CD8+ Antigen-Specific T Cells, Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT02027935|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2014
Last Update Posted : May 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma Stage IV Cutaneous Melanoma AJCC v6 and v7||Biological: Aldesleukin Biological: Autologous CD8+ Melanoma Specific T Cells Drug: Cyclophosphamide Biological: Ipilimumab Other: Laboratory Biomarker Analysis||Phase 2|
I. Evaluate the safety and efficacy of adoptively transferred cytotoxic T-lymphocytes (CTL) targeting melanoma tumors combined with anti-CTLA4.
I. Evaluate the influence of anti-CTLA4 on the duration of in vivo persistence and anti-tumor efficacy achieved following adoptive transfer of antigen-specific CTL.
II. Evaluate the influence of anti-CTLA4 on the induction of T cells to non-targeted tumor-associated antigens (antigen-spreading) following adoptive transfer antigen-specific CTL, and the correlation of these responses with clinical outcome.
Beginning 48 to 72 hours prior to T cell infusion, patients receive cyclophosphamide intravenously (IV) over 30-60 minutes. Patients then receive autologous CD8+ melanoma-specific T cells IV over 30-60 minutes on day 0, aldesleukin subcutaneously (SC) twice daily (BID) on days 0-13 and ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells and Anti-CTLA4 for Patients With Metastatic Melanoma|
|Actual Study Start Date :||January 22, 2015|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||January 31, 2023|
Experimental: Treatment (T cells, chemo, aldesleukin, ipilimumab)
Beginning 48 to 72 hours prior to T cell infusion, patients receive cyclophosphamide IV over 30-60 minutes. Patients then receive autologous CD8+ melanoma-specific T cells IV over 30-60 minutes on day 0, aldesleukin SC BID on days 0-13 and ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity.
Biological: Autologous CD8+ Melanoma Specific T Cells
Other Name: Autologous Melanoma Specific Cytotoxic T Lymphocytes
Other: Laboratory Biomarker Analysis
- Overall response [ Time Frame: Up to 12 weeks ]Monitored using the Bayesian approach of Thall, Simon, Estey and the extension by Thall and Sung.
- Incidence of toxicity [ Time Frame: Up to 5 years ]Monitored using the Bayesian approach of Thall, Simon, Estey and the extension by Thall and Sung.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027935
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Adi Diab||M.D. Anderson Cancer Center|