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Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy of Patients With 1- 4 Brain Metastases From Solid Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy of Patients With 1- 4 Brain Metastases From Solid Malignancies


OBJECTIVES:

Primary

- Determine the recommended phase II dose of bendamustine hydrochloride when administered
in combination with stereotactic radiotherapy for the treatment of patients with 1-3
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.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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.

- 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine recommended dose of Bendamustine when used in combination with Stereotactic Radiotherapy (STR) for treatment of patients with 1-4 brain metastases.

Outcome Time Frame:

2009-present

Safety Issue:

Yes

Principal Investigator

John C. Grecula, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

OSU-08142

NCT ID:

NCT00837928

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Ohio State University Medical CenterColumbus, Ohio  43210