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Laboratory-Treated Autologous Lymphocytes and Aldesleukin After Cyclophosphamide and Fludarabine in Treating Patients With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT00863330
Recruitment Status : Terminated (administrative decision- PI retired and treating physician left the institution)
First Posted : March 18, 2009
Results First Posted : December 17, 2014
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Jackie Blundon, MS, CIP, Aurora Health Care

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma (Skin)
Intervention Biological: Tumor Infiltrating Lymphocytes (TIL)
Enrollment 14
Recruitment Details  
Pre-assignment Details 14 participants were enrolled. For those, 8 were screen failures and 6 started the study.
Arm/Group Title Determine Toxicity of Treatment Regimen.
Hide Arm/Group Description Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
Period Title: Overall Study
Started 6
Completed 0
Not Completed 6
Reason Not Completed
study terminated early due to administra             6
Arm/Group Title Determine Toxicity of Treatment Regimen.
Hide Arm/Group Description Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
18 or over Number Analyzed 6 participants
6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Primary Objective
Hide Description Determine the ability of autologous cells infused with minimal in vitro culture in conjunction with high dose interleukin -2 (IL-2) following non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma.
Time Frame 4-6 weeks after completion of TIL
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated for administrative reasons. complete data was not collected and no data analysis was completed
Arm/Group Title Determine Toxicity of Treatment Regimen.
Hide Arm/Group Description:
Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Determine Toxicity of Treatment Regimen.
Hide Arm/Group Description Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
All-Cause Mortality
Determine Toxicity of Treatment Regimen.
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Determine Toxicity of Treatment Regimen.
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Determine Toxicity of Treatment Regimen.
Affected / at Risk (%)
Total   0/6 (0.00%) 
Study was ended early, before substantial data could be collected, due to Investigators retiring/leaving the institution.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: IIR regulatory specialist
Organization: Aurora Health Care
Phone: 414-219-7886
Responsible Party: Jackie Blundon, MS, CIP, Aurora Health Care
ClinicalTrials.gov Identifier: NCT00863330     History of Changes
Other Study ID Numbers: CDR0000636885
STLMC-L-0839
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: December 3, 2014
Results First Posted: December 17, 2014
Last Update Posted: January 6, 2015