SarcomaPhase 2NCT00405327
A Pilot Study of Tumor Cell Vaccine for High-risk Solid Tumor Patients Following Stem Cell Transplantation
A Phase 2 study testing Tumor lysate-pulsed dendritic cell (DC) vaccine and Hematopoietic stem cell transplantation (HSCT) in people with Sarcoma and Neuroblastoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Localized solid tumors such as, sarcoma, neuroblastoma, and Wilms' tumor, can generally be effectively treated with a combination of surgery, radiation and chemotherapy. However, patients with metastatic or relapsed disease have a very poor prognosis. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Sarcoma, Neuroblastoma, Wilm's Tumor
- What is being tested?
- Tumor lysate-pulsed dendritic cell (DC) vaccine and Hematopoietic stem cell transplantation (HSCT)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2010
- Phase
- Phase 2
- 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- To participate in this study, it is necessary to collect sufficient tumor and peripheral blood stem cells to both develop the vaccine and perform the autologous stem cell transplant. Patients who also have previously had tumor or stem cells collected, which are available and sufficient for this study, are eligible to participate as study subjects.
- Patients must have a histologically verified diagnosis of neuroblastoma, Wilm's tumor, or sarcoma, including rhabdomyosarcoma, a Ewing's sarcoma family tumor (ES, PNET), synovial sarcoma, fibrosarcoma, or desmoplastic round cell tumor.
- and must meet one of the following criteria:
- have metastatic disease at diagnosis
- have never achieved complete remission following frontline standard therapy
- have relapsed after receiving standard therapy
Show all 24Show fewer
- Patients must have been < 30 years of age at the time of original diagnosis.
- Patients must have a source of tumor tissue from which approximately 1 gram of viable tumor can be obtained for vaccine development.
- Patients must have a good performance status (>70% by Lansky or Karnofsky scales).
- Patients must have a life expectancy of at least 16 weeks.
- Females of child-bearing age (>= 12 years old) must have a negative pregnancy test.
- Patients may enroll on this study at various points in their treatment including diagnosis, recurrence, or just prior to initiation of study mandated transplant therapy. Because patients may enter this study prior to completion of retransplant treatments, the below criteria must be met only to proceed to the high dose chemotherapy and autologous stem cell transplant part of this study. These criteria are not a requirement to enter this study in order to collect tumor or peripheral blood stem cells.
- Patients must have achieved complete response or very good partial response(>= 90% decrease in tumor volume) before proceeding to transplant. For patients enrolling on this study just prior to transplant a VGPR or CR must be achieved to be eligible.
- Patients may have undergone prior autologous peripheral blood stem cell transplantation, provided at least 12 months have elapsed prior to entry on this study.
- Patients must have had a successful peripheral blood stem cell collection, with cryopreservation of PBSCs for both engraftment and for generation of dendritic cells.
- Adequate baseline organ function must be present:
- hematologic parameters (not applicable if bone marrow is involved with tumor):
- ANC > 500/mm3
- platelet count > 50,000/mm3
- serum creatinine < 1.5x upper limit of normal for age
- serum hepatic transaminases (AST, ALT) < 3x upper limit of normal
- serum bilirubin < 1.5x upper limit of normal
- cardiac echocardiogram with either SF > 27% or EF > 50%. A comparable EF on a MUGA scan will also meet eligibility criteria.
- Give or obtain informed consent
Who cannot join
- Patients who have received prior antitumor vaccines are ineligible
- Patients who meet the response criteria but progress prior to study enrollment are ineligible
- Patients with known autoimmune diseases or conditions are ineligible
- Patients with HIV infection, AIDS, hepatitis B surface antigen positivity, ongoing bleeding, or any significant uncontrolled medical or psychiatric illness are ineligible.
- Patients under treatment for infection must cleared by BMT physician prior to enrollment.
- Patients who are pregnant or nursing are ineligible
- Prior allogenic transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan, Department of Surgery, Pediatric Section
Ann Arbor, Michigan, 48170
About this study
Official title: A Pilot Study of Tumor Lysate-pulsed Dendritic Cell Vaccine for Immune Augmentation for High-risk Solid Tumor Patients Following Autologous Stem Cell Transplantation
Localized solid tumors such as, sarcoma, neuroblastoma, and Wilms' tumor, can generally be effectively treated with a combination of surgery, radiation and chemotherapy. However, patients with metastatic or relapsed disease have a very poor prognosis.
