Brain MetastasesPhase 1NCT00879073
Study Bendamustine Concurrent Whole Brain Radiation Brain Metastases From Solid Tumors
A Phase 1 study testing Bendamustine in people with Brain Metastases, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to: Test the maximum tolerated dose (MTD) of Bendamustine with whole brain radiation therapy (WBRT) To determine the plasma pharmacokinetics (a blood test to see how much of the drug is getting into the patient's system and how long it lasts in the system) of Bendamustine To determine the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2012
- Phase
- Phase 1
- 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
- Pathologically (histologically or cytologically) proven diagnosis of solid tumor malignancy within 5 years of registration. Pathological confirmation by pathologists at Moffitt Cancer Center is required.
- Cerebral metastases from known solid tumors diagnosed by contrast-enhanced brain magnetic resonance imaging (MRI) or contrast-enhanced head computed tomography (CT) for patients unable to receive MRIs
- Single metastases that have been resected
- Patient may have had prior radiosurgery or surgical resection for brain metastasis. Patients should have completed prior therapy at least 14 days but no longer than 56 days prior to study entry.
- Karnofsky Performance Status ≥ 70 within 28 days prior to study entry.
- Expected life span of ≥ 3 months
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- Able to tolerate 3 week course of whole brain radiation therapy
- Able to receive a lumbar puncture (for post-MTD patients only)
- Adequate bone marrow, liver and renal function as assessed by the following: Hemoglobin > 9.0 g/dl; Absolute neutrophil count (ANC) > 1,500/mm³; Platelet count > 100,000/mm³; Total bilirubin < 1.5 x upper limit of normal (ULN); Alanine transaminase/Aspartic transaminase (ALT/AST) < 2.5 x the ULN (< 5 x ULN for patients with liver involvement); International normalized ratio (INR) < 1.5 or a prothrombin time/partial thromboplastin time (PT/PTT) within normal limits; Creatinine < 1.5 x ULN
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
- Ability to understand and sign a study-specific written informed consent prior to study entry.
- Patients receiving systemic therapy are eligible for this study if given >14 days prior to study entry and given no sooner than >14 days post radiation therapy (RT) completion.
- Complete history and general physical examination within 28 days prior to study entry
Who cannot join
- Known hypersensitivity to bendamustine or mannitol
- Patients with cerebral metastases from unknown primary tumors
- Patients with cerebral metastases from leukemias or lymphomas
- Patients with uncontrolled systemic cancer (i.e. evidence of systemic disease progression < 3 months prior to study entry)
- Systemic chemotherapy ≤14 days prior to study entry or ≤14 days after completing radiotherapy
- Patients who received prior BCNU wafer (Gliadel®) implantation for surgically resected cerebral metastatic lesions
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- Patients with a life expectancy of less than 3 months
- Patients who received prior whole brain radiation therapy. As noted above, patients who received prior radiosurgery are allowed
- Patients with significant hydrocephalous
- Active clinically serious infection > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase I Study of Bendamustine With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors
The purpose of this study is to:
- Test the maximum tolerated dose (MTD) of Bendamustine with whole brain radiation therapy (WBRT)
- To determine the plasma pharmacokinetics (a blood test to see how much of the drug is getting into the patient's system and how long it lasts in the system) of Bendamustine
- To determine the presence of Bendamustine in cerebrospinal fluid (CSF) (fluid from the brain and spinal cord) of study patients Bendamustine is approved by the Food and Drug Administration (FDA) for chronic lymphocytic leukemia. However, Bendamustine will be used in this study as an investigational agent.
Read the detailed description
Bendamustine will be started in the first group at a dose of 60 mg/m²; patients in group 2 will be given Bendamustine at a dose of 80 mg/m²; patients in Group 3 will be given Bendamustine at 100 mg/m². Each cohort will receive Bendamustine once weekly for a total of 4 weeks.
Approximately 3-6 patients enrolled in this study will receive lumbar punctures. Patients will be told before study enrollment whether they will have a lumbar puncture to withdraw CSF.
- Conditions
- Brain Metastases
- Being tested
- Bendamustine
- Keywords
- Brain and Nervous System
- Medical subject headings
- Brain Neoplasms, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Treanda
Approximately 15-24 study patients will be enrolled in this Phase I trial. Study patients will receive a weekly dose of IV bendamustine with whole brain radiation therapy for 3 weeks and then receive a fourth dose of IV bendamustine one week after completion of whole brain radiation therapy. The first dose of IV bendamustine will be given when whole brain radiation is initiated.
