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T-cell Therapy

Aldesleukin for Melanoma

Phase 2
Waitlist Available
Led By Stephanie L Goff, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after cell infusion, then every 3 months x 3 and then every 6 months for 5 years, then per principal investigator (pi) discretion up to 5 years or disease progression
Awards & highlights

Study Summary

This trial is testing 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. This is to see if there is a difference in the response between patients who have received prior anti-PD1 treatment to those who have not received this prior ant-PD1 treatment.

Eligible Conditions
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after cell infusion, then every 3 months x 3 and then every 6 months for 5 years, then per principal investigator (pi) discretion up to 5 years or disease progression
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after cell infusion, then every 3 months x 3 and then every 6 months for 5 years, then per principal investigator (pi) discretion up to 5 years or disease progression for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P
Overall Response Rate (ORR)
Secondary outcome measures
Number of Treatment-related Adverse Events for Participants Who Received Pembrolizumab
Overall Progression Free Survival (PFS)
Overall Survival
+1 more
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Side effects data

From 2010 Phase 4 trial • 26 Patients • NCT00414765
29%
Atrial fibrillation
14%
Oliguria
14%
Sepsis
14%
Renal failure
14%
International normalised ratio increased
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

5Treatment groups
Experimental Treatment
Group I: Arm 2/Foll By Arm 1P-Low dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg AldesleukinExperimental Treatment4 Interventions
Decreased Chemo Prep Regimen+Retreat. Young TIL+High Dose Interleukin-2, Decreased Chemo Preparative Regimen. Young TIL+High Dose Interleukin-2, Standard Chemo (Retreat). Lower dose preparative regimen + Young TIL Cells. Aldesleukin: 720,000 IU/kg IV every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses). Fludarabine: 30 mg/kg/day intravenous piggy-back (IVPB) daily for 3 days. Cyclophosphamide: Days -5 to -3 (low-dose arm): Cyclophosphamide 300 mg/m^2 IV over 60 minutes. Young TIL: Day 0: Cells will be infused IV. Retreatment: Standard Chemo Prep Regimen. Aldesleukin: 720,000 IU/kg IV every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses). Fludarabine: 25 mg/m^2/day intravenous piggy-back (IVPB) daily for 5 days. Cyclophosphamide: 60 mg/kg/day X 2 days IV. Young TIL: Day 0: Cells will be infused IV.
Group II: Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg AldesleukinExperimental Treatment4 Interventions
Decreased Chemo Prep Regimen. Young Tumor Infiltrating Lymphocytes (TIL) Plus High Dose Interleukin-2 Lower Dose preparative regimen + Young Tumor Infiltrating Lymphocytes (TIL) Cells Aldesleukin: 720,000 IU/kg intravenous (IV) every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses). Fludarabine: 30 mg/kg/day intravenous piggy-back (IVPB) daily for 3 days Cyclophosphamide: Days -5 to -3 (low-dose arm): Cyclophosphamide 30 mg/kg IV over 60 minutes for 2 days. Young TIL: Day 0: Cells will be infused intravenously (IV)
Group III: Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg AldesleukinExperimental Treatment5 Interventions
Standard Chemo Prep Regimen(SCPR)+Retreat. Young TIL+High Dose(HD) Interleukin-2, SCPR. Young TIL+HD Interleukin-2, SC(Retreat). SCPR+Young TIL Cells retreatment with SCPR+Young TIL Cells+pembrolizumab. Aldesleukin:720,000 IU/kgIV every eight hours (+/-1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses). Fludarabine:25 mg/m^2/day intravenous piggy-back(IVPB) daily for 5 days. Cyclophosphamide:60 mg/kg/day X 2 days IV. Young TIL:Day 0: Cells will be infused IV. Retreatment with standard preparative regimen+Young TIL Cells+pembrolizumab. Aldesleukin:720,000 IU/kg IV every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses). Fludarabine:25 mg/m^2/day intravenous piggy-back (IVPB) daily for 5 days. Cyclophosphamide:60 mg/kg/day X 2 days IV. Young TIL: Day 0:Cells will be infused IV. Pembrolizumab:2 mg/kg IV on Days -2, 21 (+/- 2 days), 42 (+/- 2 days), and 63 (+/- 2 days).
Group IV: Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg AldesleukinExperimental Treatment4 Interventions
Standard Chemo Prep Regimen Young Tumor Infiltrating Lymphocytes (TIL) Plus High Dose Interleukin-2, Standard Chemo Preparative Regimen in participants previously treated with pembrolizumab or nivolumab. Standard preparative regimen + Young Tumor Infiltrating Lymphocytes (TIL) Cells Aldesleukin: 720,000 IU/kg intravenous (IV) every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses). Fludarabine: 25 mg/m^2/day intravenous piggy-back (IVPB) daily for 5 days Cyclophosphamide: 60 mg/kg/day X 2 days intravenous (IV) Young TIL: Day 0: Cells will be infused intravenously (IV)
Group V: Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg AldesleukinExperimental Treatment4 Interventions
Standard Chemo Prep Regimen. Young Tumor Infiltrating Lymphocytes (TIL) Plus High Dose Interleukin-2, Standard Chemo Preparative Regimen in participants without prior treatment pembrolizumab or nivolumab Standard preparative regimen + Young Tumor Infiltrating Lymphocytes (TIL) Cells Aldesleukin: 720,000 IU/kg intravenous (IV) every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses). Fludarabine: 25 mg/m^2/day intravenous piggy-back (IVPB) daily for 5 days Cyclophosphamide: 60 mg/kg/day X 2 days intravenous (IV) Young TIL: Day 0: Cells will be infused intravenously (IV)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1620
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780
Young TIL
2012
Completed Phase 2
~70
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,653 Previous Clinical Trials
40,932,528 Total Patients Enrolled
557 Trials studying Melanoma
193,200 Patients Enrolled for Melanoma
Stephanie L Goff, M.D.Principal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
98 Total Patients Enrolled
2 Trials studying Melanoma
98 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical OncologyJournal
Adoptive Cell Therapy for Patients with Metastatic Melanoma: Evaluation of Intensive Myeloablative Chemoradiation Preparative Regimens
Dudley, Mark E., James C. Yang, Richard Sherry, Marybeth S. Hughes, Richard Royal, Udai Kammula, Paul F. Robbins, et al.. 2008. “Adoptive Cell Therapy for Patients with Metastatic Melanoma: Evaluation of Intensive Myeloablative Chemoradiation Preparative Regimens”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2008.16.5449.
clinicaltrials.govStudy
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
Stephanie Goff 2013. "Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01993719.
~3 spots leftby Apr 2025
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