Stage IV MelanomaPhase 3NCT01875653
Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
A Phase 3 study testing Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) and Autologous PBMCs in GM-CSF (MC) in people with Stage IV Melanoma and Stage III Melanoma, run by Lisata Therapeutics, Inc. at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Melanoma, Stage III Melanoma
- What is being tested?
- Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) and Autologous PBMCs in GM-CSF (MC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 18 sitesUnited States
- Study dates
- Oct 2014to Jan 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
- d. Adequate kidney function: creatinine less than or equal to 2.0 mg/dL.
- e. Negative pregnancy test for woman of childbearing potential and use of effective contraception (hormonal or barrier method of birth control) during therapy (women of childbearing potential and men).
- Extent of disease established within 4 weeks of randomization.
- a. History and Physical Exam by a licensed practitioner.
- b. Fludeoxyglucose(FDG)-based PET/CT or PET scan and CT scan.
- c. Brain MRI demonstrating no new untreated or uncontrolled metastases.
- Recovery from previous therapies.
- a. At least four weeks (28 days) must have elapsed since any prior systemic therapy at the time of the first dose (six weeks for anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), and any toxicities experienced must have recovered to a grade 1 or less (except for alopecia or vitiligo).
- b. More than three weeks (at least 22 days) since radiation therapy at the time of the first dose (7 days for single-dose stereotactic radiotherapy such as gamma knife) and recovery from acute toxicities. Patients treated with whole brain radiation must wait at least 22 days after completion of radiation and have radiographic confirmation of lack of progression before proceeding to randomization.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Aurora, Colorado, 80045
Study site
Baltimore, Maryland, 21237
Study site
Cincinnati, Ohio, 45219
Study site
Dallas, Texas, 75251
Study site
Easton, Pennsylvania, 18020
Study site
Goshen, Indiana, 46526
Study site
Hackensack, New Jersey, 07601
Study site
Irvine, California, 92612
Study site
Knoxville, Tennessee, 37996
Study site
La Jolla, California, 92093
Study site
Los Angeles, California, 90033
Study site
Louisville, Kentucky, 40506
Study site
Marrero, Louisiana, 70072
Study site
Newport Beach, California, 92625
Study site
Orange, California, 92868
Study site
Philadelphia, Pennsylvania, 19107
Study site
Philadelphia, Pennsylvania, 19111
Study site
Santa Monica, California, 90404
About this study
Official title: 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
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.
Read the detailed description
Learn more about this clinical trial at http://TheIntusStudy.com. Type or copy and paste http://TheIntusStudy.com in your browser window.
- Conditions
- Stage IV Melanoma, Stage III Melanoma
- Being tested
- Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC), Autologous PBMCs in GM-CSF (MC)
- Keywords
- metastatic melanoma, dendritic cells, immunotherapy, Granulocyte-Macrophage Colony Stimulating Factor, overall survival, autologous, peripheral blood mononuclear cells, treatment, phase 3, tumor cells
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)Biological
Also called DC-TC, MAC-VAC, Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells In GM-CSF, Melapuldencel-T
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
Autologous PBMCs in GM-CSF (MC)Biological
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
| Study group | Role | What they receive |
|---|---|---|
| Autologous PBMCs in GM-CSF (MC) | Active comparator | DOSE/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. Receives: Biological: Autologous PBMCs in GM-CSF (MC) |
| Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) | Experimental | DOSE/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. Receives: Biological: Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 months
Secondary outcomes (1)
Adverse Events as a Measure of Safety and Tolerability
- Adverse Events monitoring to assess safety and tolerability
- History \& physical examination, vital signs, clinical laboratory tests (safety), and other tests as clinically indicated adverse event monitoring to assess safety and toxicity
Measured: 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisata Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert O Dillman, MD, Study chair, Caladrius Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875653
- Sponsor's protocol ID
- CL-CA-P01
- Other IDs
- 2015-001984-38, 2015
- Status last verified
- May 2019
- First submitted
- 7 Jun 2013
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26837440
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01875653
- Acronym / sponsor ID
- CL-CA-P01
- Conditions
- Stage IV Melanoma, Stage III Melanoma
- Keywords
- metastatic melanoma, dendritic cells, immunotherapy, Granulocyte-Macrophage Colony Stimulating Factor, overall survival, autologous, peripheral blood mononuclear cells, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Lisata Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Learn more about this clinical trial at http://TheIntusStudy.com. Type or copy and paste http://TheIntusStudy.com in your browser window.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous PBMCs in GM-CSF (MC) | Active comparator | Biological: Autologous PBMCs in GM-CSF (MC)DOSE/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) | Experimental | Biological: Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)DOSE/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)Also: DC-TC, MAC-VAC, Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells In GM-CSF, Melapuldencel-TComparison 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 | Biological | Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) |
| Autologous PBMCs in GM-CSF (MC)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 | Biological | Autologous PBMCs in GM-CSF (MC) |
Primary outcome
Overall survival
Time frame: 52 months
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.
1 secondary outcome
Adverse Events as a Measure of Safety and Tolerability
Time frame: 52 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Derived from this study: PubMed 26837440Javed 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert O Dillman, MD study chair
Caladrius Biosciences
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC) and Autologous PBMCs in GM-CSF (MC) in people with Stage IV Melanoma and Stage III Melanoma, run by Lisata Therapeutics, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 52 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.