GliomaPhase 2NCT00108069
Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors
A Phase 2 study testing Tamoxifen citrate and Bortezomib in people with Glioma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with tumor growth processes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Tamoxifen citrate and Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Mar 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
- Patients with histologically proven high-grade gliomas or patients with a clinical and radiographic diagnosis of brainstem glioma will be eligible for this protocol. High-grade gliomas include glioblastoma multiforme (GBM; stratum 1) and its variants such as gliosarcoma and anaplastic gliomas (AG; stratum 2), such as anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma/glioma NOS (not otherwise specified).
- Patients must have unequivocal evidence for tumor progression by magnetic resonance imaging (MRI) or computerized tomography (CT) scan. This scan should be performed within 14 days prior to registration and on a steroid dosage 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:
- They have recovered from the effects of surgery.
- Residual disease following resection of recurrent tumor is 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
Show all 19Show fewer
- at least 4 weeks post-operatively, and
- within 14 days of registration, and
- on a steroid dosage that has been stable for at least 5 days.
- If the 96 hour scan is more than 21 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 have failed prior radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry.
- Ability of subjects or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
- Patients must be greater than or equal to 18 years old, and with a life expectancy greater than 8 weeks.
- Patients must have a Karnofsky performance status of greater than or equal to 60.
- Patients must have recovered from the toxic effects of prior therapy: 2 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy, two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, 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 (white blood cell (WBC) greater than or equal to 3,000/microl, absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, platelet count of greater than or equal to 100,000/mm^3, and hemoglobin greater than or equal to 10 gm/dl), adequate liver function (serum glutamic oxaloacetic transaminase (SGOT) and bilirubin less than 2 times ULN), and adequate renal function (creatinine less than 1.5 mg/dL and/or creatinine clearance greater than or equal to 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion.
- 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 patients' ability to tolerate this therapy.
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate.
- Patients must practice adequate contraception.
Who cannot join
- Patients who, in the view of the treating physician, have significant active cardiac (documented coronary artery disease, congestive heart failure, arrhythmia requiring medication), hepatic (hepatocellular and/or cholestatic dysfunction as documented by liver biopsy, liver ultrasound, or abnormal liver function blood tests, renal (as documented by renal biopsy, ultrasound, CT/MRI scans or reflected in the blood tests or psychiatric diseases (requiring hospitalization or is of significant severity to impair the patients ability to cooperate with the study instructions).
- No concurrent use of other standard chemotherapeutics or investigative agents.
- Patients known to have an active malignancy other than their glioma (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
- Patients who have an active infection requiring intravenous (IV) antibiotics.
- Patients who are pregnant or breast feeding.
- Patients who have any disease that will obscure toxicity or dangerously alter drug metabolism.
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- Patients who have had clear tumor progression while being treated with tamoxifen and/or patients treated with tamoxifen within the past year.
- Patients who are taking EIAEDs (enzyme inducing anti-epileptic drugs) are not eligible.
- Patients who have had documented tumor progression while taking tamoxifen and/or any treatment with tamoxifen within 6 months of registration.
- Salicylates ARE permitted.
- Patients with grade 2 or greater peripheral neuropathy.
- Invasive procedures defined as follows:
- Major surgical procedures, open biopsy or significant traumatic injury within 28 days prior to Day ! therapy
- Anticipation of need for major surgical procedures during the course of the study
- Core biopsy within 7 days prior to D1 therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Trial of Tamoxifen and Bortezomib in Patients With Recurrent High-Grade Gliomas
This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with tumor growth processes. Laboratory studies show that low doses of bortezomib significantly enhance glioma cell death when used with tamoxifen.
Patients 18 years of age and older with glioma whose tumor does not respond to standard medical treatment and who are not taking enzyme-inducing anti-seizure medications such as Dilantin, phenobarbitol, or Tegretol, may be eligible for this study. Candidates are screened with a physical examination, blood tests, and magnetic resonance imaging (MRI) or computed tomography (CT). MRI and CT scans produce images of the brain that can show if the brain tumor is growing (see below).
