Glioblastoma MultiformePhase 2NCT00412542
Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas
A Phase 2 study testing Thalidomide, CPT-11 and MRI Scan in people with Glioblastoma Multiforme and Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: 1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma Multiforme, Glioma
- What is being tested?
- Thalidomide, CPT-11 and MRI Scan
- 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
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically proven supratentorial malignant primary gliomas (Glioblastoma multiforme (GBM), Gliosarcoma (GS) Anaplastic astrocytoma (AA), Anaplastic oligodendroglioma (AO), mixed anaplastic glioma (MAG)) will be eligible for this protocol.
- Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI scan after radiation therapy.
- Patients in the GBM stratum may have had treatment for no more than 2 prior relapses; for the AA stratum, there is no limitation for the number of relapses provided all other eligibility criteria particularly the functional status are met.
- All patients must sign an informed consent.
- The baseline on-study MRI should be performed within 14 days prior to registration and on a stable or decreasing steroid dosage.
- Patients having undergone recent resection of recurrent or progressive tumor will be eligible.
Show all 11Show fewer
- Patients must have a life expectancy > 8 weeks.
- Patients must have a Karnofsky performance status of >= 70
- 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, cis-retinoic acid, etc. (radiosensitizer does not count). Patients who receive either Temozolomide or CPT-11 for non-therapeutic purposes (such as presurgically for obtaining pharmacology data for the agent) will be eligible for study entry provided they have recovered from the toxic effects of the agent if any.
- Patients must have adequate bone marrow function (Absolute neutrophil count (ANC)> 1,500/mm3 and platelet count of > 100,000/mm3), adequate liver function (alanine aminotransferase (ALT or SGPT) and alkaline phosphatase <2 times normal, bilirubin <1.5 mg/dl), and adequate renal function (blood urea nitrogen (BUN) and creatinine <1.5 times institutional normal) prior to starting therapy.
- Patients must not be pregnant and must practice adequate contraception during the study and for 2 months after participation in study.
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 must not have: a) active infection b) disease that will obscure toxicity or dangerously alter drug metabolism c) serious intercurrent medical illness. d) prior recurrence with CPT-11 (for the CPT-11 + Thalidomide arm) (prior treatment with thalidomide is permitted). e) grade 2 or higher peripheral neuropathy. Patients who have received Temozolomide or CPT-11 for non-therapeutic purposes (for eg., as part of a pharmacology study without therapeutic intent) will remain eligible for enrollment into the study.
- No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows: American Indian or Alaskan Native - 0 Asian or Pacific Islander - <2% Black, not of Hispanic Origin - 3% Hispanic - 6% White, not of Hispanic Origin - 88% Other or Unknown - 2% Total-100%
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme
Objectives:
1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas.
1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11.
1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.
1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.
Read the detailed description
Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that was designed to stop cancer cells from dividing.
All participants will take thalidomide capsules by mouth every evening at bedtime. You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week. After that, you will increase the dose to 4 capsules each night for the rest of the study. The dosages may be adjusted if you experience any severe side effects.
In addition to thalidomide, you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug. This 6 week period is called a course of therapy. The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years.
THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs is investigational.
Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Glioblastoma Multiforme, Glioma
- Being tested
- Thalidomide, CPT-11, MRI Scan, Quantitative Sensory Tests (QST)
- Keywords
- Glioblastoma Multiforme, Glioma, Thalidomide, Thalomid, CPT-11, Irinotecan, malignant glioma
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Also called Thalomid
100 mg PO (by mouth) daily for 8 weeks
CPT-11Drug
Also called Irinotecan
125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest
MRI ScanProcedure or surgery
Also called Magnetic Resonance Imaging, MR
Dynamic MRI scan with dye injection through vein, every 6 weeks
Quantitative Sensory Tests (QST)Procedure or surgery
QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide + CPT-11 | Experimental | Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest. Receives: Drug: Thalidomide; Drug: CPT-11; Procedure: MRI Scan; Procedure: Quantitative Sensory Tests (QST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Progression Free at 6 Months With Malignant Gliomas
Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startOct 2003
- Primary completionOct 2009
- Study completionOct 2009
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Vinay K. Puduvalli, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412542
- Sponsor's protocol ID
- DM02-595
- Status last verified
- Feb 2012
- First submitted
- 15 Dec 2006
- Last updated
- 28 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00412542
- Acronym / sponsor ID
- DM02-595
- Conditions
- Glioblastoma Multiforme, Glioma
- Keywords
- Glioblastoma Multiforme, Glioma, Thalidomide, Thalomid, CPT-11, Irinotecan, malignant glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Oct 2003
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Dec 2006 (estimated)
- Results
- Posted 28 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas.
1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11.
1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.
1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.
Detailed description
Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that was designed to stop cancer cells from dividing.
All participants will take thalidomide capsules by mouth every evening at bedtime. You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week. After that, you will increase the dose to 4 capsules each night for the rest of the study. The dosages may be adjusted if you experience any severe side effects.
In addition to thalidomide, you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug. This 6 week period is called a course of therapy. The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years.
THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs is investigational.
Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide + CPT-11 | Experimental | Drug: Thalidomide, Drug: CPT-11, Procedure: MRI Scan, Procedure: Quantitative Sensory Tests (QST)Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically proven supratentorial malignant primary gliomas (Glioblastoma multiforme (GBM), Gliosarcoma (GS) Anaplastic astrocytoma (AA), Anaplastic oligodendroglioma (AO), mixed anaplastic glioma (MAG)) will be eligible for this protocol.
- Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI scan after radiation therapy.
- Patients in the GBM stratum may have had treatment for no more than 2 prior relapses; for the AA stratum, there is no limitation for the number of relapses provided all other eligibility criteria particularly the functional status are met.
- All patients must sign an informed consent.
- The baseline on-study MRI should be performed within 14 days prior to registration and on a stable or decreasing steroid dosage.
Key exclusion criteria (3 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 must not have: a) active infection b) disease that will obscure toxicity or dangerously alter drug metabolism c) serious intercurrent medical illness. d) prior recurrence with CPT-11 (for the CPT-11 + Thalidomide arm) (prior treatment with thalidomide is permitted). e) grade 2 or higher peripheral neuropathy. Patients who have received Temozolomide or CPT-11 for non-therapeutic purposes (for eg., as part of a pharmacology study without therapeutic intent) will remain eligible for enrollment into the study.
- No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows: American Indian or Alaskan Native - 0 Asian or Pacific Islander - <2% Black, not of Hispanic Origin - 3% Hispanic - 6% White, not of Hispanic Origin - 88% Other or Unknown - 2% Total-100%
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 |
|---|---|---|
| ThalidomideAlso: Thalomid100 mg PO (by mouth) daily for 8 weeks | Drug | Thalidomide + CPT-11 |
| CPT-11Also: Irinotecan125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest | Drug | Thalidomide + CPT-11 |
| MRI ScanAlso: Magnetic Resonance Imaging, MRDynamic MRI scan with dye injection through vein, every 6 weeks | Procedure or surgery | Thalidomide + CPT-11 |
| Quantitative Sensory Tests (QST)QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature. | Procedure or surgery | Thalidomide + CPT-11 |
Primary outcome
Number of Participants Progression Free at 6 Months With Malignant Gliomas
Time frame: 6 Months
Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas M.D.Anderson Cancer CenterLink 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.
Vinay K. Puduvalli, MD principal investigator
M.D. Anderson Cancer Center
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 Thalidomide, CPT-11 and MRI Scan in people with Glioblastoma Multiforme and Glioma, 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 11 inclusion and 3 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 28 Feb 2012. 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 28 Feb 2012). 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 Participants Progression Free at 6 Months With Malignant Gliomas (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 28 Feb 2012.