A Phase 1 interventional study of bendamustine and laboratory biomarker analysis in Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by John Grecula. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.
Sponsored by John Grecula · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 18 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →This is the only study on the registry with John Grecula as lead sponsor.
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Exclusion Criteria:
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).
Drug: bendamustine · Other: laboratory biomarker analysis · Procedure: Surgical Resection of Brain Metastases · Radiation: Stereotactic body radiation therapy
40 mg/m2 will be administered IV on days 1,2,and 3 prior to surgery.on each day of SRT.
Also known as: Ribomustin, Treanda
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).
Also known as: Laboratory Procedure
Surgical Resection of Brain Metastases Day 3 (immediately after Bendamustine)
Also known as: surgery
Starting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri)
Also known as: SRT, Stereotactic Fractionated Radiation Therapy
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
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
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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