Other Name: ACT
- Occurrence of Dose Limiting Toxicity (DLT) Events [ Time Frame: 3 months ]Occurrence of adverse events with dose limiting toxicity, per adverse event category.
- Rate of Meeting Feasibility Requirements [ Time Frame: 3 months ]Number of participants who were successfully treated with at least 2 doses of ipilimumab and received TIL. Feasibility is defined as the ability to deliver at least 50% (i.e., two out of four) of the planned doses of ipilimumab and successfully treat at least 60% (i.e., ≥ 6/10) of the patients with TIL.
- Overall Response Rate (ORR) [ Time Frame: 3 months ]Overall response (OR) is defined as the participant being alive at week 6, confirmed at week 12 and tumor size evaluated at both times using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be a complete response (CR) or partial response (PR). Evaluations will be made by computed tomography (CT) scan approximately 6 weeks after the cell infusion, then confirmed by CT scanning approximately 12 weeks after the cell infusion, and by clinical evaluation during the first 12 weeks. The overall response (CR+PR) rate will be summarized using both a point estimate and its exact confidence interval based on the binomial distribution.
- Progression Free Survival (PFS) [ Time Frame: 3 months ]Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Progressive Disease (PD): At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701674
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Amod Sarnaik, M.D.||H. Lee Moffitt Cancer Center and Research Institute|