Read more
Participants receive treatment in 6-week cycles for up to 1 year. (The treatment duration may be extended in some patients who continue to tolerate the drug and show no signs of tumor growth after 1 year.) During each cycle, patients take six tamoxifen tablets twice a day every day and receive bortezomib by infusion into a vein on days 3, 6, 10, 13, 24, 27, 31 and 34. Treatment may continue as long as the tumor does not grow and the patient does not develop unacceptable side effects. In addition to drug treatment, patients undergo the following tests and procedures:
- Periodic routine blood tests.
- MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. CT uses x-rays to provide 3-dimensional views of the part of the body being studied. For both procedures, the patient lies on a table that slides into the cylindrical scanner.
- Blood test to measure levels of bortezomib. Blood is drawn before the bortezomib infusion on days 3 and 24, and 4 hours after the infusion on day 24 of the first treatment cycle only.
- Dynamic MRI with spectroscopy or positron emission tomography (PET). Patients may be asked to undergo one of these tests, which help distinguish live tumor from dying tumor. The experience of dynamic MRI with spectroscopy is the same as standard MRI and is done at the same time as the standard procedure (see above). PET uses a radioactive substance to show cellular activity in specific tissues of the body. The patient is given an injection of a sugar solution in which a radioactive isotope has been attached to the sugar molecule. A special camera detects the radiation emitted by the radioisotope, and the resulting images show how much glucose is being used in various parts of the body. Because rapidly growing cells, such as tumors, take up and use more glucose than normal cells do, this test can be used to show active tumors.
- Drug diary. Patients maintain a calendar to record when they take their study drugs and what side effects they develop.
Read the detailed description
Background:
Tamoxifen (TAM), a member of the selective estrogen receptor modulator (SERM) family, is widely used in the treatment of estrogen receptor (ER) expressing breast cancer. It has previously been shown that high-dose TAM has cytotoxic activity against glioma cells, but whether this effect is drug-specific or represents a general property of SERMs was unknown. We have now demonstrated that suppression of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activation markedly enhances SERM-induced apoptosis, suggesting a role for NF-kB in protecting glioma cells from SERM-induced cytotoxicity.
Bortezomib is a potent inhibitor of the 26S proteosome and causes significant anti-proliferative and cytotoxic effects in a number of cell lines through its protean effects on a variety of cellular signaling pathways, including its ability to potently inhibit the NF-kB pathway. We have recently demonstrated that bortezomib has significant anti-glioma activity in vitro and a ongoing clinical trial has demonstrated some possible activity in patients with recurrent gliomas. We have now also generated preclinical data demonstrating that bortezomib in combination with Tamoxifen has synergistic cytotoxic effects on glioma cells.
Thus, given the minimal to modest activity of both drugs in patients with recurrent gliomas, given their spectrum of non-overlapping toxicities, and given the marked synergistic glioma cell killing of the combination of drugs in our preclinical screens, we are now proposing a phase II trial of bortezomib in combination with Tamoxifen in patients with recurrent gliomas not taking enzyme inducing anti-epileptic drugs (EIAEDs).
Objectives:
The primary statistical endpoint will be response (defined as either stable disease or objective response as is standard in neuro-oncology clinical trials) after 6 weeks of treatment.
Eligibility:
Patients with histologically proven high-grade gliomas or patients with a clinical and radiographic diagnosis of brainstem glioma will be eligible for this protocol.
Design:
The phase II study will be stratified by the type of high grade glioma (anaplastic glioma (AA) or glioblastoma (GBM)) and a two-stage min-max design with a maximum of 41 patients in the GBM stratum and 36 patients in the AA stratum.
