Sarcoma, Clear CellPhase 1NCT00258687
Vaccine Trial for Clear Cell Sarcoma, Pediatric Renal Cell Carcinoma, Alveolar Soft Part Sarcoma and Children With Stage IV Melanoma
A Phase 1 study testing GVAX in people with Sarcoma, Clear Cell and Sarcoma, Alveolar Soft Part, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to learn if a vaccine made from the patient's own tumor cells, then genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), will delay or stop the growth of the tumor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma, Clear Cell, Sarcoma, Alveolar Soft Part, Renal Cell Carcinoma
- What is being tested?
- GVAX
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ECOG performance status 0 or 1
- Estimated life expectancy of greater than 6 months
- Greater than or equal to 4 weeks from chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy
- Greater than or equal to 6 months from prior bone marrow or peripheral blood stem cell (PBSC) transplant
- Histologically confirmed alveolar soft part sarcoma or clear cell sarcoma at any age.
- Evidence of metastatic disease, including having spread either to distant sites that may include brain metastases, or to regional lymph nodes alone, or locally advanced primary lesion that is not fully surgically resectable at study entry.
Show all 9Show fewer
- Histologically confirmed Stage IV renal cell carcinoma (patients with brain metastases still eligible)
- Any patients with Stage IV renal cell carcinoma under the age of 25 years who do not have a renal cell carcinoma predisposition syndrome
- Patients with Stage IV melanoma and under the age of 18 years
Who cannot join
- Uncontrolled active infection
- Pregnancy or nursing mothers
- Infection with HIV, hepatitis B or hepatitis C
- Any other significant medical, surgical, or psychiatric condition that may interfere with compliance with protocol regimen
- Other current malignancies apart from any in situ cancer or basal or squamous cell carcinoma
- Pediatric melanoma only: infants with transplacentally acquired melanoma; or children with brain metastases and malignant melanoma.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Trial of Vaccination With Autologous, Lethally Irradiated Tumor Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Colony Stimulating Factor in Pediatric and Adult Patients
The purpose of this study is to learn if a vaccine made from the patient's own tumor cells, then genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), will delay or stop the growth of the tumor. It will also look at the vaccine's effects on the immune system and the side effects of giving a vaccine made from a subject's own cancer cells.
Read the detailed description
The patient will have surgery to remove a portion of the tumor. This tumor is then brought to a special, certified laboratory where it is broken up into single cells and then washed.
Specially trained laboratory technicians then use a method known as adenoviral mediated gene transfer, which adds a new gene to the cancer calls. This gene causes the cells to make GM-CSF, a powerful hormone that stimulates the immune system. The cells are then given enough radiation so that they will never grow, but not enough to completely destroy them, developing a vaccine.
The patient is then injected with the vaccine on days 0, 7, 14, 28, and then every two weeks until the supply of vaccine has run out. The amount of vaccine that can be made depends upon the total amount of cells taken from the tumor. The actual injections are like childhood vaccinations that go under the skin or into muscle and a different place will be used for each injection.
It is hoped that the cancer cells that have been made to secrete the hormone GM-CSF will cause the patient's immune system to attack the cancer in other parts of the body.
If the tumor yields enough cells, the patient will also be given an injection of non-transduced irradiated tumor cells. Non-transduced means that the gene for GM-CSF has not been added to these cells as it has for the vaccines. This is done to measure the amount of reaction of the immune system caused by the vaccine. This injection is measuring delayed type hypersensitivity, or DTH.
The patient will be asked to undergo optional skin biopsies of the vaccine and DTH sites to see if an immune reaction is occuring at the injection sites 2 days after vaccine 1 and vaccine 5.
The following tests and procedures will be performed through out the study: physical exam, blood samples, immune studies, vital signs and physical exam.
At week 10 in the patient's treatment, or earlier if the doctor feels it is necessary, the patient will undergo a chest, abdomen and pelvic XT scan. A brain MRI will be performed if there were any abnormalities on the first brain MRI or if any new central nervous system symptoms have developed.
If the patient's disease has not disappeared or if new lesions have been found after the patient receives at least six vaccines, they may have the opportunity to undergo a second course of study treatment.
Patients may participate in this study until one of the following happens: All vaccine created from the tumor has been given to the patient; the patient's disease worsens; the patient experiences an unacceptable and/or harmful side effect; the patient becomes pregnant; the patient is unable to follow the study plan; or the patient's doctor feels it is no longer in the best interest of the patient to continue.
