Brain TumorsPhase 1NCT00893945
Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells Administered to Patients With Brain Tumors
A Phase 1 study testing DC/AAT, DC/AAT-Flu and DC/KLH in people with Brain Tumors, run by Rockefeller University at 1 site in United States.
Trial summary
This study involves cancer research and the purpose is to assess the safety and activity of a type of vaccine as immune therapy for cancer. This vaccine will be made from each participant's own immune cells (called dendritic cells) obtained by blood donation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors
- What is being tested?
- DC/AAT, DC/AAT-Flu and DC/KLH
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening to determine eligibility (with the exception of HLA haplotyping) will be completed within 45 days fo study entry.
- Disease Characteristics
- Histologically confirmed brain cancers, reviewed at MSKCC. Pathologic examination will be of surgical resection specimens deemed of suitable quality for definitive diagnosis by the histopathologist.
- Primary Brain Tumors:
- Anaplastic astrocytoma
- Glioblastoma multiforme
Show all 44Show fewer
- Anaplastic oligodendroglioma
- Malignant mixed oligoastrocytoma
- Secondary (metastatic) brain tumors - newly diagnosed or recurrent disease
- All histological grade of disease accepted
- Surgically accessible tumor for which resection is indicated. Tumors may be from initial resections or re-resections. Recovery of a minimum of 1x10^7 tumor cells ex vivo is required.
- Patients with primary brain tumors must have been previously treated with conventional therapy.
- Prior/Concurrent Therapy
- Recovered from toxicity of any prior therapy
- Biologic Therapy
- No concurrent other immunotherapy and no prior immunotherapy with any of the components of the current regimen (autologous DCs, cancer cells, or KLH)
- Chemotherapy:
- No concurrent immunomodulatory or chemotherapy therapy
- Chemotherapy, including temozolomide and local chemotherapies such as Gliadel Wafers, must be deferred until after last post-vaccine leukapheresis
- Endocrine evaluation/therapy:
- steroid dose no greater than 1mg daily dexamethasone (or equivalent)
- Radiotherapy:
- No concurrent brain radiation
- Surgery:
- Surgical resection must have been completed independently of this study, and suitable samples obtained for vaccine production
- Patient Characteristics
- Age: 18 and over, able to give written informed consent. May be obtained through use of legal representation such as a health care proxy
- Performance status: Karnofsky 60-100%
- Life expectancy: at least 4-6 months
- Hematopoietic:
- WBC greater than 3,800
- Absolute lymphocytes greater than 500
- Absolute neutrophil counter great than 1,500/mm^3
- Platelets greater than 100,000/mm^3
- Hb greater than or equal to 10g/dL
- Hepatic: bilirubin less than 2mg/dL OR SGOT less than 2x ULN
- Renal: Creatinine no greater than 2mg/dL
- Cardiovascular:
- No NYHA class III/IV status
- No active angina, uncontrolled clinically significant cardiac arrythmia, recent (6 months) myocardial infarction
- Pulmonary: No symptomatic pulmonary disease or pulse oximetry less than 93% on room air
- Endocrine: No history of autoimmune thyroid disease
- Radiographic: baseline contrast-enhanced MRI or CT scan of brain post surgical resection
- Coagulation: No unexplained INR >2
Who cannot join
- No active infection requiring antibiotics
- No history of HIV, hepatitis B or hepatitis C virus infection, no history of high risk behavior for such infection (intravenous drug abuse, men having unprotected sex with men). Laboratory evaluation for HIV, hepatitis B, hepatitis C to be obtained prior to study entry
- No history of hypersensitivity to vaccine components
- No history of autoimmune or vasculitic disease (including but not limited to systemic lupus erythematosis, Hashimoto's thyroiditis, rheumatoid arthritis, systemic necrotizing vasculitides (polyarteritis nodosa group), hypersensitivity vasculitis, Wegener's granulomatosis), scleroderma, multiple sclerosis, juvenile-onset insulin-dependent diabetes
- No medical or psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements
- No alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells (DC/AAT) Administered Intradermally to Cancer Patients With Brain Tumors
This study involves cancer research and the purpose is to assess the safety and activity of a type of vaccine as immune therapy for cancer.
This vaccine will be made from each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells (DCs) are immune cells whose role is to identify foreign material in the body (such as bacteria, viruses, or tumor cells).
When DCs recognize this material, they use it to activate other cells of the immune system to mount an attack against that foreign material. In the Laboratory of Molecular Neuro-Oncology, each participant's DCs will be loaded with samples of their own tumor cells that were obtained at surgical resection. These tumor cells are killed in the laboratory using a special protocol, and then "fed" to the DCs. The DCs "eat" this material, and these "fed" DCs make up the vaccine.
Read the detailed description
If you are eligible, and you decide to join this research study, you will get two to three shots of the experimental vaccine, each three weeks apart.
You will then have a follow up period where we will monitor you and your medical records for any affects of the experimental treatment.
- Conditions
- Brain Tumors
- Being tested
- DC/AAT, DC/AAT-Flu, DC/KLH
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC/AATDrug
Also called Dendritic cell/autologous apoptotic tumor
Autologous dendritic cells that have been co-cultured with autologous apoptotic tumor (AAT) specimens.
