Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
Phase III, Randomized, Double-Blind, Multicenter Trial of Autologous Dendritic Cells and Irradiated Autologous Tumor Cells In Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) vs. Autologous Peripheral Blood Mononuclear Cells (PBMCs) In GM-CSF for The Treatment Of Metastatic Melanoma
2 other identifiers
interventional
4
1 country
18
Brief Summary
The purpose of this research is to evaluate the safety and effectiveness of tumor cell therapy. This research study is evaluating if a patient-specific experimental therapy for metastatic melanoma will lengthen survival with minimal harmful effects. It is called an experimental therapy (or "study therapy") because it is not yet approved by the U.S. Food and Drug Administration (FDA). This research study will use the patient's own tumor cells,the patient's own dendritic cells (a type of immune cell), and a granulocyte-macrophage colony stimulating factor (GM-CSF, a type of growth factor). GM-CSF is a natural growth factor that stimulates growth of white blood cells in the body. Since 1991, GM-CSF has been used as a standard treatment to help increase the number of white blood cells after chemotherapy. The patient's dendritic cells are grown in a test-tube with the patient's tumor cells and the growth factor. The resulting solution is called the study therapy. The intent of the study therapy is to make the dendritic cells more effective at fighting the tumor when they are injected back into the patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2014
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedMay 10, 2019
May 1, 2019
1.3 years
June 7, 2013
May 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
The time frames are estimated time in months (rounded up to the nearest month) from the start of study. The time estimates for the analyses are based on enrolling approximately 250 patients over a 34.8 months period and having a follow up of approximately 17 months after the last patient is enrolled.
52 months
Secondary Outcomes (1)
Adverse Events as a Measure of Safety and Tolerability
52 months
Study Arms (2)
Autologous PBMCs in GM-CSF (MC)
ACTIVE COMPARATORDOSE/ROUTE/REGIMEN: 1. Treatment Duration: Doses of MC will be administered subcutaneously weekly for 3 consecutive weeks, then monthly for the next 5 months. 2. Dosage: Each dose of MC contains approximately 10 million cells. Each dose is suspended in 500 mcg GM-CSF prior to administration. 3. Mode of Administration: Subcutaneous (SC) injections.
Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)
EXPERIMENTALDOSE/ROUTE/REGIMEN: 1. Treatment Duration: Doses of DC-TC will be administered subcutaneously weekly for 3 consecutive weeks, then monthly for the next 5 months. 2. Dosage: Each dose of DC-TC contains approximately 10-20 million cells. Each dose is suspended in 500 mcg GM-CSF prior to administration. 3. Mode of Administration: Subcutaneous (SC) injections.
Interventions
Comparison of a cancer treatment containing patient specific irradiated tumor cells mixed with antigen presenting immune cells suspended in an immune system stimulant vs. a cancer treatment containing patient specific immune cells suspended in an immune system stimulant
Comparison of a cancer treatment containing patient specific irradiated tumor cells mixed with antigen presenting immune cells suspended in an immune system stimulant vs. a cancer treatment containing patient specific immune cells suspended in an immune system stimulant
Eligibility Criteria
You may qualify if:
- Pre-Treatment Phase: Tissue Procurement and Establishment of Tumor Cell Line
- Histologic diagnosis of invasive melanoma.
- Measurable metastatic melanoma with at least one lesion amenable to -resection Stage III: recurrent regional disease, including regional disease with no known primary.
- Stage IV: distant metastatic melanoma.
- Age 18 years and older.
- Sign the "Tissue Consent", the pre-Clinical Informed Consent for Melanoma Tissue Procurement and initiation of cell line effort granting Caladrius permission to cryopreserve the tumor and/or to initiate an autologous tumor cell line from excess tissue that has been removed during a medical procedure (e.g., surgically excised).
- Initiation of Autologous Tumor Cell Line. Caladrius must have received a viable melanoma tumor tissue specimen that has been obtained and processed according to company SOPs to ensure tissue viability. The cell line can be initiated with either a specimen of fresh tumor or tumor that has been previously cryopreserved.
- Treatment Phase
- Successful establishment of an autologous melanoma cell line by Caladrius.
- Patients with multiple depots of distant metastatic disease must have previously received at least one or more of the following standard treatments: interleukin 2 (IL-2), or ipilimumab, or vemurafenib (if tumor expresses the V600E mutation), or dacarbazine or temozolomide, if not mutated for the V600E mutation, and not felt to be medically appropriate for IL-2 or ipilimumab. These may have been given alone, or in combination with other agents.
- Medical fitness to undergo a leukapheresis, including peripheral venous access or access by central vein if necessary.
- Medical fitness for participation in a phase III clinical trial.
- a. ECOG performance status of 0 or 1.
- b. Adequate bone marrow function: absolute neutrophil count (ANC) greater than 1000/mm (3), hematocrit greater than 30%, platelet count greater than 100,000/mm (3), no ongoing transfusion requirements.
- c. Adequate hepatic function: total bilirubin less than 2.0 mg/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times the upper limit of normal (ULN), albumin greater than 3 g/dL.
- +9 more criteria
You may not qualify if:
- Pre-Treatment Phase: Tissue Procurement and Establishment of Tumor Cell Line
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- Lack of a metastatic melanoma lesion that can be resected.
- Treatment Phase
- Known positive for hepatitis B or C or HIV.
- Pregnant or lactating women.
- Underlying cardiac disease associated with known myocardial dysfunction, or active treatment with digoxin or other medications being given to treat heart failure, or unstable angina related to atherosclerotic cardiovascular disease.
- Diagnosis of any other invasive cancer that requires ongoing treatment or for which there is evidence of active disease.
- Active, unresolved infection and/or receiving concurrent treatment with parenteral antibiotics (patients are eligible after antibiotics have been discontinued for at least 7 days prior to first dose and evidence of infection has resolved).
- Other active medical condition that could be imminently life threatening, in the opinion of the investigator, including no active blood clotting or bleeding diathesis.
- New or uncontrolled brain metastases or leptomeningeal disease and/or taking pharmacological doses of corticosteroids. Brain metastases treated by gamma knife or stereotactic radiotherapy are considered controlled, unless patient requires pharmacologic doses of corticosteroids. It is recognized that tumor necrosis may be confused with tumor progression in interpretation of Brain MRI.
- Known autoimmune disease, immunodeficiency, or disease process that involves the use of immunosuppressive therapy.
- Taking other anticancer therapy.
- Received another investigational drug within 28 days of the first dose.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Irvine, California, 92612, United States
Unknown Facility
La Jolla, California, 92093, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Newport Beach, California, 92625, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Santa Monica, California, 90404, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Goshen, Indiana, 46526, United States
Unknown Facility
Louisville, Kentucky, 40506, United States
Unknown Facility
Marrero, Louisiana, 70072, United States
Unknown Facility
Baltimore, Maryland, 21237, United States
Unknown Facility
Hackensack, New Jersey, 07601, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Easton, Pennsylvania, 18020, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Philadelphia, Pennsylvania, 19111, United States
Unknown Facility
Knoxville, Tennessee, 37996, United States
Unknown Facility
Dallas, Texas, 75251, United States
Related Publications (1)
Javed A, Sato S, Sato T. Autologous melanoma cell vaccine using monocyte-derived dendritic cells (NBS20/eltrapuldencel-T). Future Oncol. 2016 Mar;12(6):751-62. doi: 10.2217/fon.16.13. Epub 2016 Feb 3.
PMID: 26837440DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert O Dillman, MD
Caladrius Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 12, 2013
Study Start
October 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
May 10, 2019
Record last verified: 2019-05