SarcomaPhase 1/2ADCVCTASTNCT01883518
Autologous Dendritic Cell Vaccine in Patients With Soft Tissue Sarcoma
A Phase 1/2 study testing Autologous dendritic cell vaccine in people with Sarcoma and Neoplasms, Connective and Soft Tissue, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Neoplasms, Connective and Soft Tissue
- What is being tested?
- Autologous dendritic cell vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2013to Sep 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age of 18 or older
- ECOG performance score 0 or 1
- Histologically proven soft tissue sarcoma
- Unresectable or metastatic soft tissue sarcoma
- Ability to give written informed consent
- Objective measured and measurable tumor lesions
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- The failure of standard therapy
- Adequate amount of material for genetic research
- No active or chronic infection with HIV, Hepatitis B or Hepatitis C
- Men/Women of childbearing potential must use adequate contraception
- Hematology, liver function and renal function lab tests within required parameters
Who cannot join
- Untreated or uncontrolled brain metastases.
- History of other active malignancy within last 2 years, except adequately treated other soft tissue sarcoma.
- Autoimmune disease (vitiligo is not a basis for exclusion).
- Serious uncontrolled medical disorder or active infection that would impede treatment.
- Underlying medical or psychiatric condition that would cause administration vaccine
- Any non-oncology vaccine therapy up to 1 month before or after any dose of vaccine
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- Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration; other investigational therapies; chronic use of systemic corticosteroids (however, a low stable dose steroid for mild brain edema or adrenal insufficiency is allowed; topical and inhaled standard dose corticosteroids are allowed).
- Dementia or significantly altered mental status that would prohibit understanding or rendering of informed consent and compliance with protocol requirements.
- Pregnant or breastfeeding women.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious) illness.
Trial locations and contacts
1 site in 1 country.
Russia1 site
N. N. Petrov Research Institute of oncology
Saint Petersburg, 197758
About this study
Official title: Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma
The purpose of this study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas
Read the detailed description
Vaccination is carried out on the planned days ± 3 days
- All examinations must be performed before the vaccine is administered.
- Full physical examination.
- Assessment of vital signs (blood pressure, temperature, heart rate), the general condition of the patient and physical activity.
- Evaluation of concomitant therapy.
- Assessment of vital signs.
- Laboratory safety and immunological indicators
- Assessment of adverse events, symptoms and syndromes of the disease.
- Introduction of CV in accordance with the dose determined for a given vaccination (see section 9.2. - procedures for delivery and use)
- After administration, patients are observed for at least 1 hour. An assessment of vital indicators. Undesirable effects detected at the introduction are recorded.
- Conditions
- Sarcoma, Neoplasms, Connective and Soft Tissue
- Being tested
- Autologous dendritic cell vaccine
- Keywords
- Fibrosarcoma, Neurofibrosarcoma, Histiocytoma, Histiocytoma, Malignant Fibrous, Chondrosarcoma, Synovial Sarcoma, Leiomyosarcoma, Liposarcoma, Myosarcoma, Rhabdomyosarcoma, Sarcoma, Alveolar Soft Part, NY-ESO-1, MAGE, MAGE A3, Vaccine, Immunotherapy
- Medical subject headings
- Sarcoma, Neoplasms, Connective and Soft Tissue, Fibrosarcoma, Neurofibrosarcoma, Histiocytoma, Histiocytoma, Malignant Fibrous, Chondrosarcoma, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous dendritic cell vaccineBiological
Also called Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens, CTA vaccine, DC vaccine, DC CTA vaccine
Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens
| Study group | Role | What they receive |
|---|---|---|
| Autologous dendritic cell vaccine | Experimental | Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens Receives: Biological: Autologous dendritic cell vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas
Achieving a six-month time to progression (PFS) 40% of patients receiving ADKV loaded with allogeneic tumor lysate expressing PTA in patients with soft tissue sarcomas
Measured: 6 month
Secondary outcomes (4)
Median progression-free survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works
Measured: 6 month
Median overall survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that half of the patients in a group of patients diagnosed with the disease are still alive. In a clinical trial, measuring the median overall survival is one way to see how well a new treatment works
Measured: 6 month
Objective response rate
The percentage of patients whose cancer shrinks or disappears after treatment.
