AstrocytomaEarly Phase 1NCT02976441
Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
A Early Phase 1 study testing Radiation therapy, Temozolomide and Stem cell collection in people with Astrocytoma and Brainstem Glioma, run by Washington University School of Medicine.
Trial summary
The investigators hypothesize that this study will show that sufficient lymphocyte stem cell can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5 of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300 cells/mm^3 four weeks after stem cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma, Brainstem Glioma, Ependymoma
- What is being tested?
- Radiation therapy, Temozolomide and Stem cell collection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Feb 2018
- Phase
- Early 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
- Histologically confirmed newly diagnosed high grade glioma by pathology (WHO grade III or IV).
- At least 18 years of age.
- Karnofsky performance status ≥ 60%
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,500/mcl
- Platelets ≥ 100,000/mcl
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- Hematocrit ≥ 30%
- Absolute lymphocyte count ≥ 1000/mcl Blood transfusions are permitted to allow potential participant to meet these criteria.
- Post-operative treatment plan must include standard radiation and temozolomide.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- Prior treatment with radiation therapy, chemotherapy, immunotherapy, biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK, or gene therapy), or hormonal therapy. Glucocorticoid therapy is allowed.
- Anti-VEGF therapy within 6 weeks of registration.
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Currently receiving any investigational agents that might affect lymphocytes. Patients receiving Novocure are allowed on study.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to filgrastim or plerixafor or other agents used in the study.
- Fresh CNS bleed as evident by MRI or CT.
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- Contraindicated for anticoagulation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Known HIV-positivity.
About this study
Official title: Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
The investigators hypothesize that this study will show that sufficient lymphocyte stem cell can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5 of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300 cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.
- Conditions
- Astrocytoma, Brainstem Glioma, Ependymoma, Mixed Glioma, Oligodendroglioma, Optic Nerve Glioma
- Being tested
- Radiation therapy, Temozolomide, Stem cell collection, Stem cell infusion
- Medical subject headings
- Astrocytoma, Ependymoma, Glioma, Oligodendroglioma, Optic Nerve Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
TemozolomideDrug
Also called Temodar®
Stem cell collectionProcedure or surgery
Stem cell infusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Focal RT, Temozolomide, Stem Cell Collection/Reinfusion | Experimental | * Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide
* Focal radiation therapy: standard of care dose daily for approximately 6 weeks
* Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation
* 2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient
* Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide Receives: Radiation: Radiation therapy; Drug: Temozolomide; Procedure: Stem cell collection; Procedure: Stem cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event
The study will provide preliminary evidence of efficacy if ≥5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) ≥300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts.
Measured: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
Secondary outcomes (6)
Number of lymphocyte stem cells that can be harvested from this patient population
Measured: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.
Measured: 4 weeks after stem cell reinfusion
Duration of lymphocyte rise following stem cell reinfusion
Measured: Up to 6 months after stem cell reinfusion (approximately 9 months)
Changes in lymphocyte subtypes following collection and reinfusion
Lymphocyte subtypes will be monitored by flow cytometry at the time of stem cell collection, prior to autologous stem cell reinfusion, and then monthly for 6 months.
Measured: Up to 6 months after stem cell reinfusion (approximately 9 months)
Changes in series of cytokine levels following collection and reinfusion
Cytokine levels will be checked by ELISPOT at the time of stem cell collection, weekly during radiation therapy/temozolomide (up to 6 weeks), prior to autologous stem cell reinfusion, and then monthly for 6 months.
Measured: Up to 6 months after stem cell reinfusion (approximately 9 months)
Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events
the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event/toxicity reporting.
Measured: Up to 6 months after stem cell reinfusion (approximately 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Why it stopped: Physician decided not to go through with study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Li Campian, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976441
- Sponsor's protocol ID
- 15-x135
- Status last verified
- Feb 2017
- First submitted
- 23 Nov 2016
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
- ClinicalTrials.gov ID
- NCT02976441
- Acronym / sponsor ID
- 15-x135
- Conditions
- Astrocytoma, Brainstem Glioma, Ependymoma, Mixed Glioma, Oligodendroglioma, Optic Nerve Glioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Physician decided not to go through with study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 29 Nov 2016 (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 investigators hypothesize that this study will show that sufficient lymphocyte stem cell can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5 of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300 cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal RT, Temozolomide, Stem Cell Collection/Reinfusion | Experimental | Radiation: Radiation therapy, Drug: Temozolomide, Procedure: Stem cell collection, Procedure: Stem cell infusion* Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide * Focal radiation therapy: standard of care dose daily for approximately 6 weeks * Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation * 2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient * Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed newly diagnosed high grade glioma by pathology (WHO grade III or IV).
- At least 18 years of age.
- Karnofsky performance status ≥ 60%
- Normal bone marrow and organ function as defined below:
- Post-operative treatment plan must include standard radiation and temozolomide.
Key exclusion criteria (10 listed)
- Prior treatment with radiation therapy, chemotherapy, immunotherapy, biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK, or gene therapy), or hormonal therapy. Glucocorticoid therapy is allowed.
- Anti-VEGF therapy within 6 weeks of registration.
- A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- Currently receiving any investigational agents that might affect lymphocytes. Patients receiving Novocure are allowed on study.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to filgrastim or plerixafor or other agents used in the study.
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 |
|---|---|---|
| Radiation therapy | Radiation | Focal RT, Temozolomide, Stem Cell Collection/Reinfusion |
| TemozolomideAlso: Temodar® | Drug | Focal RT, Temozolomide, Stem Cell Collection/Reinfusion |
| Stem cell collection | Procedure or surgery | Focal RT, Temozolomide, Stem Cell Collection/Reinfusion |
| Stem cell infusion | Procedure or surgery | Focal RT, Temozolomide, Stem Cell Collection/Reinfusion |
Primary outcome
Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event
Time frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
The study will provide preliminary evidence of efficacy if ≥5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) ≥300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts.
6 secondary outcomes
Number of lymphocyte stem cells that can be harvested from this patient population
Time frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.
Time frame: 4 weeks after stem cell reinfusion
Duration of lymphocyte rise following stem cell reinfusion
Time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
Changes in lymphocyte subtypes following collection and reinfusion
Time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
Changes in series of cytokine levels following collection and reinfusion
Time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events
Time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Jian Li Campian, M.D., Ph.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Radiation therapy, Temozolomide and Stem cell collection in people with Astrocytoma and Brainstem Glioma, run by Washington University School of Medicine.
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: withdrawn, as of the sponsor's last update on 20 Feb 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 withdrawn before enrolling participants, so there are no results.
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?
Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event (time frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 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 20 Feb 2017.