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Sorafenib and Ifosfamide in Treating Patients With High-Grade Soft Tissue Sarcoma or Bone Sarcoma That Can Be Removed by Surgery

Primary Purpose

Sarcoma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

sorafenib

Ifosfamide

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring localized osteosarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed high grade sarcoma of the soft tissue or bone
participants Identified as a proper candidate for ifosfamide-based neoadjuvant therapy
candidates must have operable disease for which a resection is planned
ECOG performance status 0-1
Hemoglobin ≥ 9.0 g/dL
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
INR < 1.5 or PT/PTT normal.Concurrent anticoagulation therapy with warfarin or heparin allowed
Creatinine ≤ 1.5 times ULN
women of childbearing potential must have negative pregnancy test performed within 7 days prior to start of treatment.
Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy.
A signed informed consent must be obtained prior to any study specific procedures.

Exclusion Criteria:

known HIV infection
chronic hepatitis B or C infection
clinically active serious infection > CTCAE grade 2
NYHA class III or IV congestive heart failure
unstable angina (i.e., anginal symptoms at rest) or new onset angina within the past 3 months
myocardial infarction within the past 6 months
cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) despite optimal medical management
thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks
other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
Any condition that would impair the ability to swallow whole pills
malabsorption problem
Any known severe hypersensitivity to sorafenib tosylate or any of its excipients
known or suspected allergy to sorafenib tosylate or any agent given in this study
serious nonhealing wound, ulcer, or bone fracture
evidence or history of bleeding diathesis or coagulopathy
significant traumatic injury within the past 4 weeks
major surgery or open biopsy within 4 weeks of starting treatment
Concomitant St. John's wort or rifampin
KNown brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastases.
any condition that impairs patients' ability to swallow pills
any malabsorption problem

Sites / Locations

Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sorafenib + Ifosfamide

Arm Description

* Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14 in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every 14-28 days* for 3 courses. NOTE: *Course 1 is 14 days in duration; courses 2 and 3 are 28 days in duration. Surgery: At least 1 week after the completion of neoadjuvant therapy, patients undergo surgery. Adjuvant therapy: Beginning ≥ 3 weeks after surgery, patients who respond to neoadjuvant therapy receive oral sorafenib twice daily for 6 months. Patients also receive 2 courses of ifosfamide as in courses 2 and 3 of neoadjuvant therapy.

Outcomes

Primary Outcome Measures

Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.

After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.

Secondary Outcome Measures

Local and Distant Recurrence-free Survival

Full Information

NCT ID

NCT00880542

First Posted

April 10, 2009

Last Updated

July 29, 2020

Sponsor

Jonsson Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00880542

Brief Title

Sorafenib and Ifosfamide in Treating Patients With High-Grade Soft Tissue Sarcoma or Bone Sarcoma That Can Be Removed by Surgery

Official Title

A Phase II Study of Sorafenib and Ifosfamide as a Treatment for Patients With Sarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

The study lost funding.

Study Start Date

August 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with ifosfamide may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with ifosfamide and to see how well it works in treating patients with high-grade soft tissue sarcoma or bone sarcoma that can be removed by surgery.

Detailed Description

OBJECTIVES: Primary Assess the safety, toxicity, and efficacy of neoadjuvant sorafenib tosylate and ifosfamide in patients with resectable high-grade soft tissue or bone sarcoma. Secondary Assess the long-term efficacy or impact of therapy in these patients, in terms of the duration of local recurrence-free survival, distant recurrence-free survival, and disease-specific survival. OUTLINE: Neoadjuvant therapy: Patients receive oral sorafenib tosylate twice daily on days 1-14 in course 1. Patients then receive oral sorafenib tosylate twice daily on days 1-28 and ifosfamide IV continuously on days 1-7 in courses 2 and 3. Treatment repeats every 14-28 days* for 3 courses. NOTE: *Course 1 is 14 days in duration; courses 2 and 3 are 28 days in duration. Surgery: At least 1 week after the completion of neoadjuvant therapy, patients undergo surgery. Adjuvant therapy: Beginning ≥ 3 weeks after surgery, patients who respond to neoadjuvant therapy receive oral sorafenib twice daily for 6 months. Patients also receive 2 courses of ifosfamide as in courses 2 and 3 of neoadjuvant therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

Keywords

localized osteosarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sorafenib + Ifosfamide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

sorafenib

Intervention Description

Patients with sarcoma who have resectable disease will be treated with neoadjuvant sorafenib and ifosfamide. PET/CT will be used to assess the metabolic and radiographic response to therapy.

Intervention Type

Drug

Intervention Name(s)

Ifosfamide

Intervention Description

Patients with sarcoma who have resectable disease will be treated with neoadjuvant ifosfamide and sorafenib. PET/CT will be used to assess the metabolic and radiographic response to therapy.

Primary Outcome Measure Information:

Title

Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.

Description

Time Frame

Participants were followed for duration of study, an average of 1 year.

Secondary Outcome Measure Information:

Title

Local and Distant Recurrence-free Survival

Time Frame

conclusion of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed high grade sarcoma of the soft tissue or bone participants Identified as a proper candidate for ifosfamide-based neoadjuvant therapy candidates must have operable disease for which a resection is planned ECOG performance status 0-1 Hemoglobin ≥ 9.0 g/dL ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement) INR < 1.5 or PT/PTT normal.Concurrent anticoagulation therapy with warfarin or heparin allowed Creatinine ≤ 1.5 times ULN women of childbearing potential must have negative pregnancy test performed within 7 days prior to start of treatment. Fertile patients must use effective contraception during and for ≥ 2 weeks after completion of study therapy. A signed informed consent must be obtained prior to any study specific procedures. Exclusion Criteria: known HIV infection chronic hepatitis B or C infection clinically active serious infection > CTCAE grade 2 NYHA class III or IV congestive heart failure unstable angina (i.e., anginal symptoms at rest) or new onset angina within the past 3 months myocardial infarction within the past 6 months cardiac ventricular arrhythmias requiring anti-arrhythmic therapy uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) despite optimal medical management thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks Any condition that would impair the ability to swallow whole pills malabsorption problem Any known severe hypersensitivity to sorafenib tosylate or any of its excipients known or suspected allergy to sorafenib tosylate or any agent given in this study serious nonhealing wound, ulcer, or bone fracture evidence or history of bleeding diathesis or coagulopathy significant traumatic injury within the past 4 weeks major surgery or open biopsy within 4 weeks of starting treatment Concomitant St. John's wort or rifampin KNown brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastases. any condition that impairs patients' ability to swallow pills any malabsorption problem

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Tap, MD

Organizational Affiliation

Jonsson Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jonsson Comprehensive Cancer Center at UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1781

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Sorafenib and Ifosfamide in Treating Patients With High-Grade Soft Tissue Sarcoma or Bone Sarcoma That Can Be Removed by Surgery

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