Metastatic CancerPhase 1NCT00837928
Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors
A Phase 1 study testing bendamustine, laboratory biomarker analysis and Surgical Resection of Brain Metastases in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by John Grecula at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- bendamustine, laboratory biomarker analysis and Surgical Resection of Brain Metastases
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2009to 8 Jan 2015
- 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
- Histologically confirmed cancer with 1 to 4 brain metastases imaged by MRI/CT scans not involving thalamus, basal ganglia or brain stem.
- No cancer originating in central nervous system
- Candidate for clinically indicated surgery to resect brain lesions.
- Karnofsky score of at least 60
- At least 18 years of age
- Life expectancy of more than two months
Who cannot join
- Evidence of leptomeningeal metastases.
- Need immediate treatment to prevent neurological deterioration.
- Prior brain radiotherapy or surgery for current brain metastases.
- Radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.
- Absolute neutrophil count (ANC)<1500/mm3 or platelets <50,000/mms.
- Brain metastasis diameter greater than 5 cm.
Show all 13Show fewer
- Not pregnant or nursing
- More than 3 weeks since prior chemotherapy.
- No evidence of ischemia on EKG and/or reduced cardiac ejection fraction (i.e., < 50%) on ECHO.
- No known sensitivity or allergy to bendamustine hydrochloride or mannitol
- No more than 3 prior cytotoxic chemotherapy regimens
- No unresolved persistent toxicities for 4 weeks from prior chemotherapy or 6 weeks for nitrosoureas.
- Calculated creatinine clearance <40 ml/min.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy of Patients With 1- 4 Brain Metastases From Solid Malignancies
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of bendamustine when given together with radiation therapy in treating patients with brain metastases caused by solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the recommended phase II dose of bendamustine hydrochloride when administered in combination with stereotactic radiotherapy for the treatment of patients with 1-4 brain metastases from solid malignancies.
Secondary
- Determine bendamustine hydrochloride pharmacokinetics and correlate this to bendamustine hydrochloride levels in brain metastases, brain margin, arachnoid, cerebral spinal fluid, and plasma acquired at the time of surgery.
- Assessment of local control of brain metastases.
OUTLINE: This is a dose-escalation study of bendamustine hydrochloride.
Patients with no potentially resectable lesion(s) receive bendamustine hydrochloride IV over 30 minutes and stereotactic radiotherapy once daily for 5 days.
Patients with potentially resectable lesion(s) receive bendamustine hydrochloride IV over 30 minutes on days 1-3 and undergo surgery on day 3. At least 4 weeks after surgery, these patients receive adjuvant bendamustine hydrochloride and stereotactic fractionated radiotherapy as above (in patients with no potentially resectable lesion[s])
Blood samples are collected periodically for pharmacokinetic studies. Cerebrospinal fluid, arachnoid, tumor margin, and tumor samples are also collected during surgery for correlative studies.
After completion of study treatment, patients are followed every 3 months for 21 months.
- Being tested
- bendamustine, laboratory biomarker analysis, Surgical Resection of Brain Metastases, Stereotactic body radiation therapy
- Keywords
- unspecified adult solid tumor, protocol specific, tumors metastatic to brain
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustineDrug
Also called Ribomustin, Treanda
40 mg/m2 will be administered IV on days 1,2,and 3 prior to surgery.on each day of SRT.
laboratory biomarker analysisOther
Also called Laboratory Procedure
samples will be obtained on day 1 or 2 only from patients undergoing surgery on day 3 (i.e. PK samples will not be collected from patients who begin SRT on day 1).
Surgical Resection of Brain MetastasesProcedure or surgery
Also called surgery
Surgical Resection of Brain Metastases Day 3 (immediately after Bendamustine)
Stereotactic body radiation therapyRadiation
Also called SRT, Stereotactic Fractionated Radiation Therapy
Starting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri)
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine and Fractionated stereotactic radiotherapy | Experimental | Bendamustine 40 mg/m2 and will be administered IV on days 1,2,and 3 prior to surgery on each day of SRT (Sterotactic radiation therapy). Laboratory biomarker analysis will be obtained on day 1 or 2 only from patients undergoing surgery on day 3 (i.e. Pharmacokinetic samples will not be collected from patients who begin SRT on day 1). Surgical Resection of Brain Metastases Day 3 (immediately after Bendamustine) Stereotactic fractionated radiation therapy starting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri). Concurrent Bendamustine is administered on Days of Stereotactic Radiotherapy (Arm 1: 40 mg/m2/ Day; Arm 2: 50 mg/m2/day). Receives: Drug: bendamustine; Other: laboratory biomarker analysis; Procedure: Surgical Resection of Brain Metastases; Radiation: Stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine recommended dose of Bendamustine when used in combination with Stereotactic Radiotherapy (STR) for treatment of patients with 1-4 brain metastases.