- Conditions
- Glioma
- Being tested
- Tamoxifen citrate, Bortezomib
- Keywords
- Brain, Tumor, Malignant, Therapy, Progression, Chemotherapy, Antiangiogenesis, Radiation, Malignant Brain Tumor, Malignant Glioma, Glioma
- Medical subject headings
- Glioma, Neoplasms, Disease Progression, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen citrateDrug
Also called Nolvadex
oral dose 120 mg twice a day, every day
BortezomibDrug
Also called Velcade
intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle
| Study group | Role | What they receive |
|---|---|---|
| GBM (Glioblastoma multiforme) | Experimental | Not described Receives: Drug: Tamoxifen citrate; Drug: Bortezomib |
| AG (Anaplastic glioma) | Experimental | Not described Receives: Drug: Tamoxifen citrate; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response, Defined as Stable Disease or Objective (Partial or Complete) Response.
Complete response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. All measurable, evaluable and non-evaluable lesions and site must be assessed using the same techniques as baseline. Patients who respond must be on the same or decreasing doses of dexamethasone. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using same techniques as baseline. Responders must be on the same decreasing doses of dexamethasone. Stable disease (SD) does not qualify for CR, PR, or progression (e.g., a 25% increase in the sum of products of all measurable lesions). The designation of stable/no response requires a minimum of 6 weeks duration. All measurable and evaluable sites must be assessed using the same techniques as baseline.
Measured: Patients were followed for an average of six weeks for assessment of response
Secondary outcomes (2)
Number of Participants With Adverse Events
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Measured: 7.5 years
Adverse Event Grades
The combined serious and non-serious adverse event Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs for the GBM (Glioblastoma multiforme) and AG (Anaplastic glioma) cohorts.
Measured: 7.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionMar 2013
- Study completionMar 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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Katherine E. Warren, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Katherine Warren, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108069
- Sponsor's protocol ID
- 050137
- Other IDs
- 05-C-0137
- Status last verified
- Oct 2015
- First submitted
- 12 Apr 2005
- Last updated
- 5 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Barker D, Wright E, Nguyen K, Cannon L, Fain P, Goldgar D, Bishop DT, Carey J, Baty B, Kivlin J, et al. Gene for von Recklinghausen neurofibromatosis is in the pericentromeric region of chromosome 17. Science. 1987 May 29;236(4805):1100-2. doi: 10.1126/science.3107130.
PubMed 3107130Bigner SH, Bjerkvig R, Laerum OD. DNA content and chromosomal composition of malignant human gliomas. Neurol Clin. 1985 Nov;3(4):769-84.
PubMed 3001489Moss AR. Occupational exposure and brain tumors. J Toxicol Environ Health. 1985;16(5):703-11. doi: 10.1080/15287398509530780.
PubMed 4093991Odia Y, Kreisl TN, Aregawi D, Innis EK, Fine HA. A phase II trial of tamoxifen and bortezomib in patients with recurrent malignant gliomas. J Neurooncol. 2015 Oct;125(1):191-5. doi: 10.1007/s11060-015-1894-y. Epub 2015 Aug 19.
PubMed 26285768
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Tamoxifen and Bortezomib in Patients With Recurrent High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT00108069
- Acronym / sponsor ID
- 050137
- Conditions
- Glioma
- Keywords
- Brain, Tumor, Malignant, Therapy, Progression, Chemotherapy, Antiangiogenesis, Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2005
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Apr 2005 (estimated)
- Results
- Posted 12 Jun 2014
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 determine whether the drugs tamoxifen and bortezomib can delay tumor growth in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with tumor growth processes. Laboratory studies show that low doses of bortezomib significantly enhance glioma cell death when used with tamoxifen.
Patients 18 years of age and older with glioma whose tumor does not respond to standard medical treatment and who are not taking enzyme-inducing anti-seizure medications such as Dilantin, phenobarbitol, or Tegretol, may be eligible for this study. Candidates are screened with a physical examination, blood tests, and magnetic resonance imaging (MRI) or computed tomography (CT). MRI and CT scans produce images of the brain that can show if the brain tumor is growing (see below).