New approaches to the management of these difficult groups of patients are needed. There is evidence to suggest that solid tumors may be good candidates for immunotherapy approaches. In fact, recent experimental evidence indicates that the period of lymphopenia that occurs after stem cell transplant may be an opportune time to use an immunotherapy treatment approach. In light of the very poor prognosis of young patients with advanced solid tumors, this treatment approach warrants further investigation.
Read the detailed description
Localized solid tumors such as, sarcoma, neuroblastoma, and Wilms' tumor, can generally be effectively treated with a combination of surgery, radiation and chemotherapy. However, patients with metastatic or relapsed disease have a very poor prognosis.
For the past decade, efforts to increase overall survival and progression-free survival for patients with high-risk pediatric and young adult tumors, have evaluated the use of high-dose chemotherapy and hematopoietic stem cell transplantation (HSCT). The proportion of patients who enter a complete remission with HSCT is high, ranging from 81 to 90%. While autologous HSCT renders a large proportion of patients temporarily disease-free, relapse develops in the majority of patients.
Survival appears to have been most improved with this strategy for neuroblastoma, but relapses occur in the majority of patients. Similar strategies have also been tried for patients with advanced stage sarcoma and Wilms' tumor, but relapses are even more problematic.
New approaches to the management of these difficult groups of patients are needed. There is evidence to suggest that solid tumors may be good candidates for immunotherapy approaches. In fact, recent experimental evidence indicates that the period of lymphopenia that occurs after HSCT may be an opportune time to use this treatment approach. In light of the very poor prognosis of young patients with advanced solid tumors, this treatment approach warrants further investigation.
- Conditions
- Sarcoma, Neuroblastoma, Wilm's Tumor
- Being tested
- Tumor lysate-pulsed dendritic cell (DC) vaccine, Hematopoietic stem cell transplantation (HSCT)
- Keywords
- tumor vaccine, metastatic solid tumors, recurrent tumors
- Medical subject headings
- Sarcoma, Neuroblastoma, Wilms Tumor, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor lysate-pulsed dendritic cell (DC) vaccineBiological
Tumor lysate-pulsed dendritic cell vaccine
Hematopoietic stem cell transplantation (HSCT)Other
Hematopoietic stem cell transplantation (HSCT)
| Study group | Role | What they receive |
|---|---|---|
| DC vaccine therapy | Experimental | Tumor lysate-pulsed dendritic cell (DC) vaccine following HSCT Receives: Biological: Tumor lysate-pulsed dendritic cell (DC) vaccine; Other: Hematopoietic stem cell transplantation (HSCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the rate of immune response of this immunotherapy treatment
Measured: 70 days
Secondary outcomes (2)
To correlate and characterize the immune response to the clinical response.
Measured: three years
To define immunologic endpoints that can serve as surrogates of clinical response.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Geiger, MD, University of Michigan Rogel Cancer Center
- Investigators
- James D Geiger, M.D., Principal investigator, University of Michigan, Department of Surgery, Pediatric Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405327
- Sponsor's protocol ID
- UMCC 2005.050
- Other IDs
- GCRC ID # 2191, HUM00002650
- Status last verified
- Nov 2017
- First submitted
- 29 Nov 2006
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Tumor Lysate-pulsed Dendritic Cell Vaccine for Immune Augmentation for High-risk Solid Tumor Patients Following Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00405327
- Acronym / sponsor ID
- UMCC 2005.050
- Conditions
- Sarcoma, Neuroblastoma, Wilm's Tumor
- Keywords
- tumor vaccine, metastatic solid tumors, recurrent tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Nov 2006 (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.
Localized solid tumors such as, sarcoma, neuroblastoma, and Wilms' tumor, can generally be effectively treated with a combination of surgery, radiation and chemotherapy. However, patients with metastatic or relapsed disease have a very poor prognosis.