Measured: 6 mounth
Assess biological response of tumors
Сhanging level of T lymphocytes subpopulation in peripheral blood
Measured: 6 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuriy Komarov, PhD, Study chair, N. N. Petrov Research Institute of oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883518
- Sponsor's protocol ID
- MC-01-2013
- Acronym
- ADCVCTAST
- Status last verified
- Nov 2019
- First submitted
- 17 Jun 2013
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomized Single-center Study Phase II Evaluating the Efficacy and Toxicity of Autologous Dendritic Cell Vaccine Loaded With Allogeneic Tumor Lysate Expression of Cancer Testis Antigens in Patients With Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01883518
- Acronym / sponsor ID
- ADCVCTAST / MC-01-2013
- Conditions
- Sarcoma, Neoplasms, Connective and Soft Tissue
- Keywords
- Fibrosarcoma, Neurofibrosarcoma, Histiocytoma, Histiocytoma, Malignant Fibrous, Chondrosarcoma, Synovial Sarcoma, Leiomyosarcoma, Liposarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 21 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 study is to achieving a six-month progression free survival (PFS) of patients receiving autologous dendritic cell vaccine (ADKV) loaded with allogeneic tumor lysate expression of cancer-testis antigens (CTA) in patients with soft tissue sarcomas
Detailed description
Vaccination is carried out on the planned days ± 3 days
- All examinations must be performed before the vaccine is administered.
- Full physical examination.
- Assessment of vital signs (blood pressure, temperature, heart rate), the general condition of the patient and physical activity.
- Evaluation of concomitant therapy.
- Assessment of vital signs.
- Laboratory safety and immunological indicators
- Assessment of adverse events, symptoms and syndromes of the disease.
- Introduction of CV in accordance with the dose determined for a given vaccination (see section 9.2. - procedures for delivery and use)
- After administration, patients are observed for at least 1 hour. An assessment of vital indicators. Undesirable effects detected at the introduction are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous dendritic cell vaccine | Experimental | Biological: Autologous dendritic cell vaccineAutologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- age of 18 or older
- ECOG performance score 0 or 1
- Histologically proven soft tissue sarcoma
- Unresectable or metastatic soft tissue sarcoma
- Ability to give written informed consent
Key exclusion criteria (10 listed)
- Untreated or uncontrolled brain metastases.
- History of other active malignancy within last 2 years, except adequately treated other soft tissue sarcoma.
- Autoimmune disease (vitiligo is not a basis for exclusion).
- Serious uncontrolled medical disorder or active infection that would impede treatment.
- Underlying medical or psychiatric condition that would cause administration vaccine
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 vaccineAlso: Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens, CTA vaccine, DC vaccine, DC CTA vaccineAutologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens | Biological | Autologous dendritic cell vaccine |
Primary outcome
Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas
Time frame: 6 month
Achieving a six-month time to progression (PFS) 40% of patients receiving ADKV loaded with allogeneic tumor lysate expressing PTA in patients with soft tissue sarcomas
4 secondary outcomes
Median progression-free survival
Time frame: 6 month
Median overall survival
Time frame: 6 month
Objective response rate
Time frame: 6 mounth
Assess biological response of tumors
Time frame: 6 mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
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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.
Yuriy Komarov, PhD study chair
N. N. Petrov Research Institute of oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous dendritic cell vaccine in people with Sarcoma and Neoplasms, Connective and Soft Tissue, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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 11 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. 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 Russia. 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 combined 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.
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?
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?
Achieving a six-month progression free survival (PFS) of patients receiving ADKV with soft tissue sarcomas (time frame: 6 month). 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 20 Nov 2019.