Recurrent Central Nervous System NeoplasmPhase 2NCT00619112
Temozolomide in Treating Patients With Recurrent High-Grade Glioma
A Phase 2 study testing temozolomide in people with Recurrent Central Nervous System Neoplasm, run by University of California, San Francisco at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent high-grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Central Nervous System Neoplasm
- What is being tested?
- temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 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 with radiographically proven recurrent, intracranial malignant glioma will be eligible for this protocol.
- All patients must sign an informed consent
- Patients must have had external beam radiation; there is no limit to the number of prior chemotherapies used.
- Patients must be > 18 years old, and with a life expectancy > 8 weeks.
- Patients must have a Karnofsky performance status of > 60.
- At the time of registration: Patients must have recovered from the toxic effects of prior therapy:
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- Patients must have adequate bone marrow function.
- Patients must have shown unequivocal radiographic evidence for tumor progression by MRI
- Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: They have recovered from the effects of surgery. Residual disease following resection of recurrent intracranial malignant glioma is not mandated for eligibility into the study.
- Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 42 days from the completion of radiation therapy to study entry.
- Patients with prior therapy that included interstitial brachytherapy, stereotactic radiosurgery, or Gliadel wafers must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or MR spectroscopy or surgical documentation of disease.
- Male and female patients with reproductive potential must use an approved contraceptive method
Who cannot join
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
- Patients must not have active infection or serious intercurrent medical illness.
- Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent high-grade glioma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the efficacy, as measured by 6-month progression-free survival, of a dose-intense temozolomide treatment schedule in patients with recurrent high-grade glioma.
Secondary
- Assess the toxicities of this dose-intense temozolomide.
- Determine the overall survival of patients treated with this dose-intense schedule.
- Determine whether methylation status of the MGMT gene within patients' tumors predicts greater efficacy (progression-free survival), in patients treated on this protocol.
- Determine whether patients' tumors have functional alterations of the mismatch repair (MMR) system by PCR analysis for microsatellite instability (MSI) and whether such alterations may influence outcome in patients treated on this protocol.
- Determine how initial success with temozolomide may influence outcome in recurrent patients treated on this protocol by evaluating patients progressing after two first-line adjuvant courses of temozolomide, patients progressing within 6 months after the 6th adjuvant course of temozolomide, and patients progressing 6 months after temozolomide is voluntarily discontinued.
OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and days 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Formalin-fixed paraffin-embedded tissue blocks or unstained paraffin slides from available surgical samples are evaluated for molecular abnormalities in the tumor, including (but not limited to) MGMT status and microsatellite instability.
After completion of study therapy, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 40 patients with WHO II grade 4 tumors (glioblastoma multiforme [GBM]) and 20 patients with WHO II grade 3 tumors (non-GBM) will be accrued for this study.
- Being tested
- temozolomide
- Keywords
- adult glioblastoma, adult gliosarcoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, recurrent adult brain tumor
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma, Astrocytoma, Oligodendroglioma, Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Also called temodar
single arm study
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide | Experimental | single arm trial; Patients treated with temozolomide at a dose of 150mg/m2 daily for seven consecutive days of every other week. One 28-day cycle will include treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14 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
Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival
Measured: First day of treatment until progression or until 6 months mark
Secondary outcomes (6)
Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.
Progression-free survival data (obtained for Primary Outcome Measure) was correlated with tumor MGMT (O(6)-methylguanine-DNA methyltransferase) promoter methylation status, obtained from patients as part of the study.
Measured: First day of treatment until progression or until 6 months mark
Overall Survival
Measured: up to 2 years after treatment
Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System
PCR analysis of tumor tissue for microsatellite instability (MSI). Tissue was obtained during surgeries prior this study.
Measured: prior to start of study
Patients Progressing After Two First-line Adjuvant Courses of Temozolomide
Measured: After two first-line adjuvant courses of temozolomide
Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide
Measured: Within 6 months after 6th adjuvant course of temozolomide
Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued
Measured: From beginning of voluntarily temozolomide discontinued up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2011
- Study completionSep 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Central Nervous System NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nicholas A. Butowski, MD, Principal investigator, University of California, San FranciscoSusan M. Chang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619112
- Sponsor's protocol ID
- UCSF-07107
- Other IDs
- SPRI-UCSF-H44867-31182-01
- Status last verified
- Jan 2018
- First submitted
- 19 Feb 2008
- Last updated
- 31 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Han SJ, Rolston JD, Molinaro AM, Clarke JL, Prados MD, Chang SM, Berger MS, DeSilva A, Butowski NA. Phase II trial of 7 days on/7 days off temozolmide for recurrent high-grade glioma. Neuro Oncol. 2014 Sep;16(9):1255-62. doi: 10.1093/neuonc/nou044. Epub 2014 Mar 26.