Participants receive treatment in 6-week cycles for up to 1 year. (The treatment duration may be extended in some patients who continue to tolerate the drug and show no signs of tumor growth after 1 year.) During each cycle, patients take six tamoxifen tablets twice a day every day and receive bortezomib by infusion into a vein on days 3, 6, 10, 13, 24, 27, 31 and 34. Treatment may continue as long as the tumor does not grow and the patient does not develop unacceptable side effects. In addition to drug treatment, patients undergo the following tests and procedures:
- Periodic routine blood tests.
- MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. CT uses x-rays to provide 3-dimensional views of the part of the body being studied. For both procedures, the patient lies on a table that slides into the cylindrical scanner.
- Blood test to measure levels of bortezomib. Blood is drawn before the bortezomib infusion on days 3 and 24, and 4 hours after the infusion on day 24 of the first treatment cycle only.
- Dynamic MRI with spectroscopy or positron emission tomography (PET). Patients may be asked to undergo one of these tests, which help distinguish live tumor from dying tumor. The experience of dynamic MRI with spectroscopy is the same as standard MRI and is done at the same time as the standard procedure (see above). PET uses a radioactive substance to show cellular activity in specific tissues of the body. The patient is given an injection of a sugar solution in which a radioactive isotope has been attached to the sugar molecule. A special camera detects the radiation emitted by the radioisotope, and the resulting images show how much glucose is being used in various parts of the body. Because rapidly growing cells, such as tumors, take up and use more glucose than normal cells do, this test can be used to show active tumors.
- Drug diary. Patients maintain a calendar to record when they take their study drugs and what side effects they develop.
Detailed description
Background:
Tamoxifen (TAM), a member of the selective estrogen receptor modulator (SERM) family, is widely used in the treatment of estrogen receptor (ER) expressing breast cancer. It has previously been shown that high-dose TAM has cytotoxic activity against glioma cells, but whether this effect is drug-specific or represents a general property of SERMs was unknown. We have now demonstrated that suppression of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activation markedly enhances SERM-induced apoptosis, suggesting a role for NF-kB in protecting glioma cells from SERM-induced cytotoxicity.
Bortezomib is a potent inhibitor of the 26S proteosome and causes significant anti-proliferative and cytotoxic effects in a number of cell lines through its protean effects on a variety of cellular signaling pathways, including its ability to potently inhibit the NF-kB pathway. We have recently demonstrated that bortezomib has significant anti-glioma activity in vitro and a ongoing clinical trial has demonstrated some possible activity in patients with recurrent gliomas. We have now also generated preclinical data demonstrating that bortezomib in combination with Tamoxifen has synergistic cytotoxic effects on glioma cells.
Thus, given the minimal to modest activity of both drugs in patients with recurrent gliomas, given their spectrum of non-overlapping toxicities, and given the marked synergistic glioma cell killing of the combination of drugs in our preclinical screens, we are now proposing a phase II trial of bortezomib in combination with Tamoxifen in patients with recurrent gliomas not taking enzyme inducing anti-epileptic drugs (EIAEDs).
Objectives:
The primary statistical endpoint will be response (defined as either stable disease or objective response as is standard in neuro-oncology clinical trials) after 6 weeks of treatment.
Eligibility:
Patients with histologically proven high-grade gliomas or patients with a clinical and radiographic diagnosis of brainstem glioma will be eligible for this protocol.
Design:
The phase II study will be stratified by the type of high grade glioma (anaplastic glioma (AA) or glioblastoma (GBM)) and a two-stage min-max design with a maximum of 41 patients in the GBM stratum and 36 patients in the AA stratum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBM (Glioblastoma multiforme) | Experimental | Drug: Tamoxifen citrate, Drug: Bortezomib |
| AG (Anaplastic glioma) | Experimental | Drug: Tamoxifen citrate, Drug: Bortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with histologically proven high-grade gliomas or patients with a clinical and radiographic diagnosis of brainstem glioma will be eligible for this protocol. High-grade gliomas include glioblastoma multiforme (GBM; stratum 1) and its variants such as gliosarcoma and anaplastic gliomas (AG; stratum 2), such as anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma/glioma NOS (not otherwise specified).
