GlioblastomaPhase 2NCT00657267
Dose-Intense Temozolomide in Recurrent Glioblastoma
A Phase 2 study testing Temozolomide in people with Glioblastoma and Gliosarcoma, run by Patrick Y. Wen, MD at 6 sites in United States.
Trial summary
Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas. We will be using a different dose and schedule than the FDA approved dose and schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Gliosarcoma
- What is being tested?
- Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2008to Oct 2013
- 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
- Must provide independent consent or must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
- 18 years of age or older (of either sex, and of any race)
- Histologic diagnosis of GBM or gliosarcoma with an unequivocal progression by MRI or CT scan
- Must have received standard combined modality therapy as first-line treatment consisting of RT plus concomitant temozolomide followed by adjuvant temozolomide (at least 2 cycles of adjuvant temozolomide)
- Gadolinium MRI or contrast CT scan must be obtained within 14 days prior to registration, and must be on a steroid dose that has been stable for at least 5 days.
- Karnofsky Performance status of 60 or greater
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- Life expectancy of at least 8 weeks
- Recovered from the toxic effects of prior therapy, and 21 days must have elapsed since prior treatment with temozolomide
- o If a patient has residual toxicity from any previous treatment, toxicity must be ≤ Grade 1
- Laboratory tests within parameters outlined in the protocol
- Female subjects of childbearing potential \& male subjects with female partner of childbearing potential must agree to use a medically accepted method of contraception or be surgically sterilized prior to Screening, while receiving protocol-specified medication, and for 30 days after stopping the study medication
- Negative pregnancy test within 48 hours prior to dosing with the study drug (for female subjects of childbearing potential)
- Free of any clinically relevant disease that would, in the Principal Investigator's opinion, interfere with the conduct of the study or study evaluations
- Must be able to adhere to the dosing and visit schedules, and agree to record medication times, concomitant medications, and adverse events (AEs) accurately and consistently in a daily diary
- Unstained slides (at least 15 of 10 micron thickness, or 20 when < 10 micron thickness)or 1 tissue block must be available from the original diagnostic biopsy/surgery or from the biopsy/surgery recurrence
- Participants who have undergone recent resection of recurrent or progressive tumor will be eligible provided at least 2 weeks has elapsed since surgery, and subjects have recovered from surgical-related trauma
- Residual disease following resection of recurrent GBM or gliosarcoma is not mandated for eligibility into the study.
Who cannot join
- Participant has received a dosing schedule of temozolomide other than 75 mg/m2/day for 42 days during RT followed by adjuvant temozolomide at a dose of 150-200 mg/m2/day for 5 days of a 28-day schedule (standard dose adjustments for toxicity are allowed)
- Any other anti-tumor agent other than standard surgical resection, RT and temozolomide prior to enrollment or during the study period
- Received treatment with BCNU (Gliadel) wafers or GliaSite
- Progressed prior to receiving at least 2 cycles of adjuvant temozolomide
- Pregnant or intending to become pregnant during the study
- In a situation or condition that, in the opinion of the Investigator, may interfere with optimal participation in the study
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- Participating in any other clinical study in which an investigational drug is prescribed
- Allergic to or has sensitivity to the study drug or its excipients
- History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless he/she is in complete remission and has not received treatment for that particular disease for the past 3 or more years
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Wake Forest Univsersity
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase 2 Study of Dose-Intense Temozolomide in Recurrent Glioblastoma
Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas. We will be using a different dose and schedule than the FDA approved dose and schedule. The purpose of this study is to determine if patients that have failed standard temozolomide treatment will respond to temozolomide when given at a different dose and schedule (21 days every 28 days).
Read the detailed description
- Participants will be given a medication-dosing calendar for each treatment cycle. Each treatment cycle lasts 4 weeks (28 days) during which time they will be taking temozolomide orally once a day for the first three weeks.
- At the end of each cycle (day 28, +/- 2 days), the following procedures will be performed: Complete physical examination including a neurological exam; vital signs; a review of current medications and symptoms; blood samples; a pregnancy test for women of child-bearing potential; self-administered quality of life questionnaire; brain MRI or CT scan.
- Participants may continue taking temozolomide until their tumor grows or if they experience unacceptable side effects.
