Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma
|ClinicalTrials.gov Identifier: NCT00945269|
Recruitment Status : Terminated (ONTAK has been pulled off the market for further testing. Subsequently, EISAI will no longer be supporting clinical trials that utilize this drug.)
First Posted : July 24, 2009
Last Update Posted : December 8, 2011
RATIONALE: White blood cells that have been treated in a laboratory may be able to kill tumor cells in patients with melanoma. Aldesleukin and denileukin diftitox may stimulate the white blood cells to kill melanoma cells. Giving therapeutic autologous lymphocyte therapy together with aldesleukin and denileukin diftitox may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving therapeutic autologous lymphocytes together with aldesleukin and denileukin diftitox and to see how well it works in treating patients with stage III-IV melanoma
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Melanoma Stage III Melanoma Stage IV Melanoma||Biological: therapeutic autologous lymphocytes Biological: aldesleukin Biological: denileukin diftitox Procedure: biopsy Other: immunohistochemistry staining method Other: laboratory biomarker analysis Genetic: polymerase chain reaction||Phase 1 Phase 2|
I. Assess the safety of cellular adoptive immunotherapy in melanoma patients using autologous CD8+ antigen-specific T-cell clones following CD25 lymphodepletion.
II. Determine the influence of CD25 lymphodepletion on the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell (CTL) clones.
I. Assess the anti-tumor efficacy of cellular adoptive immunotherapy in melanoma patients using autologous CD8+ antigen-specific T cell clones following CD25 lymphodepletion.
II. Evaluate the induction of T cells to non-targeted tumor-associated antigens (antigen-spreading) following adoptive transfer of CD8+ antigen-specific CTL and CD25 lymphodepletion.
OUTLINE: This is a phase I study followed by a phase II study.
Patients receive autologous T-cell intravenously (IV) over 30-60 minutes on days 0 and 28 and low-dose aldesleukin subcutaneously (SC) twice daily on days 0 to 13 and 28 to 41. Beginning 4-6 days before second T- cell infusion, patients receive denileukin diftitox IV over 30 minutes on days 1-3. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks, 8 weeks, and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study To Evaluate The Safety Of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following CD25 Lymphodepletion For Patients With Metastatic Melanoma|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Experimental: Treatment (cellular adoptive immunotherapy)
Patients receive autologous T-cell IV over 30-60 minutes on days 0 and 28 and low-dose aldesleukin SC twice daily on days 0 to 13 and 28 to 41. Beginning 4-6 days before second T-cell infusion, patients receive denileukin diftitox IV over 30 minutes on days 1-3.
Biological: therapeutic autologous lymphocytes
Other Names:Biological: aldesleukin
Other Names:Biological: denileukin diftitox
Other Names:Procedure: biopsy
Optional correlative studies
Other Name: biopsiesOther: immunohistochemistry staining method
Other Name: immunohistochemistryOther: laboratory biomarker analysis
Correlative studiesGenetic: polymerase chain reaction
Other Name: PCR
- In vivo survival of CD8+ transferred T-clones [ Time Frame: Days +0, 1, 3, 7, 14, 22, 28, 29, 31, 35, 42, 49, 56, 63, 70, 77, 84 ]The design of this trial using the first infusion of CD8 T cells administered alone as a baseline for each patient permits intra-patient analysis using paired samples with increased statistical power.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945269
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Sylvia Lee||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|