Eribulin and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery

NCT03361436 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY00017190NCI-2017-02120
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This phase Ib trials studies the side effects and best dose of eribulin mesylate when given together with radiation therapy in treating patients with retroperitoneal liposarcoma that can be removed by surgery. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells.

Conditions

Malignant Solid Neoplasm; Malignant Spermatic Cord Neoplasm; Liposarcoma; Malignant Abdominal Neoplasm; Malignant Retroperitoneal Neoplasm; Malignant Scrotal Neoplasm

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03

  All adverse events will be tabulated and summarized by major organ category, grade, anticipation, and drug attribution. Serious adverse events (SAE) specific incidence and exact 95% confidence interval will be provided where appropriate.

  Up to 42 days

Secondary Outcomes (10)

• Rate of enrollment

  Up to 18 months

• Rate of early surgical resection

  3 weeks after radiation therapy

• Rate of surgical resection

  After 10 weeks of radiation, until study completion (up to 4 years)

• Change in subject-reported quality of life assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)

  Baseline up to 9 weeks after surgery

• Rate of R0 resection defined as the proportion of surgical specimens with microscopically negative margins

  Up to 10 years

Study Arms (1)

Treatment (eribulin mesylate, IMRT, surgery)

EXPERIMENTAL

Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8 and undergo intensity-modulated radiation therapy QD 5 days a week beginning on day 8 of cycle 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery within 3-10 weeks after radiation therapy.

Drug: Eribulin Mesylate; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Therapeutic Conventional Surgery

Interventions

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery

Treatment (eribulin mesylate, IMRT, surgery)

Eribulin Mesylate DRUG

Given IV

Also known as: B1939 Mesylate, E7389, ER-086526, Halaven, Halichondrin B Analog

Treatment (eribulin mesylate, IMRT, surgery)

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

Treatment (eribulin mesylate, IMRT, surgery)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (eribulin mesylate, IMRT, surgery)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (eribulin mesylate, IMRT, surgery)

Questionnaire Administration OTHER

Ancillary studies

Treatment (eribulin mesylate, IMRT, surgery)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed diagnosis of liposarcoma; all subtypes are eligible
• Sufficient archival tissue available for correlative studies; submission of formalin-fixed paraffin-embedded (FFPE) tumor tissue from a previous biopsy or resection is required, and the most recent specimen is preferred; if a FFPE block cannot be provided, then 10 unstained, positively-charged slides of 4-5 um thickness must be submitted; if insufficient archival tissue is available, a repeat biopsy will be necessary
• Primary or recurrent retroperitoneal, scrotal/spermatic cord or abdominal tumor
• For subjects between the ages of 12-18 years only, body surface area (BSA) must be \>= 1.5 m\^2
• All sites of disease must be resectable or borderline resectable as assessed by a surgical oncologist with experience in retroperitoneal sarcoma resection after discussion in our institutional multidisciplinary sarcoma tumor board conference
• All sites of disease must be targetable with intensity-modulated radiation therapy (IMRT) with acceptable morbidity and without exceeding normal tissue dose constraints as assessed by a radiation oncologist
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening
• Fridericia's correction formula (QTcF) interval on standard 12-lead electrocardiography (ECG) parameters at screening (defined as the mean of the triplicate ECGs) of \< 450 msec for males and \< 470 msec for females
• Ejection fraction of \>= 50%
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
• Individuals of childbearing potential must be willing to use adequate contraception throughout the study and for 3 weeks after study drug discontinuation
• Absolute neutrophil count (ANC) \>= 1 K/cu mm
• Platelets (no transfusion within prior 7 days) \>= 100 K/cu mm
• Hemoglobin (no transfusion within prior 7 days) \>= 9.0 g/dL

You may not qualify if:

• Prior radiation or systemic therapy for the diagnosis of liposarcoma
• Prior eribulin
• Grade \>= 2 peripheral neuropathy
• Contraindication to magnetic resonance imaging (MRI), including presence of a pacemaker or aneurysm clip, severe claustrophobia, a known reaction to gadolinium contrast, or body weight exceeding 300 pounds (lbs)
• Concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of malignancies that have completed therapy and are considered by their physician to be at less than 30% risk of relapse; prior systemic therapy is allowed with the exception of prior eribulin; prior radiation therapy is allowed with the exception of any abdominal, pelvic or retroperitoneal radiation \> 10 Gy
• History of uncontrolled arrhythmia, congenital long QT syndrome or torsades de pointes (TdP)
• Use of more than one medication with a known risk of TdP
• Major operation within 14 days prior to starting study drug or not recovered from surgical complications; neither tumor biopsy nor central line insertion are considered a major operation
• Active infection; any systemic antimicrobial therapy must be completed \>= 5 days prior to initiation of protocol therapy
• Pregnant or nursing (lactating) individuals; NOTE: Pregnant individuals are excluded from this study because eribulin is an investigational agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the individual with eribulin breastfeeding should be discontinued; these potential risks may also apply to doxorubicin
• Unable or unwilling to stop the use of herbal supplements; the use of marijuana or its derivatives is allowed; the use of supplements may be allowed after review by a study pharmacist to confirm no significant risk of interaction with eribulin or radiation

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Eisai Inc.: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.

  PMID: 32827353 DERIVED

MeSH Terms

Conditions

Liposarcoma

Interventions

eribulin; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Lara E Davis

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: March 19, 2018
• Primary Completion: February 14, 2023
• Study Completion (Estimated): April 14, 2033
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)