Kidney CancerPhase 1NCT00014131
Vaccine Therapy in Treating Patients With Kidney Cancer
A Phase 1 study testing Biological/Vaccine: therapeutic autologous dendritic cells. in people with Kidney Cancer, run by Lisata Therapeutics, Inc. at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Biological/Vaccine: therapeutic autologous dendritic cells.
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Dec 2009
- Phase
- Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma
- Stage III or IV disease involving invasions beyond Gerota's fascia, regional lymph node involvement, or distant metastases OR
- Recurrent disease involving lymph node metastases or soft tissue nodules
- Measurable disease by anatomic-based radiological tests (unless no evidence of disease as documented by prior surgery)
- Planned resection of tumor to establish an autologous tumor cell line
- No active CNS metastases such as brain metastases, spinal cord compression, or leptomeningeal disease
- Prior brain metastases or spinal cord compression allowed provided there is radiographic evidence of lack of progression and no requirement for pharmacologic doses of corticosteroids
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 4 months
Hematopoietic:
- Hematocrit greater than 25%
- Platelet count greater than 100,000/mm3
- No ongoing transfusion requirements
- No active blood clotting or bleeding diathesis
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- Albumin at least 3.0 g/dL
- No significant hepatic dysfunction
Renal:
- Creatinine no greater than 2.0 mg/dL
- No significant renal dysfunction
Cardiovascular:
- No underlying cardiac disease associated with New York Heart Association class III or IV heart function
- No unstable angina related to atherosclerotic cardiovascular disease
Other:
- No other malignancy within the past 5 years except carcinoma in situ, basal cell or localized squamous cell skin cancer, or localized prostate cancer
- No active infection
- No other active medical condition that could be eminently life threatening
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Other prior putative vaccines allowed
- Recovered from prior biologic therapy
- No concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36%
Chemotherapy:
- At least 3 weeks since prior chemotherapy and recovered
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No concurrent corticosteroids
Radiotherapy:
- At least 3 weeks since prior radiotherapy (including whole-brain radiotherapy) and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- Concurrent bisphosphonates allowed for patients with lytic bone metastases
- No concurrent digoxin or other medications designed to improve cardiac output
- No other concurrent anticancer therapy or investigational therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
Official title: Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer.
Read the detailed description
OBJECTIVES:
- Determine the safety of immunization with in vitro-treated autologous tumor cells and dendritic cells with sargramostim (GM-CSF) in patients with stage III or IV or recurrent renal cell cancer.
- Determine the frequency of conversion of delayed tumor hypersensitivity tests in these patients treated with this regimen.
- Determine the progression-free and overall survival of these patients treated with this regimen.
- Determine the objective tumor response rate in patients who still have measurable disease at the time they are treated with this regimen.
OUTLINE: Patients are stratified according to measurable disease at the time vaccine therapy is initiated (yes vs no).
Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic disease following harvest receive systemic therapy (biologic therapy and/or chemotherapy) during tumor cell line expansion. Over 2-4 months, the tumor cell line is expanded, treated with interferon gamma, and irradiated.
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). The PBMC are incubated over 7 days with sargramostim (GM-CSF) and interleukin-4 to produce dendritic cells (DC). The DC are incubated over 2-3 days with the irradiated tumor cells from the autologous tumor cell line for antigen loading of the DC.
Patients undergo delayed tumor hypersensitivity testing 1 week prior to vaccination and again at week 4. Patients receive vaccine therapy comprising autologous treated tumor cells and DC suspended in GM-CSF subcutaneously weekly for 3 weeks. Vaccine therapy continues monthly for 5 months in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 3 months for 4 years.
PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- Biological/Vaccine: therapeutic autologous dendritic cells.