| Study group | Role | What they receive |
|---|---|---|
| A - Cohort 1 Treatment | Experimental | Cohort 1: Bendamustine 60 mg/m² x 4 weeks Receives: Drug: Bendamustine |
| B - Cohort 2 Treatment | Experimental | Cohort 2: Bendamustine 80 mg/m² x 4 weeks Receives: Drug: Bendamustine |
| C - Cohort 3 Treatment | Experimental | Cohort 3: Bendamustine 100 mg/m² x 4 weeks Receives: Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
To determine the MTD of bendamustine in combination with WBRT
Measured: 24 Weeks per Patient
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs)
To determine the toxicity profile of bendamustine in combination with WBRT
Measured: 24 Weeks per Patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2012
- Study completionDec 2012
Why it stopped: Principal Investigator is leaving Moffitt
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Cephalon
- Responsible party
- Sponsor
- Investigators
- Edward Pan, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879073
- Sponsor's protocol ID
- MCC-15690
- Status last verified
- Dec 2012
- First submitted
- 8 Apr 2009
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Bendamustine With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors
- ClinicalTrials.gov ID
- NCT00879073
- Acronym / sponsor ID
- MCC-15690
- Conditions
- Brain Metastases
- Keywords
- Brain and Nervous System
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator is leaving Moffitt
- Enrolment
- 12 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Cephalon
- Study start
- Apr 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Apr 2009 (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.
The purpose of this study is to:
- Test the maximum tolerated dose (MTD) of Bendamustine with whole brain radiation therapy (WBRT)
- To determine the plasma pharmacokinetics (a blood test to see how much of the drug is getting into the patient's system and how long it lasts in the system) of Bendamustine
- To determine the presence of Bendamustine in cerebrospinal fluid (CSF) (fluid from the brain and spinal cord) of study patients Bendamustine is approved by the Food and Drug Administration (FDA) for chronic lymphocytic leukemia. However, Bendamustine will be used in this study as an investigational agent.
Detailed description
Bendamustine will be started in the first group at a dose of 60 mg/m²; patients in group 2 will be given Bendamustine at a dose of 80 mg/m²; patients in Group 3 will be given Bendamustine at 100 mg/m². Each cohort will receive Bendamustine once weekly for a total of 4 weeks.
Approximately 3-6 patients enrolled in this study will receive lumbar punctures. Patients will be told before study enrollment whether they will have a lumbar puncture to withdraw CSF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - Cohort 1 Treatment | Experimental | Drug: BendamustineCohort 1: Bendamustine 60 mg/m² x 4 weeks |
| B - Cohort 2 Treatment | Experimental | Drug: BendamustineCohort 2: Bendamustine 80 mg/m² x 4 weeks |
| C - Cohort 3 Treatment | Experimental | Drug: BendamustineCohort 3: Bendamustine 100 mg/m² x 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologically (histologically or cytologically) proven diagnosis of solid tumor malignancy within 5 years of registration. Pathological confirmation by pathologists at Moffitt Cancer Center is required.
- Cerebral metastases from known solid tumors diagnosed by contrast-enhanced brain magnetic resonance imaging (MRI) or contrast-enhanced head computed tomography (CT) for patients unable to receive MRIs
- Single metastases that have been resected
- Patient may have had prior radiosurgery or surgical resection for brain metastasis. Patients should have completed prior therapy at least 14 days but no longer than 56 days prior to study entry.
- Karnofsky Performance Status ≥ 70 within 28 days prior to study entry.
Key exclusion criteria (11 listed)
- Known hypersensitivity to bendamustine or mannitol
- Patients with cerebral metastases from unknown primary tumors
- Patients with cerebral metastases from leukemias or lymphomas
- Patients with uncontrolled systemic cancer (i.e. evidence of systemic disease progression < 3 months prior to study entry)
- Systemic chemotherapy ≤14 days prior to study entry or ≤14 days after completing radiotherapy
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 |
|---|---|---|
| BendamustineAlso: TreandaApproximately 15-24 study patients will be enrolled in this Phase I trial. Study patients will receive a weekly dose of IV bendamustine with whole brain radiation therapy for 3 weeks and then receive a fourth dose of IV bendamustine one week after completion of whole brain radiation therapy. The first dose of IV bendamustine will be given when whole brain radiation is initiated. | Drug | A - Cohort 1 Treatment, B - Cohort 2 Treatment, C - Cohort 3 Treatment |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 24 Weeks per Patient
To determine the MTD of bendamustine in combination with WBRT
1 secondary outcome
Number of Participants With Adverse Events (AEs)
Time frame: 24 Weeks per Patient
Results and safety
The study was stopped early (reason given: Principal Investigator is leaving Moffitt). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
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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.
Edward Pan, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bendamustine in people with Brain Metastases, run by H. Lee Moffitt Cancer Center and Research Institute 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 13 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 Dec 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Principal Investigator is leaving Moffitt). Results are not available in the source record.
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?
Maximum Tolerated Dose (MTD) (time frame: 24 Weeks per Patient). 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 18 Dec 2012.