- Being tested
- GVAX
- Keywords
- GVAX, GM-CSF, Adenoviral mediated gene transfer, Pediatric Melanoma
- Medical subject headings
- Sarcoma, Clear Cell, Sarcoma, Alveolar Soft Part, Carcinoma, Renal Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GVAXBiological
4 vaccines every two weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | GVAX for Sarcoma / Renal Cell Patients Receives: Biological: GVAX |
| Treatment Arm B | Experimental | GVAX for Pediatric Melanoma Patients Receives: Biological: GVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and feasibility of preparation and administration of vaccine in patients with metastatic or locally advanced clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS) and translocation associated renal cell carcinoma (RCC)
Measured: Years
Secondary outcomes (1)
To determine the disease response, immune response, and overall survival rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2006
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, Clear CellStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Principal investigator, F. Stephen Hodi, MD, Dana-Farber Cancer Institute
- Investigators
- F. Stephen Hodi, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258687
- Sponsor's protocol ID
- 05-115
- Status last verified
- Mar 2021
- First submitted
- 23 Nov 2005
- Last updated
- 3 Mar 2021
- Results posted
- No
Publications
Soiffer R, Hodi FS, Haluska F, Jung K, Gillessen S, Singer S, Tanabe K, Duda R, Mentzer S, Jaklitsch M, Bueno R, Clift S, Hardy S, Neuberg D, Mulligan R, Webb I, Mihm M, Dranoff G. Vaccination with irradiated, autologous melanoma cells engineered to secrete granulocyte-macrophage colony-stimulating factor by adenoviral-mediated gene transfer augments antitumor immunity in patients with metastatic melanoma. J Clin Oncol. 2003 Sep 1;21(17):3343-50. doi: 10.1200/JCO.2003.07.005.
PubMed 12947071Salgia R, Lynch T, Skarin A, Lucca J, Lynch C, Jung K, Hodi FS, Jaklitsch M, Mentzer S, Swanson S, Lukanich J, Bueno R, Wain J, Mathisen D, Wright C, Fidias P, Donahue D, Clift S, Hardy S, Neuberg D, Mulligan R, Webb I, Sugarbaker D, Mihm M, Dranoff G. Vaccination with irradiated autologous tumor cells engineered to secrete granulocyte-macrophage colony-stimulating factor augments antitumor immunity in some patients with metastatic non-small-cell lung carcinoma. J Clin Oncol. 2003 Feb 15;21(4):624-30. doi: 10.1200/JCO.2003.03.091.
PubMed 12586798
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Vaccination With Autologous, Lethally Irradiated Tumor Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Colony Stimulating Factor in Pediatric and Adult Patients
- ClinicalTrials.gov ID
- NCT00258687
- Acronym / sponsor ID
- 05-115
- Keywords
- GVAX, GM-CSF, Adenoviral mediated gene transfer, Pediatric Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- Jan 2005 (actual)
- Primary completion
- Jul 2006 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 28 Nov 2005 (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 study is to learn if a vaccine made from the patient's own tumor cells, then genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), will delay or stop the growth of the tumor. It will also look at the vaccine's effects on the immune system and the side effects of giving a vaccine made from a subject's own cancer cells.
Detailed description
The patient will have surgery to remove a portion of the tumor. This tumor is then brought to a special, certified laboratory where it is broken up into single cells and then washed.
Specially trained laboratory technicians then use a method known as adenoviral mediated gene transfer, which adds a new gene to the cancer calls. This gene causes the cells to make GM-CSF, a powerful hormone that stimulates the immune system. The cells are then given enough radiation so that they will never grow, but not enough to completely destroy them, developing a vaccine.
The patient is then injected with the vaccine on days 0, 7, 14, 28, and then every two weeks until the supply of vaccine has run out. The amount of vaccine that can be made depends upon the total amount of cells taken from the tumor. The actual injections are like childhood vaccinations that go under the skin or into muscle and a different place will be used for each injection.
It is hoped that the cancer cells that have been made to secrete the hormone GM-CSF will cause the patient's immune system to attack the cancer in other parts of the body.
If the tumor yields enough cells, the patient will also be given an injection of non-transduced irradiated tumor cells. Non-transduced means that the gene for GM-CSF has not been added to these cells as it has for the vaccines. This is done to measure the amount of reaction of the immune system caused by the vaccine. This injection is measuring delayed type hypersensitivity, or DTH.
The patient will be asked to undergo optional skin biopsies of the vaccine and DTH sites to see if an immune reaction is occuring at the injection sites 2 days after vaccine 1 and vaccine 5.