DC/AAT-FluDrug
Also called dendritic cell/flu-infected autologous apoptotic tumor
Intradermal injection of Autologous dendritic cell vaccine (DC/AAT-Flu) after co-culture with flu-infected AAT
DC/KLHDrug
Also called dendritic cell/Keyhole Limplet hemocyanin
Intradermal injection of Autologous dendritic cell vaccine (DC/KLH) which have been co-cultured with Keyhole pimpit hemocyanin (KLH) as a positive control.
| Study group | Role | What they receive |
|---|---|---|
| DC/AAT vaccine | Experimental | Intradermal injection of 3 Autologous dendritic cell vaccines (DC/AAT, DC/AAT-flu, DC/KLH) that have been co-cultured with autologous apoptotic tumor specimens. Receives: Drug: DC/AAT; Drug: DC/AAT-Flu; Drug: DC/KLH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity- assessment of safety and tolerability
Measured: week 0 to week 9
Secondary outcomes (2)
Measurable disease
Measured: baseline and after completion of vaccination
Activity-monitoring both clinical and immunologic parameters
Measured: week 0 to week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJun 2007
- Primary completionDec 2013
- Study completionDec 2013
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 Brain TumorsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Robert Darnell, MD, PhD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893945
- Sponsor's protocol ID
- RDA-0611
- Status last verified
- Dec 2014
- First submitted
- 5 Dec 2008
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Frank MO, Kaufman J, Parveen S, Blachere NE, Orange DE, Darnell RB. Dendritic cell vaccines containing lymphocytes produce improved immunogenicity in patients with cancer. J Transl Med. 2014 Dec 5;12:338. doi: 10.1186/s12967-014-0338-3.
PubMed 25475068
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Autologous Dendritic Cells Pulsed With Autologous Apoptotic Tumor Cells (DC/AAT) Administered Intradermally to Cancer Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT00893945
- Acronym / sponsor ID
- RDA-0611
- Conditions
- Brain Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- Jun 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 May 2009 (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.
This study involves cancer research and the purpose is to assess the safety and activity of a type of vaccine as immune therapy for cancer.
This vaccine will be made from each participant's own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells (DCs) are immune cells whose role is to identify foreign material in the body (such as bacteria, viruses, or tumor cells).
When DCs recognize this material, they use it to activate other cells of the immune system to mount an attack against that foreign material. In the Laboratory of Molecular Neuro-Oncology, each participant's DCs will be loaded with samples of their own tumor cells that were obtained at surgical resection. These tumor cells are killed in the laboratory using a special protocol, and then "fed" to the DCs. The DCs "eat" this material, and these "fed" DCs make up the vaccine.
Detailed description
If you are eligible, and you decide to join this research study, you will get two to three shots of the experimental vaccine, each three weeks apart.
You will then have a follow up period where we will monitor you and your medical records for any affects of the experimental treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC/AAT vaccine | Experimental | Drug: DC/AAT, Drug: DC/AAT-Flu, Drug: DC/KLHIntradermal injection of 3 Autologous dendritic cell vaccines (DC/AAT, DC/AAT-flu, DC/KLH) that have been co-cultured with autologous apoptotic tumor specimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (44 listed)
- Screening to determine eligibility (with the exception of HLA haplotyping) will be completed within 45 days fo study entry.
- Disease Characteristics
- Histologically confirmed brain cancers, reviewed at MSKCC. Pathologic examination will be of surgical resection specimens deemed of suitable quality for definitive diagnosis by the histopathologist.
- Secondary (metastatic) brain tumors - newly diagnosed or recurrent disease
- Surgically accessible tumor for which resection is indicated. Tumors may be from initial resections or re-resections. Recovery of a minimum of 1x10^7 tumor cells ex vivo is required.
Key exclusion criteria (6 listed)
- No active infection requiring antibiotics
- No history of HIV, hepatitis B or hepatitis C virus infection, no history of high risk behavior for such infection (intravenous drug abuse, men having unprotected sex with men). Laboratory evaluation for HIV, hepatitis B, hepatitis C to be obtained prior to study entry
- No history of hypersensitivity to vaccine components
- No history of autoimmune or vasculitic disease (including but not limited to systemic lupus erythematosis, Hashimoto's thyroiditis, rheumatoid arthritis, systemic necrotizing vasculitides (polyarteritis nodosa group), hypersensitivity vasculitis, Wegener's granulomatosis), scleroderma, multiple sclerosis, juvenile-onset insulin-dependent diabetes
- No medical or psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements
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 |
|---|---|---|
| DC/AATAlso: Dendritic cell/autologous apoptotic tumorAutologous dendritic cells that have been co-cultured with autologous apoptotic tumor (AAT) specimens. | Drug | DC/AAT vaccine |
| DC/AAT-FluAlso: dendritic cell/flu-infected autologous apoptotic tumorIntradermal injection of Autologous dendritic cell vaccine (DC/AAT-Flu) after co-culture with flu-infected AAT | Drug | DC/AAT vaccine |
| DC/KLHAlso: dendritic cell/Keyhole Limplet hemocyaninIntradermal injection of Autologous dendritic cell vaccine (DC/KLH) which have been co-cultured with Keyhole pimpit hemocyanin (KLH) as a positive control. | Drug | DC/AAT vaccine |
Primary outcome
Toxicity- assessment of safety and tolerability
Time frame: week 0 to week 9
2 secondary outcomes
Measurable disease
Time frame: baseline and after completion of vaccination
Activity-monitoring both clinical and immunologic parameters
Time frame: week 0 to week 9
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 23 Dec 2014.
- Derived from this study: PubMed 25475068Frank MO, Kaufman J, Parveen S, Blachere NE, Orange DE, Darnell RB. Dendritic cell vaccines containing lymphocytes produce improved immunogenicity in patients with cancer. J Transl Med. 2014 Dec 5;12:338. doi: 10.1186/s12967-014-0338-3.
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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 Darnell, MD, PhD principal investigator
Rockefeller University
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 DC/AAT, DC/AAT-Flu and DC/KLH in people with Brain Tumors, run by Rockefeller University 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 44 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 23 Dec 2014. 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 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?
Toxicity- assessment of safety and tolerability (time frame: week 0 to week 9). 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 NCT00893945, 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 23 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.