- Keywords
- stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological/Vaccine: therapeutic autologous dendritic cells.Biological
Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
| Study group | Role | What they receive |
|---|---|---|
| Biological/Vaccine | Experimental | Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product. Receives: Biological: Biological/Vaccine: therapeutic autologous dendritic cells. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy
Measured: week 4 and month 6 during vaccine therapy
Tumor response (partial response or complete response) as measured by RECIST at months 2 or 3 and 6 during study treatment, and 6 months after study completion
Measured: months 2 or 3 and 6 during study treatment, and 6 months after study completion
Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Measured: months 2 or 3 and 6 during study treatment and every 6 months after study completion
Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Measured: months 2 or 3 and 6 during study treatment and every 6 months after study completion
Overall survival beginning at the date of study entry
Measured: 5 years or until death, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 2001
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: change in corporate priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisata Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert O. Dillman, MD, FACP, Study chair, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014131
- Sponsor's protocol ID
- CDR0000068493
- Other IDs
- HOAG-VACCINE-RN, NCI-V01-1647
- Status last verified
- Oct 2023
- First submitted
- 10 Apr 2001
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Biotherapy Of Cancer: Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00014131
- Acronym / sponsor ID
- CDR0000068493
- Conditions
- Kidney Cancer
- Keywords
- stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in corporate priorities
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Lisata Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer.
Detailed description
OBJECTIVES:
- Determine the safety of immunization with in vitro-treated autologous tumor cells and dendritic cells with sargramostim (GM-CSF) in patients with stage III or IV or recurrent renal cell cancer.
- Determine the frequency of conversion of delayed tumor hypersensitivity tests in these patients treated with this regimen.
- Determine the progression-free and overall survival of these patients treated with this regimen.
- Determine the objective tumor response rate in patients who still have measurable disease at the time they are treated with this regimen.
OUTLINE: Patients are stratified according to measurable disease at the time vaccine therapy is initiated (yes vs no).
Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic disease following harvest receive systemic therapy (biologic therapy and/or chemotherapy) during tumor cell line expansion. Over 2-4 months, the tumor cell line is expanded, treated with interferon gamma, and irradiated.
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). The PBMC are incubated over 7 days with sargramostim (GM-CSF) and interleukin-4 to produce dendritic cells (DC). The DC are incubated over 2-3 days with the irradiated tumor cells from the autologous tumor cell line for antigen loading of the DC.
Patients undergo delayed tumor hypersensitivity testing 1 week prior to vaccination and again at week 4. Patients receive vaccine therapy comprising autologous treated tumor cells and DC suspended in GM-CSF subcutaneously weekly for 3 weeks. Vaccine therapy continues monthly for 5 months in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 3 months for 4 years.
PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological/Vaccine | Experimental | Biological: Biological/Vaccine: therapeutic autologous dendritic cells.Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Biological/Vaccine: therapeutic autologous dendritic cells.Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product. | Biological | Biological/Vaccine |
Primary outcome
Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy
Time frame: week 4 and month 6 during vaccine therapy
Tumor response (partial response or complete response) as measured by RECIST at months 2 or 3 and 6 during study treatment, and 6 months after study completion
Time frame: months 2 or 3 and 6 during study treatment, and 6 months after study completion
Progression-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Time frame: months 2 or 3 and 6 during study treatment and every 6 months after study completion
Event-free survival as measured by RECIST at months 2 or 3 and 6 during study treatment and every 6 months after study completion
Time frame: months 2 or 3 and 6 during study treatment and every 6 months after study completion
Overall survival beginning at the date of study entry
Time frame: 5 years or until death, whichever came first.
Results and safety
The study was stopped early (reason given: change in corporate priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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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, FACP study chair
Hoag Memorial Hospital Presbyterian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biological/Vaccine: therapeutic autologous dendritic cells. in people with Kidney Cancer, run by Lisata Therapeutics, Inc. at 1 site 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?
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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (reason given: change in corporate priorities). 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?
Conversion of the delayed-type hypersensitivity (DTH) skin test as measured by metric skin ruler at week 4 and month 6 during vaccine therapy (time frame: week 4 and month 6 during vaccine therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2023.