The following tests and procedures will be performed through out the study: physical exam, blood samples, immune studies, vital signs and physical exam.
At week 10 in the patient's treatment, or earlier if the doctor feels it is necessary, the patient will undergo a chest, abdomen and pelvic XT scan. A brain MRI will be performed if there were any abnormalities on the first brain MRI or if any new central nervous system symptoms have developed.
If the patient's disease has not disappeared or if new lesions have been found after the patient receives at least six vaccines, they may have the opportunity to undergo a second course of study treatment.
Patients may participate in this study until one of the following happens: All vaccine created from the tumor has been given to the patient; the patient's disease worsens; the patient experiences an unacceptable and/or harmful side effect; the patient becomes pregnant; the patient is unable to follow the study plan; or the patient's doctor feels it is no longer in the best interest of the patient to continue.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Biological: GVAXGVAX for Sarcoma / Renal Cell Patients |
| Treatment Arm B | Experimental | Biological: GVAXGVAX for Pediatric Melanoma Patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- ECOG performance status 0 or 1
- Estimated life expectancy of greater than 6 months
- Greater than or equal to 4 weeks from chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy
- Greater than or equal to 6 months from prior bone marrow or peripheral blood stem cell (PBSC) transplant
- Histologically confirmed alveolar soft part sarcoma or clear cell sarcoma at any age.
Key exclusion criteria (6 listed)
- Uncontrolled active infection
- Pregnancy or nursing mothers
- Infection with HIV, hepatitis B or hepatitis C
- Any other significant medical, surgical, or psychiatric condition that may interfere with compliance with protocol regimen
- Other current malignancies apart from any in situ cancer or basal or squamous cell carcinoma
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 |
|---|---|---|
| GVAX4 vaccines every two weeks | Biological | Treatment Arm A, Treatment Arm B |
Primary outcome
To determine the safety and feasibility of preparation and administration of vaccine in patients with metastatic or locally advanced clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS) and translocation associated renal cell carcinoma (RCC)
Time frame: Years
1 secondary outcome
To determine the disease response, immune response, and overall survival rate
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 3 Mar 2021.
- Background: PubMed 12947071Soiffer R, Hodi FS, Haluska F, Jung K, Gillessen S, Singer S, Tanabe K, Duda R, Mentzer S, Jaklitsch M, Bueno R, Clift S, Hardy S, Neuberg D, Mulligan R, Webb I, Mihm M, Dranoff G. Vaccination with irradiated, autologous melanoma cells engineered to secrete granulocyte-macrophage colony-stimulating factor by adenoviral-mediated gene transfer augments antitumor immunity in patients with metastatic melanoma. J Clin Oncol. 2003 Sep 1;21(17):3343-50. doi: 10.1200/JCO.2003.07.005.
- Background: PubMed 12586798Salgia R, Lynch T, Skarin A, Lucca J, Lynch C, Jung K, Hodi FS, Jaklitsch M, Mentzer S, Swanson S, Lukanich J, Bueno R, Wain J, Mathisen D, Wright C, Fidias P, Donahue D, Clift S, Hardy S, Neuberg D, Mulligan R, Webb I, Sugarbaker D, Mihm M, Dranoff G. Vaccination with irradiated autologous tumor cells engineered to secrete granulocyte-macrophage colony-stimulating factor augments antitumor immunity in some patients with metastatic non-small-cell lung carcinoma. J Clin Oncol. 2003 Feb 15;21(4):624-30. doi: 10.1200/JCO.2003.03.091.
Related trials for Sarcoma, Clear Cell
Active, not recruiting
Clear Cell Chondrosarcoma in Italy
Chondrosarcoma
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
RecruitingPhase 2
A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma
HLA-A*0201 Positive Cells Present, Clear Cell Sarcoma (CCS)
Active, not recruitingPhase 3
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma
Active, not recruitingPhase 2
Agnostic Therapy in Rare Solid Tumors
Urachal Cancer, Parathyroid Carcinoma
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.
F. Stephen Hodi, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GVAX in people with Sarcoma, Clear Cell and Sarcoma, Alveolar Soft Part, run by Dana-Farber Cancer Institute at 2 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 9 inclusion and 6 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 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 determine the safety and feasibility of preparation and administration of vaccine in patients with metastatic or locally advanced clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS) and translocation associated renal cell carcinoma (RCC) (time frame: Years). 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 NCT00258687, which also lists 2 linked publications.
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 3 Mar 2021.