PubMed 24670608
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma
- ClinicalTrials.gov ID
- NCT00619112
- Acronym / sponsor ID
- UCSF-07107
- Keywords
- adult glioblastoma, adult gliosarcoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, recurrent adult brain tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 29 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent high-grade glioma.
Detailed description
OBJECTIVES:
Primary
- Determine the efficacy, as measured by 6-month progression-free survival, of a dose-intense temozolomide treatment schedule in patients with recurrent high-grade glioma.
Secondary
- Assess the toxicities of this dose-intense temozolomide.
- Determine the overall survival of patients treated with this dose-intense schedule.
- Determine whether methylation status of the MGMT gene within patients' tumors predicts greater efficacy (progression-free survival), in patients treated on this protocol.
- Determine whether patients' tumors have functional alterations of the mismatch repair (MMR) system by PCR analysis for microsatellite instability (MSI) and whether such alterations may influence outcome in patients treated on this protocol.
- Determine how initial success with temozolomide may influence outcome in recurrent patients treated on this protocol by evaluating patients progressing after two first-line adjuvant courses of temozolomide, patients progressing within 6 months after the 6th adjuvant course of temozolomide, and patients progressing 6 months after temozolomide is voluntarily discontinued.
OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and days 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Formalin-fixed paraffin-embedded tissue blocks or unstained paraffin slides from available surgical samples are evaluated for molecular abnormalities in the tumor, including (but not limited to) MGMT status and microsatellite instability.
After completion of study therapy, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 40 patients with WHO II grade 4 tumors (glioblastoma multiforme [GBM]) and 20 patients with WHO II grade 3 tumors (non-GBM) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temozolomide | Experimental | Drug: temozolomidesingle arm trial; Patients treated with temozolomide at a dose of 150mg/m2 daily for seven consecutive days of every other week. One 28-day cycle will include treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with radiographically proven recurrent, intracranial malignant glioma will be eligible for this protocol.
- All patients must sign an informed consent
- Patients must have had external beam radiation; there is no limit to the number of prior chemotherapies used.
- Patients must be > 18 years old, and with a life expectancy > 8 weeks.
- Patients must have a Karnofsky performance status of > 60.
Key exclusion criteria (4 listed)
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
- Patients must not have active infection or serious intercurrent medical illness.
- Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.
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: temodarsingle arm study | Drug | Temozolomide |
Primary outcome
6 Month Progression-free Survival
Time frame: First day of treatment until progression or until 6 months mark
Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival
6 secondary outcomes
Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.
Time frame: First day of treatment until progression or until 6 months mark
Overall Survival
Time frame: up to 2 years after treatment
Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System
Time frame: prior to start of study
Patients Progressing After Two First-line Adjuvant Courses of Temozolomide
Time frame: After two first-line adjuvant courses of temozolomide
Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide
Time frame: Within 6 months after 6th adjuvant course of temozolomide
Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued
Time frame: From beginning of voluntarily temozolomide discontinued up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24670608Han SJ, Rolston JD, Molinaro AM, Clarke JL, Prados MD, Chang SM, Berger MS, DeSilva A, Butowski NA. Phase II trial of 7 days on/7 days off temozolmide for recurrent high-grade glioma. Neuro Oncol. 2014 Sep;16(9):1255-62. doi: 10.1093/neuonc/nou044. Epub 2014 Mar 26.
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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.
Nicholas A. Butowski, MD principal investigator
University of California, San Francisco
Susan M. Chang, MD principal investigator
University of California, San Francisco
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 temozolomide in people with Recurrent Central Nervous System Neoplasm, run by University of California, San Francisco 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 12 inclusion and 4 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 31 Jan 2018. 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 29 Oct 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?
6 Month Progression-free Survival (time frame: First day of treatment until progression or until 6 months mark). 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 NCT00619112, 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 31 Jan 2018.