search
Back to results

Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring metastatic osteosarcoma, recurrent adult soft tissue sarcoma, recurrent osteosarcoma, adult rhabdomyosarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, stage IV adult soft tissue sarcoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed sarcoma Soft tissue metastasis or locally recurrent disease Stratum I (closed to accrual as of 10/17/03): Soft tissue sarcoma not specified in stratum II Osteogenic sarcoma arising from soft tissue or gastrointestinal stromal tumor (GIST) Stratum II: Ewing's sarcoma of soft tissue or bone (if measurable soft tissue metastasis is present) Rhabdomyosarcoma Osteogenic sarcoma of bone (if measurable soft tissue metastasis is present) At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Disease progression within the past 3 months No prior or active known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% OR ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No peripheral vascular disease requiring surgical management No history of congestive heart failure even if it is medically controlled No angina pectoris even if it is medically controlled No myocardial infarction within the past year No cardiac arrhythmias No prior cerebrovascular event No prior transient ischemic attack No EKG evidence of acute ischemia or conduction abnormality (e.g., bifascicular block [left anterior hemiblock in the presence of right bundle branch block] or second or third degree atrioventricular block) No history of orthostatic hypotension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction to compounds of similar chemical or biological composition to study drug No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No symptomatic peripheral neuropathy greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent biological or immunological agents Chemotherapy: Stratum I (closed to accrual as of 10/17/03): At least 1 year since prior chemotherapy in the adjuvant or neoadjuvant setting No other prior chemotherapy Stratum II: No more than 1 prior chemotherapy regimen No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: Prior imatinib mesylate for GIST (stratum I closed to accrual as of 10/17/03) allowed No other concurrent investigational agents No concurrent commercial anticancer agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients

Sites / Locations

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Albert Einstein College of Medicine
  • Memorial Sloan-Kettering Cancer Center
  • University of Chicago Cancer Research Center
  • Abramson Cancer Center at University of Pennsylvania Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
June 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00027716
Brief Title
Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
Official Title
A Multi-Institutional, Open-Label, Two-Group, Phase II Study of PS-341 (LDP-341, NSC #681239) in Patients With Advanced or Metastatic Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have advanced or metastatic sarcoma.
Detailed Description
OBJECTIVES: Determine the response rate in patients with advanced or metastatic sarcoma treated with bortezomib. Correlate levels of cyclins D1, E, p21 (WAF1), p27 (Kip1), mdm^2, p53, and Ki67 with response in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease (stratum I: soft tissue sarcoma not specified in stratum II, osteogenic sarcoma arising from soft tissues, or gastrointestinal stromal tumor vs stratum II: Ewing's sarcoma of soft tissue or bone, rhabdomyosarcoma, or osteogenic sarcoma of bone). (Stratum I closed to accrual as of 10/17/03.) Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for stratum I within 5-11 months and 21-41 patients will be accrued for stratum II within 10.5-22 months. (Stratum I closed to accrual as of 10/17/03.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
metastatic osteosarcoma, recurrent adult soft tissue sarcoma, recurrent osteosarcoma, adult rhabdomyosarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed sarcoma Soft tissue metastasis or locally recurrent disease Stratum I (closed to accrual as of 10/17/03): Soft tissue sarcoma not specified in stratum II Osteogenic sarcoma arising from soft tissue or gastrointestinal stromal tumor (GIST) Stratum II: Ewing's sarcoma of soft tissue or bone (if measurable soft tissue metastasis is present) Rhabdomyosarcoma Osteogenic sarcoma of bone (if measurable soft tissue metastasis is present) At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Disease progression within the past 3 months No prior or active known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% OR ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No peripheral vascular disease requiring surgical management No history of congestive heart failure even if it is medically controlled No angina pectoris even if it is medically controlled No myocardial infarction within the past year No cardiac arrhythmias No prior cerebrovascular event No prior transient ischemic attack No EKG evidence of acute ischemia or conduction abnormality (e.g., bifascicular block [left anterior hemiblock in the presence of right bundle branch block] or second or third degree atrioventricular block) No history of orthostatic hypotension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction to compounds of similar chemical or biological composition to study drug No other uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No symptomatic peripheral neuropathy greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent biological or immunological agents Chemotherapy: Stratum I (closed to accrual as of 10/17/03): At least 1 year since prior chemotherapy in the adjuvant or neoadjuvant setting No other prior chemotherapy Stratum II: No more than 1 prior chemotherapy regimen No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: Prior imatinib mesylate for GIST (stratum I closed to accrual as of 10/17/03) allowed No other concurrent investigational agents No concurrent commercial anticancer agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Maki, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Abramson Cancer Center at University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma

We'll reach out to this number within 24 hrs