New approaches to the management of these difficult groups of patients are needed. There is evidence to suggest that solid tumors may be good candidates for immunotherapy approaches. In fact, recent experimental evidence indicates that the period of lymphopenia that occurs after stem cell transplant may be an opportune time to use an immunotherapy treatment approach. In light of the very poor prognosis of young patients with advanced solid tumors, this treatment approach warrants further investigation.
Detailed description
Localized solid tumors such as, sarcoma, neuroblastoma, and Wilms' tumor, can generally be effectively treated with a combination of surgery, radiation and chemotherapy. However, patients with metastatic or relapsed disease have a very poor prognosis.
For the past decade, efforts to increase overall survival and progression-free survival for patients with high-risk pediatric and young adult tumors, have evaluated the use of high-dose chemotherapy and hematopoietic stem cell transplantation (HSCT). The proportion of patients who enter a complete remission with HSCT is high, ranging from 81 to 90%. While autologous HSCT renders a large proportion of patients temporarily disease-free, relapse develops in the majority of patients.
Survival appears to have been most improved with this strategy for neuroblastoma, but relapses occur in the majority of patients. Similar strategies have also been tried for patients with advanced stage sarcoma and Wilms' tumor, but relapses are even more problematic.
New approaches to the management of these difficult groups of patients are needed. There is evidence to suggest that solid tumors may be good candidates for immunotherapy approaches. In fact, recent experimental evidence indicates that the period of lymphopenia that occurs after HSCT may be an opportune time to use this treatment approach. In light of the very poor prognosis of young patients with advanced solid tumors, this treatment approach warrants further investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC vaccine therapy | Experimental | Biological: Tumor lysate-pulsed dendritic cell (DC) vaccine, Other: Hematopoietic stem cell transplantation (HSCT)Tumor lysate-pulsed dendritic cell (DC) vaccine following HSCT |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (24 listed)
- To participate in this study, it is necessary to collect sufficient tumor and peripheral blood stem cells to both develop the vaccine and perform the autologous stem cell transplant. Patients who also have previously had tumor or stem cells collected, which are available and sufficient for this study, are eligible to participate as study subjects.
- Patients must have a histologically verified diagnosis of neuroblastoma, Wilm's tumor, or sarcoma, including rhabdomyosarcoma, a Ewing's sarcoma family tumor (ES, PNET), synovial sarcoma, fibrosarcoma, or desmoplastic round cell tumor.
- Patients must have been < 30 years of age at the time of original diagnosis.
- Patients must have a source of tumor tissue from which approximately 1 gram of viable tumor can be obtained for vaccine development.
- Patients must have a good performance status (>70% by Lansky or Karnofsky scales).
Key exclusion criteria (7 listed)
- Patients who have received prior antitumor vaccines are ineligible
- Patients who meet the response criteria but progress prior to study enrollment are ineligible
- Patients with known autoimmune diseases or conditions are ineligible
- Patients with HIV infection, AIDS, hepatitis B surface antigen positivity, ongoing bleeding, or any significant uncontrolled medical or psychiatric illness are ineligible.
- Patients under treatment for infection must cleared by BMT physician prior to enrollment.
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 |
|---|---|---|
| Tumor lysate-pulsed dendritic cell (DC) vaccineTumor lysate-pulsed dendritic cell vaccine | Biological | DC vaccine therapy |
| Hematopoietic stem cell transplantation (HSCT)Hematopoietic stem cell transplantation (HSCT) | Other | DC vaccine therapy |
Primary outcome
To estimate the rate of immune response of this immunotherapy treatment
Time frame: 70 days
2 secondary outcomes
To correlate and characterize the immune response to the clinical response.
Time frame: three years
To define immunologic endpoints that can serve as surrogates of clinical response.
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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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.
James D Geiger, M.D. principal investigator
University of Michigan, Department of Surgery, Pediatric Section
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tumor lysate-pulsed dendritic cell (DC) vaccine and Hematopoietic stem cell transplantation (HSCT) in people with Sarcoma and Neuroblastoma, run by University of Michigan Rogel Cancer Center 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?
The sponsor lists 24 inclusion and 7 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: finished, as of the sponsor's last update on 6 Nov 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To estimate the rate of immune response of this immunotherapy treatment (time frame: 70 days). 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 6 Nov 2017.