- Patients must have unequivocal evidence for tumor progression by magnetic resonance imaging (MRI) or computerized tomography (CT) scan. This scan should be performed within 14 days prior to registration and on a steroid dosage 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:
- They have recovered from the effects of surgery.
- Residual disease following resection of recurrent tumor is mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a CT/ MRI should be done:
Key exclusion criteria (15 listed)
- Patients who, in the view of the treating physician, have significant active cardiac (documented coronary artery disease, congestive heart failure, arrhythmia requiring medication), hepatic (hepatocellular and/or cholestatic dysfunction as documented by liver biopsy, liver ultrasound, or abnormal liver function blood tests, renal (as documented by renal biopsy, ultrasound, CT/MRI scans or reflected in the blood tests or psychiatric diseases (requiring hospitalization or is of significant severity to impair the patients ability to cooperate with the study instructions).
- No concurrent use of other standard chemotherapeutics or investigative agents.
- Patients known to have an active malignancy other than their glioma (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
- Patients who have an active infection requiring intravenous (IV) antibiotics.
- Patients who are pregnant or breast feeding.
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 |
|---|---|---|
| Tamoxifen citrateAlso: Nolvadexoral dose 120 mg twice a day, every day | Drug | AG (Anaplastic glioma), GBM (Glioblastoma multiforme) |
| BortezomibAlso: Velcadeintravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle | Drug | AG (Anaplastic glioma), GBM (Glioblastoma multiforme) |
Primary outcome
Response, Defined as Stable Disease or Objective (Partial or Complete) Response.
Time frame: Patients were followed for an average of six weeks for assessment of response
Complete response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. All measurable, evaluable and non-evaluable lesions and site must be assessed using the same techniques as baseline. Patients who respond must be on the same or decreasing doses of dexamethasone. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using same techniques as baseline. Responders must be on the same decreasing doses of dexamethasone. Stable disease (SD) does not qualify for CR, PR, or progression (e.g., a 25% increase in the sum of products of all measurable lesions). The designation of stable/no response requires a minimum of 6 weeks duration. All measurable and evaluable sites must be assessed using the same techniques as baseline.
2 secondary outcomes
Number of Participants With Adverse Events
Time frame: 7.5 years
Adverse Event Grades
Time frame: 7.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3107130Barker D, Wright E, Nguyen K, Cannon L, Fain P, Goldgar D, Bishop DT, Carey J, Baty B, Kivlin J, et al. Gene for von Recklinghausen neurofibromatosis is in the pericentromeric region of chromosome 17. Science. 1987 May 29;236(4805):1100-2. doi: 10.1126/science.3107130.
- Background: PubMed 3001489Bigner SH, Bjerkvig R, Laerum OD. DNA content and chromosomal composition of malignant human gliomas. Neurol Clin. 1985 Nov;3(4):769-84.
- Background: PubMed 4093991Moss AR. Occupational exposure and brain tumors. J Toxicol Environ Health. 1985;16(5):703-11. doi: 10.1080/15287398509530780.
- Derived from this study: PubMed 26285768Odia Y, Kreisl TN, Aregawi D, Innis EK, Fine HA. A phase II trial of tamoxifen and bortezomib in patients with recurrent malignant gliomas. J Neurooncol. 2015 Oct;125(1):191-5. doi: 10.1007/s11060-015-1894-y. Epub 2015 Aug 19.
- NIH Clinical Center Detailed Web PageLink 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.
Katherine Warren, M.D. principal investigator
National Cancer Institute (NCI)
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 Tamoxifen citrate and Bortezomib in people with Glioma, run by National Cancer Institute (NCI) 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 19 inclusion and 15 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 5 Nov 2015. 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 12 Jun 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?
Response, Defined as Stable Disease or Objective (Partial or Complete) Response. (time frame: Patients were followed for an average of six weeks for assessment of response). 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 NCT00108069, which also lists 4 linked publications.
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 5 Nov 2015.