- Conditions
- Glioblastoma, Gliosarcoma
- Being tested
- Temozolomide
- Keywords
- recurrent glioblastoma, temodar, temozolomide
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
Taken orally daily for the first three weeks of a four-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Study | Experimental | Not described Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Progression Free Survival
Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Measured: 6 months
Secondary outcomes (3)
Overall Survival
Measured: From patient registration until end of study, assessed up to 54 months
Radiographic Response
Responders on study are those with a best response of either CR or PR. Per Modified Macdonald Criteria for lesions assessed by MRI/CT: Complete Response (CR) = Complete disappearance of all measurable and evaluable disease, no new lesions, no evidence of non-evaluable disease, with no steroids. Partial Response (PR) >/= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, no new lesions, with steroid dose @ time of response </= max dose w/in the first 8 weeks of therapy.
Measured: From patient registration until end of study, assessed up to 54 months
Time to Progression.
Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Measured: From patient registration until end of study, assessed up to 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2011
- Study completionOct 2013
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 GlioblastomaStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Y. Wen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, University of Pennsylvania, Wake Forest University Health Sciences, Tufts Medical Center, Dartmouth-Hitchcock Medical Center, Schering-Plough
- Responsible party
- Sponsor-investigator, Patrick Y. Wen, MD, Dana-Farber Cancer Institute
- Investigators
- Patrick Wen, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657267
- Sponsor's protocol ID
- 08-013
- Other IDs
- P05516
- Status last verified
- Feb 2014
- First submitted
- 8 Apr 2008
- Last updated
- 14 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Dose-Intense Temozolomide in Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT00657267
- Acronym / sponsor ID
- 08-013
- Conditions
- Glioblastoma, Gliosarcoma
- Keywords
- recurrent glioblastoma, temodar, temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Patrick Y. Wen, MDUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, University of Pennsylvania, Wake Forest University Health Sciences, Tufts Medical Center, Dartmouth-Hitchcock Medical Center, Schering-Plough
- Study start
- May 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Posted 14 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Temozolomide (Temodar) is an FDA approved medication for the treatment of newly diagnosed glioblastomas. In this study, we will be using temozolomide to treat recurrent glioblastomas. We will be using a different dose and schedule than the FDA approved dose and schedule. The purpose of this study is to determine if patients that have failed standard temozolomide treatment will respond to temozolomide when given at a different dose and schedule (21 days every 28 days).
Detailed description
- Participants will be given a medication-dosing calendar for each treatment cycle. Each treatment cycle lasts 4 weeks (28 days) during which time they will be taking temozolomide orally once a day for the first three weeks.
- At the end of each cycle (day 28, +/- 2 days), the following procedures will be performed: Complete physical examination including a neurological exam; vital signs; a review of current medications and symptoms; blood samples; a pregnancy test for women of child-bearing potential; self-administered quality of life questionnaire; brain MRI or CT scan.
- Participants may continue taking temozolomide until their tumor grows or if they experience unacceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Study | Experimental | Drug: Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Must provide independent consent or must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
- 18 years of age or older (of either sex, and of any race)
- Histologic diagnosis of GBM or gliosarcoma with an unequivocal progression by MRI or CT scan
- Must have received standard combined modality therapy as first-line treatment consisting of RT plus concomitant temozolomide followed by adjuvant temozolomide (at least 2 cycles of adjuvant temozolomide)
- Gadolinium MRI or contrast CT scan must be obtained within 14 days prior to registration, and must be on a steroid dose that has been stable for at least 5 days.
Key exclusion criteria (9 listed)
- Participant has received a dosing schedule of temozolomide other than 75 mg/m2/day for 42 days during RT followed by adjuvant temozolomide at a dose of 150-200 mg/m2/day for 5 days of a 28-day schedule (standard dose adjustments for toxicity are allowed)
- Any other anti-tumor agent other than standard surgical resection, RT and temozolomide prior to enrollment or during the study period
- Received treatment with BCNU (Gliadel) wafers or GliaSite
- Progressed prior to receiving at least 2 cycles of adjuvant temozolomide
- Pregnant or intending to become pregnant during 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 |
|---|---|---|
| TemozolomideAlso: TemodarTaken orally daily for the first three weeks of a four-week cycle. | Drug | Single-Arm Study |
Primary outcome
6 Month Progression Free Survival
Time frame: 6 months
Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
3 secondary outcomes
Overall Survival
Time frame: From patient registration until end of study, assessed up to 54 months
Radiographic Response
Time frame: From patient registration until end of study, assessed up to 54 months
Time to Progression.
Time frame: From patient registration until end of study, assessed up to 54 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
- 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.
Patrick Wen, MD principal investigator
Dana-Farber Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide in people with Glioblastoma and Gliosarcoma, run by Patrick Y. Wen, MD at 6 sites 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 9 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 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 14 Mar 2014). 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?
6 Month Progression Free Survival (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 14 Mar 2014.