Glioblastoma MultiformePhase 2NCT00038493
Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
A Phase 2 study testing Temozolomide and SCH66336 in people with Glioblastoma Multiforme, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study will combine the chemotherapy agent temozolomide with the investigational drug SCH66336 (an agent which interferes with new cell growth). Patients will be treated with oral temozolomide on days 1-5 and oral SCH66336 on days 8-28 every 28 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Temozolomide and SCH66336
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2001to 1 Aug 2005
- Phase
- Phase 2
- 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 histologically proven supratentorial glioblastoma multiforme (GBM).
- Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI scan after radiation therapy. The scan done prior to study entry documenting progression will be reviewed by the primary investigator to document tumor volume changes to provide a gross assessment of growth rate.
- Patients may have had: a) no prior chemotherapy, b) 1 prior adjuvant chemotherapy, c) 1 prior adjuvant chemotherapy followed by 1 regimen for recurrent disease, or d) 1 or 2 prior chemotherapy regimens for recurrent or progressive tumor.
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.
- Patients must have shown unequivocal evidence for tumor progression by MRI or CT scan. A scan should be performed within 14 days prior to registration and on a steroid dose that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement.
- Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
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- They have recovered from the effects of surgery.
- Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration. If the 96-hour scan is more than 14 days before registration, the scan needs to be repeated. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days.
- Patients must be > 18 years old, and with life expectancy > 8 weeks.
- Patients must have a Karnofsky performance status of > 60 (Karnofsky Performance Scale; Appendix C).
- Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair.
- Patients must have adequate bone marrow function (ANC> 1,500/mm3 and platelet count of > 100,000/mm3), adequate liver function (SGPT and alkaline phosphatase <2 times normal, bilirubin <1.5 mg%), and adequate renal function (BUN and creatinine <1.5 times institutional normal) prior to starting therapy.
- Patients must have a normal QT interval on an EKG done within 2 weeks prior to study entry.
- Patients must not be taking primidone, carbamazepine, phenobarbital or phenytoin anticonvulsants. Patients changing from these anticonvulsants to others that are allowed must be off the drugs listed above for at least 72 hours.
- 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
- disease that will obscure toxicity or dangerously alter drug metabolism
- serious intercurrent medical illness.
- prior recurrence with either Temozolomide or a farnesyl transferase inhibitor
- oral contraceptives and other hormonal methods (Depo-Provera) of birth control.
- Patients must not be pregnant and both male and female patients must practice adequate contraception.
Who cannot join
- 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 with the following are ineligible:
- active infection
- pregnancy and must practice adequate contraception
- disease that will obscure toxicity or dangerously alter drug metabolism
- serious intercurrent medical illness
- previous treatment with either Temozolomide or a farnesyl transferase inhibitor
- oral contraceptives and other hormonal methods (Depo-Provera) of birth control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Evaluation Temozolomide and Farnesyl Transferase Inhibitor (SCH66336) for the Treatment of Recurrent and Progressive Glioblastoma Multiforme
This study will combine the chemotherapy agent temozolomide with the investigational drug SCH66336 (an agent which interferes with new cell growth). Patients will be treated with oral temozolomide on days 1-5 and oral SCH66336 on days 8-28 every 28 days.
Read the detailed description
Temozolomide at a dose of, 150-200 mg/m2, will be administered orally, after fasting for one hour, once a day for 5 consecutive days (days 1 through 5) every 4 weeks (plus up to 3 days). The starting dose level of 200 mg/m2 will be used for patients who have not previously received any chemotherapy or at 150 mg/m2 for patients who have received previous chemotherapy.
SCH66336 will be given orally, with water, in the morning and in the evening for three weeks (Days 8 - 28) every 28 days (plus up to 3 days) 1 hour before or after morning and evening meals. Patients will take 150 mg in the morning and 150 mg in the evening.
Treatment courses may be repeated every 28 days following the first daily dose of Temozolomide for the previous course.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Temozolomide and SCH66336
- Keywords
- GBM, Glioma, Brain Tumor
- Medical subject headings
- Glioblastoma, Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temozolomide and SCH66336Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2002 (estimated)
- Study start21 Sep 2001
- Primary completion1 Aug 2005
- Study completion1 Aug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038493
- Sponsor's protocol ID
- DM01-258
- Status last verified
- Oct 2018
- First submitted
- 31 May 2002
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation Temozolomide and Farnesyl Transferase Inhibitor (SCH66336) for the Treatment of Recurrent and Progressive Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00038493
- Acronym / sponsor ID
- DM01-258
- Conditions
- Glioblastoma Multiforme
- Keywords
- GBM, Glioma, Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Sep 2001 (actual)
- Primary completion
- 1 Aug 2005 (actual)
- Study completion
- 1 Aug 2005 (actual)
- First posted
- 3 Jun 2002 (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 study will combine the chemotherapy agent temozolomide with the investigational drug SCH66336 (an agent which interferes with new cell growth). Patients will be treated with oral temozolomide on days 1-5 and oral SCH66336 on days 8-28 every 28 days.
Detailed description
Temozolomide at a dose of, 150-200 mg/m2, will be administered orally, after fasting for one hour, once a day for 5 consecutive days (days 1 through 5) every 4 weeks (plus up to 3 days). The starting dose level of 200 mg/m2 will be used for patients who have not previously received any chemotherapy or at 150 mg/m2 for patients who have received previous chemotherapy.
SCH66336 will be given orally, with water, in the morning and in the evening for three weeks (Days 8 - 28) every 28 days (plus up to 3 days) 1 hour before or after morning and evening meals. Patients will take 150 mg in the morning and 150 mg in the evening.
Treatment courses may be repeated every 28 days following the first daily dose of Temozolomide for the previous course.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients with histologically proven supratentorial glioblastoma multiforme (GBM).
- Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI scan after radiation therapy. The scan done prior to study entry documenting progression will be reviewed by the primary investigator to document tumor volume changes to provide a gross assessment of growth rate.
- Patients may have had: a) no prior chemotherapy, b) 1 prior adjuvant chemotherapy, c) 1 prior adjuvant chemotherapy followed by 1 regimen for recurrent disease, or d) 1 or 2 prior chemotherapy regimens for recurrent or progressive tumor.
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.
- Patients must have shown unequivocal evidence for tumor progression by MRI or CT scan. A scan should be performed within 14 days prior to registration and on a steroid dose that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement.
Key exclusion criteria (8 listed)
- 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 with the following are ineligible:
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 |
|---|---|---|
| Temozolomide and SCH66336 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and SCH66336 in people with Glioblastoma Multiforme, run by M.D. Anderson Cancer Center 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 22 inclusion and 8 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 29 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 29 Oct 2018.