Brain TumorPhase 2NCT00763750
PPX, Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors
A Phase 2 study testing PPX +TMZ+XRT in people with Brain Tumor, run by howard safran at 1 site in United States.
Trial summary
The purpose of this study is to determine the antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- PPX +TMZ+XRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must have histopathologically confirmed, newly diagnosed, glioblastoma multiforme or anaplastic glioma (anaplastic astrocytoma [AA], anaplastic oligodendroglioma, and anaplastic oligoastrocytoma) and have not had a complete surgical resection.
- Patients must be 18 years of age or older.
- Patients must have a Zubrod performance status 0-2.
- Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED). Patients may be on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any anti-epileptic drugs.
- Patients must not have received prior chemotherapy, radiation or any experimental therapy for their glioblastoma.
- Patients may not be breast-feeding a child.
Show all 17Show fewer
- Female patients must either be not of child bearing potential or have a negative pregnancy test within 14 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Female patients must be using an acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) OR female patients must be at least 1-year post-menopausal or surgically sterile during their participation in this study (from the time they sign the consent form) to prevent pregnancy. Male patients must be surgically sterile or using an acceptable method of contraception during their participation in this study (from the time they sign the consent form) to prevent pregnancy in a partner
- Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast. Patients with prior malignancies must be disease-free for ≥ 2 years.
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count > 1,500/ul
- Platelets > 100,000/ul
- Hemoglobin > 8 gm/dL
- Total bilirubin < 1.5 x ULN
- Creatinine < 1.5 x ULN
- Patient must have the capacity to understand and the willingness to sign a written informed consent document.
- Patient must be able to tolerate MRIs. CT scans can NOT be substituted for MRI in this study.
Who cannot join
- Recurrent malignant gliomas.
- Tumor foci detected below the tentorium or beyond the cranial vault.
- Allergy to gadolinium or contraindication to MRI scan.
- Patients who have received any form of brachytherapy or radiosurgery for their glioblastoma prior to start of standard radiation.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PPX.
- Uncontrolled intercurrent illness including, but not limited to, hypertension 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 women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with PPX, breastfeeding should be discontinued if the mother is treated with PPX.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BrUOG-Brain-223-A Phase II Study of PPX (CT-2103), Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors (CTI # CT2103) Principal Investigator: Howard Safran, M.D.
The purpose of this study is to determine the antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.
Read the detailed description
To evaluate the safety/tolerability and potential antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.
- Conditions
- Brain Tumor
- Being tested
- PPX +TMZ+XRT
- Keywords
- glioblastoma multiforme or anaplastic glioma
- Medical subject headings
- Brain Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPX +TMZ+XRTDrug
Also called PPX TMZ
PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)
| Study group | Role | What they receive |
|---|---|---|
| PPX +TMZ+XRT | Experimental | XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36 Receives: Drug: PPX +TMZ+XRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Assessed for Toxicity According to CTC Version 3.0
Measured: Throughout the entire study until patient is removed from study an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- howard safran
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, MaineHealth
- Responsible party
- Sponsor-investigator, howard safran, Brown University
- Investigators
- Howard Safran, MD, Principal investigator, BrUOG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763750
- Sponsor's protocol ID
- BrUOG-Brain-223
- Status last verified
- Feb 2020
- First submitted
- 30 Sep 2008
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrUOG-Brain-223-A Phase II Study of PPX (CT-2103), Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors (CTI # CT2103) Principal Investigator: Howard Safran, M.D.
- ClinicalTrials.gov ID
- NCT00763750
- Acronym / sponsor ID
- BrUOG-Brain-223
- Conditions
- Brain Tumor
- Keywords
- glioblastoma multiforme or anaplastic glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- howard safranUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, MaineHealth
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Posted 16 Dec 2013
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 determine the antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.
Detailed description
To evaluate the safety/tolerability and potential antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPX +TMZ+XRT | Experimental | Drug: PPX +TMZ+XRTXRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histopathologically confirmed, newly diagnosed, glioblastoma multiforme or anaplastic glioma (anaplastic astrocytoma [AA], anaplastic oligodendroglioma, and anaplastic oligoastrocytoma) and have not had a complete surgical resection.
- Patients must be 18 years of age or older.
- Patients must have a Zubrod performance status 0-2.
- Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED). Patients may be on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any anti-epileptic drugs.
- Patients must not have received prior chemotherapy, radiation or any experimental therapy for their glioblastoma.
Key exclusion criteria (7 listed)
- Recurrent malignant gliomas.
- Tumor foci detected below the tentorium or beyond the cranial vault.
- Allergy to gadolinium or contraindication to MRI scan.
- Patients who have received any form of brachytherapy or radiosurgery for their glioblastoma prior to start of standard radiation.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PPX.
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 |
|---|---|---|
| PPX +TMZ+XRTAlso: PPX TMZPPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays) | Drug | PPX +TMZ+XRT |
Primary outcome
Number of Patients Assessed for Toxicity According to CTC Version 3.0
Time frame: Throughout the entire study until patient is removed from study an average of 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Howard Safran, MD principal investigator
BrUOG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PPX +TMZ+XRT in people with Brain Tumor, run by howard safran 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 17 inclusion and 7 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 17 Feb 2020. 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 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?
Yes. Results are posted in the registry (first posted 16 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patients Assessed for Toxicity According to CTC Version 3.0 (time frame: Throughout the entire study until patient is removed from study an average of 6 weeks). 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 17 Feb 2020.