Measured: up to 4 years
Secondary outcomes (3)
Pharmacokinetics of bendamustine
Measured: up to 4 years
Levels of bendamustine hydrochloride in the brain metastases, brain margin, arachnoid, cerebral spinal fluid, and plasma
Measured: up to 4 years
Local control of brain metastases
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study start19 Feb 2009
- Primary completion8 Jan 2015
- Study completion8 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Grecula
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor-investigator, John Grecula, Ohio State University Comprehensive Cancer Center
- Investigators
- John C. Grecula, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837928
- Sponsor's protocol ID
- OSU-08142
- Other IDs
- NCI-2011-03179
- Status last verified
- May 2018
- First submitted
- 5 Feb 2009
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy of Patients With 1- 4 Brain Metastases From Solid Malignancies
- ClinicalTrials.gov ID
- NCT00837928
- Acronym / sponsor ID
- OSU-08142
- Keywords
- unspecified adult solid tumor, protocol specific, tumors metastatic to brain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- John GreculaUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 19 Feb 2009 (actual)
- Primary completion
- 8 Jan 2015 (actual)
- Study completion
- 8 Jan 2015 (actual)
- First posted
- 6 Feb 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.
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of bendamustine when given together with radiation therapy in treating patients with brain metastases caused by solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the recommended phase II dose of bendamustine hydrochloride when administered in combination with stereotactic radiotherapy for the treatment of patients with 1-4 brain metastases from solid malignancies.
Secondary
- Determine bendamustine hydrochloride pharmacokinetics and correlate this to bendamustine hydrochloride levels in brain metastases, brain margin, arachnoid, cerebral spinal fluid, and plasma acquired at the time of surgery.
- Assessment of local control of brain metastases.
OUTLINE: This is a dose-escalation study of bendamustine hydrochloride.
Patients with no potentially resectable lesion(s) receive bendamustine hydrochloride IV over 30 minutes and stereotactic radiotherapy once daily for 5 days.
Patients with potentially resectable lesion(s) receive bendamustine hydrochloride IV over 30 minutes on days 1-3 and undergo surgery on day 3. At least 4 weeks after surgery, these patients receive adjuvant bendamustine hydrochloride and stereotactic fractionated radiotherapy as above (in patients with no potentially resectable lesion[s])
Blood samples are collected periodically for pharmacokinetic studies. Cerebrospinal fluid, arachnoid, tumor margin, and tumor samples are also collected during surgery for correlative studies.
After completion of study treatment, patients are followed every 3 months for 21 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine and Fractionated stereotactic radiotherapy | Experimental | Drug: bendamustine, Other: laboratory biomarker analysis, Procedure: Surgical Resection of Brain Metastases, Radiation: Stereotactic body radiation therapyBendamustine 40 mg/m2 and will be administered IV on days 1,2,and 3 prior to surgery on each day of SRT (Sterotactic radiation therapy). Laboratory biomarker analysis will be obtained on day 1 or 2 only from patients undergoing surgery on day 3 (i.e. Pharmacokinetic samples will not be collected from patients who begin SRT on day 1). Surgical Resection of Brain Metastases Day 3 (immediately after Bendamustine) Stereotactic fractionated radiation therapy starting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri). Concurrent Bendamustine is administered on Days of Stereotactic Radiotherapy (Arm 1: 40 mg/m2/ Day; Arm 2: 50 mg/m2/day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed cancer with 1 to 4 brain metastases imaged by MRI/CT scans not involving thalamus, basal ganglia or brain stem.
- No cancer originating in central nervous system
- Candidate for clinically indicated surgery to resect brain lesions.
- Karnofsky score of at least 60
- At least 18 years of age
Key exclusion criteria (13 listed)
- Evidence of leptomeningeal metastases.
- Need immediate treatment to prevent neurological deterioration.
- Prior brain radiotherapy or surgery for current brain metastases.
- Radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.
- Absolute neutrophil count (ANC)<1500/mm3 or platelets <50,000/mms.
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: Ribomustin, Treanda40 mg/m2 will be administered IV on days 1,2,and 3 prior to surgery.on each day of SRT. | Drug | Bendamustine and Fractionated stereotactic radiotherapy |
| laboratory biomarker analysisAlso: Laboratory Proceduresamples will be obtained on day 1 or 2 only from patients undergoing surgery on day 3 (i.e. PK samples will not be collected from patients who begin SRT on day 1). | Other | Bendamustine and Fractionated stereotactic radiotherapy |
| Surgical Resection of Brain MetastasesAlso: surgerySurgical Resection of Brain Metastases Day 3 (immediately after Bendamustine) | Procedure or surgery | Bendamustine and Fractionated stereotactic radiotherapy |
| Stereotactic body radiation therapyAlso: SRT, Stereotactic Fractionated Radiation TherapyStarting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri) | Radiation | Bendamustine and Fractionated stereotactic radiotherapy |
Primary outcome
Determine recommended dose of Bendamustine when used in combination with Stereotactic Radiotherapy (STR) for treatment of patients with 1-4 brain metastases.
Time frame: up to 4 years
3 secondary outcomes
Pharmacokinetics of bendamustine
Time frame: up to 4 years
Levels of bendamustine hydrochloride in the brain metastases, brain margin, arachnoid, cerebral spinal fluid, and plasma
Time frame: up to 4 years
Local control of brain metastases
Time frame: up to 4 years
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 17 May 2018.
- JameslineLink 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.
John C. Grecula, MD principal investigator
Ohio State University
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, laboratory biomarker analysis and Surgical Resection of Brain Metastases in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by John Grecula 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 6 inclusion and 13 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 17 May 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 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 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.
What does the primary outcome measure?
Determine recommended dose of Bendamustine when used in combination with Stereotactic Radiotherapy (STR) for treatment of patients with 1-4 brain metastases. (time frame: up to 4 years). 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 17 May 2018.