RECRUITING

Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes

Conditions

Melanoma Gene Therapy Adoptive T-Cell Transfer IL-2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma.

Official Title

Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes: A Phase 1b Study

Quick Facts

Study Start:2015-02

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02870244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must have a diagnosis of metastatic melanoma which is evaluable either clinically or radiologically. * Patients must be 18 years of age or older. * Patients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelines. * Patients must have a performance status (PS) of 0 or 1 ECOG PS scale. * Patients must have the ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time. * Patients melanoma must be positive for both tyrosinase and HLA-A2 pathologic review from FNA, core or excisional biopsy of lesion. * Cardiac ejection fraction greater than 50 percent as determined by screening echocardiogram. * Patients that have undergone treatment with anti-CTLA-4, Cytotoxic T-Lymphocyte Antigen 4, antibody must have at least 6 weeks from last dose of CTLA-4 antibody and evidence of tumor progression before they can be enrolled into this study. * Patients that have undergone treatment with anti-PD-1, Programmed Death Receptor 1, Blockade or anti-PD-L1 antibody must have at least 4 weeks from last dose of antibody and evidence of tumor progression before they can be treated in this study. * Patients with V600E mutations are eligible if they have failed an approved BRAF inhibitor or MEK inhibitor therapy or have refused treatment with an approved BRAF inhibitor or MEK inhibitor. * Patients treated with prior Interleukin-2 (IL-2) are eligible. * Sufficient cardiopulmonary reserve for IL-2 per institutional guidelines.	* Special classes of subjects such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable. * ECOG performance status of 2 or greater. * Patients with a history metastatic melanoma involving the brain will be excluded if they have active disease or have had active disease within the prior three months that was not controlled with surgery or radiotherapy. * Patients taking steroids for disease control or pain management * Patients must not be pregnant or nursing because of the potentially harmful effects of these agents on a developing fetus. Women or men of reproductive potential must have agreed to use an effective contraceptive method. * Patients whose BRAF V600 mutation status is unknown should undergo an attempt to determine this information, patients who have a BRAF V600 mutation and are responding to BRAF with or without MEK inhibitor therapy, or have a BRAF V600 mutation and have not been offered the option of receiving BRAF with or without MEK inhibitor therapy for the treatment of their melanoma are excluded. * No prior malignancy is allowed except for the following- adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years. * Patients that have undergone immunotherapy targeting tyrosinase. * Patients that have undergone immunotherapy in combination with non-myeloablative chemotherapy. * Any of the following abnormal laboratory values Absolute neutrophil count less than 1.5 x 10\^9/L Platelet count less than 100 x 10\^9/L Serum bilirubin greater than 1.5 x upper limit of normal ULN Serum ALT, AST greater than 2.5 x ULN Serum ALP greater than 2 x ULN Serum Albumin less than 2.5 g dL International Normalized Ratio, INR greater than 1.5 Serum creatinine calculated creatinine clearance by the method of Cockcroft and Gault, less than 50mL min. * Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics. * Any severe or poorly controlled systemic disease, for example hypertension, clinically significant cardiovascular, pulmonary, or metabolic disease, disorders of wound-healing, ulcer or bone fracture. * Patients who have received any chemotherapy or investigational treatment within 4 weeks of study start. * Known infection with HIV, HBV, or HCV. * Known hypersensitivity to any of the components of the study drugs. * Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Inclusion Criteria

Exclusion Criteria

* Patients must have a diagnosis of metastatic melanoma which is evaluable either clinically or radiologically.
* Patients must be 18 years of age or older.
* Patients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelines.
* Patients must have a performance status (PS) of 0 or 1 ECOG PS scale.
* Patients must have the ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time.
* Patients melanoma must be positive for both tyrosinase and HLA-A2 pathologic review from FNA, core or excisional biopsy of lesion.
* Cardiac ejection fraction greater than 50 percent as determined by screening echocardiogram.
* Patients that have undergone treatment with anti-CTLA-4, Cytotoxic T-Lymphocyte Antigen 4, antibody must have at least 6 weeks from last dose of CTLA-4 antibody and evidence of tumor progression before they can be enrolled into this study.
* Patients that have undergone treatment with anti-PD-1, Programmed Death Receptor 1, Blockade or anti-PD-L1 antibody must have at least 4 weeks from last dose of antibody and evidence of tumor progression before they can be treated in this study.
* Patients with V600E mutations are eligible if they have failed an approved BRAF inhibitor or MEK inhibitor therapy or have refused treatment with an approved BRAF inhibitor or MEK inhibitor.
* Patients treated with prior Interleukin-2 (IL-2) are eligible.
* Sufficient cardiopulmonary reserve for IL-2 per institutional guidelines.

* Special classes of subjects such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable.
* ECOG performance status of 2 or greater.
* Patients with a history metastatic melanoma involving the brain will be excluded if they have active disease or have had active disease within the prior three months that was not controlled with surgery or radiotherapy.
* Patients taking steroids for disease control or pain management
* Patients must not be pregnant or nursing because of the potentially harmful effects of these agents on a developing fetus. Women or men of reproductive potential must have agreed to use an effective contraceptive method.
* Patients whose BRAF V600 mutation status is unknown should undergo an attempt to determine this information, patients who have a BRAF V600 mutation and are responding to BRAF with or without MEK inhibitor therapy, or have a BRAF V600 mutation and have not been offered the option of receiving BRAF with or without MEK inhibitor therapy for the treatment of their melanoma are excluded.
* No prior malignancy is allowed except for the following- adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years.
* Patients that have undergone immunotherapy targeting tyrosinase.
* Patients that have undergone immunotherapy in combination with non-myeloablative chemotherapy.
* Any of the following abnormal laboratory values Absolute neutrophil count less than 1.5 x 10\^9/L Platelet count less than 100 x 10\^9/L Serum bilirubin greater than 1.5 x upper limit of normal ULN Serum ALT, AST greater than 2.5 x ULN Serum ALP greater than 2 x ULN Serum Albumin less than 2.5 g dL International Normalized Ratio, INR greater than 1.5 Serum creatinine calculated creatinine clearance by the method of Cockcroft and Gault, less than 50mL min.
* Patients should not have any evidence of active or uncontrolled infection requiring treatment with antibiotics.
* Any severe or poorly controlled systemic disease, for example hypertension, clinically significant cardiovascular, pulmonary, or metabolic disease, disorders of wound-healing, ulcer or bone fracture.
* Patients who have received any chemotherapy or investigational treatment within 4 weeks of study start.
* Known infection with HIV, HBV, or HCV.
* Known hypersensitivity to any of the components of the study drugs.
* Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Contacts and Locations

Study Contact

Michael Nishimura, PhD

CONTACT

708-327-3241

mnishimura@lumc.edu

Ann Lau Clark, RN, MSN

CONTACT

708-327-3221

alausch@luc.edu

Principal Investigator

Michael Nishimura, PhD

PRINCIPAL_INVESTIGATOR

Loyola University

Study Locations (Sites)

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Collaborators and Investigators

Sponsor: Loyola University

Michael Nishimura, PhD, PRINCIPAL_INVESTIGATOR, Loyola University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-02

Study Completion Date2028-09

Study Record Updates

Study Start Date2015-02

Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

Melanoma
Gene Therapy
Adoptive T-Cell Transfer
IL-2

Additional Relevant MeSH Terms

Melanoma