GlioblastomaPhase 1NCT01702792
Derivation of Tumor Specific Hybridomas
A Phase 1 study testing Tumor Vaccine in people with Glioblastoma, run by Dartmouth-Hitchcock Medical Center.
Trial summary
This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Tumor Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to 6 May 2015
- 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
- Patients with confirmed new diagnosis of glioblastoma and who have a yield of at least 8x10(7) tumor cells obtained at the time of surgery
- Age > 18 years
- KPS Score of greater than or equal to 70
- Adequate bone marrow as evidenced by:
- Absolute lymphocyte count > 1,000/uL Platelet count > 50,000/uL
- Adequate renal function as evidenced by serum creatinine < 2.0
- Patients must be able to read, understand and provide informed consent to participate in the trial.
- Patients of childbearing potential must agree to use an effective form of contraception during the study and for 90 days following vaccination (an effective form of contraception is an oral contraceptive or a double barrier method)
Who cannot join
- A patient may not be enrolled in the trial if any of the following criteria are met:
- Patients receiving dexamethasone > 8 mg/day during the week before vaccination.
- Patients who are pregnant or lactating
- Patients with active second malignancy.
- Any other medical conditions, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
About this study
Official title: Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas
This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies.
Read the detailed description
The intradermal vaccine will be injected 20cm in the anterior thigh. Vaccination will be done twice and separated by one week. The first vaccination will be performed approximately 2 weeks after surgery.
Approximately one week after the second vaccination one or two vaccine-draining lymph node(s) will be removed. The lymph node(s) will be identified using SN technology. One or two lymph node(s) will be removed.
Lymph nodes will be processed for recovery of B cells and formation of hybridomas.
- Conditions
- Glioblastoma
- Being tested
- Tumor Vaccine
- Keywords
- Immunotherapy, cancer vaccine, glioblastoma, hybridoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor VaccineBiological
Also called Autologous Tumor Lysate and Montanide Emulsion
Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.
| Study group | Role | What they receive |
|---|---|---|
| Tumor Vaccine | Experimental | 1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity. Receives: Biological: Tumor Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hybridoma clones that produce anti-glioma antibodies
The primary technical endpoint demonstrating the feasibility of the pilot study will be based upon the total count of the number of generated hybridoma clones sourced from the dermal vaccine draining lymph nodes that are determined to be producing anti-glioma antibodies.
Measured: 6 months
Secondary outcomes (4)
Production of Antibodies
Secondary outcomes will include:
Determining how many hybridoma clones produce glioblastoma-specific antibodies. The initial secondary endpoint will include the counting of the number of hybridoma clones sourced from the dermal vaccine draining lymph nodes that generate specific glioma antibodies.
Measured: 6 months
Toxicity of Vaccine
- Determining toxicity of vaccine
Measured: 6 months
Clone Production Rate
Determining whether B cells sourced from the vaccine nodes produce more anti-tumor antibody hybridomas than the non-vaccine node. The rate of producing these clones will be compared according to the source of the B cells. Thus, B cells recovered from vaccine related nodes will be compared to B cells recovered from the non-vaccine node.
Measured: 6 months
Lymph Node Biopsy
Determine the safety and toxicity issues related to the Lymph Node Biopsy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startJan 2014
- Primary completion6 May 2015
- Study completion6 May 2015
Why it stopped: Investigator is leaving Dartmouth
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vermont
- Responsible party
- Sponsor
- Investigators
- Camilo Fadul, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702792
- Sponsor's protocol ID
- W12209
- Status last verified
- Apr 2018
- First submitted
- 3 Oct 2012
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas
- ClinicalTrials.gov ID
- NCT01702792
- Acronym / sponsor ID
- W12209
- Conditions
- Glioblastoma
- Keywords
- Immunotherapy, cancer vaccine, glioblastoma, hybridoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator is leaving Dartmouth
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- University of Vermont
- Study start
- Jan 2014
- Primary completion
- 6 May 2015 (actual)
- Study completion
- 6 May 2015 (actual)
- First posted
- 8 Oct 2012 (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 is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies.
Detailed description
The intradermal vaccine will be injected 20cm in the anterior thigh. Vaccination will be done twice and separated by one week. The first vaccination will be performed approximately 2 weeks after surgery.
Approximately one week after the second vaccination one or two vaccine-draining lymph node(s) will be removed. The lymph node(s) will be identified using SN technology. One or two lymph node(s) will be removed.
Lymph nodes will be processed for recovery of B cells and formation of hybridomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor Vaccine | Experimental | Biological: Tumor Vaccine1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with confirmed new diagnosis of glioblastoma and who have a yield of at least 8x10(7) tumor cells obtained at the time of surgery
- Age > 18 years
- KPS Score of greater than or equal to 70
- Adequate bone marrow as evidenced by:
- Absolute lymphocyte count > 1,000/uL Platelet count > 50,000/uL
Key exclusion criteria (5 listed)
- Patients receiving dexamethasone > 8 mg/day during the week before vaccination.
- Patients who are pregnant or lactating
- Patients with active second malignancy.
- Any other medical conditions, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
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 VaccineAlso: Autologous Tumor Lysate and Montanide EmulsionTumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG. | Biological | Tumor Vaccine |
Primary outcome
number of hybridoma clones that produce anti-glioma antibodies
Time frame: 6 months
The primary technical endpoint demonstrating the feasibility of the pilot study will be based upon the total count of the number of generated hybridoma clones sourced from the dermal vaccine draining lymph nodes that are determined to be producing anti-glioma antibodies.
4 secondary outcomes
Production of Antibodies
Time frame: 6 months
Toxicity of Vaccine
Time frame: 6 months
Clone Production Rate
Time frame: 6 months
Lymph Node Biopsy
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Investigator is leaving Dartmouth). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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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.
Camilo Fadul, MD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tumor Vaccine in people with Glioblastoma, run by Dartmouth-Hitchcock Medical Center.
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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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: Investigator is leaving Dartmouth). 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?
number of hybridoma clones that produce anti-glioma antibodies (time frame: 6 months). 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 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.