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New treatment option for Melanoma
Official title Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
ClinicalTrials.gov ID: NCT02870244
What this study is testing
What is Escalating Doses?
Escalating Doses is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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...
- 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...
You likely can't join if
- Special classes of people such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be...
- 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...
- 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...
- Patients whose BRAF V600 mutation status is unknown should undergo an attempt to determine this information, patients who have a BRAF V600 mutation...
See the full eligibility 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...
- 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...
- 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 people 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Maywood, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maywood, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.