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Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

Primary Purpose

Soft Tissue Sarcoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Glufosfamide

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma

Eligibility Criteria

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

Inclusion Criteria:

At least 18 years of age
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
Pathologically confirmed diagnosis of soft tissue sarcoma
Locally advanced unresectable or metastatic disease with no standard curative therapy available that has progressed since the most recent therapy
Measurable disease by RECIST criteria with at least one target lesion
1 or 2 prior chemotherapy/systemic therapy regimens for advanced disease
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
A minimum of 3 weeks between prior chemotherapy, radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
Recovered from reversible toxicities of prior therapy
Hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1,500/µL, platelets ≥ 100,000/µL
Total bilirubin ≤ 1.5-fold ULN, AST/ALT ≤ 2.5-fold ULN (≤ 5-fold if liver metastases)
Normal creatinine clearance (≥85 mL/min for men and ≥75 mL/min for women; calculated by Cockcroft-Gault formula
All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose

Exclusion Criteria:

Soft tissue sarcoma of the following subtypes: gastrointestinal stromal tumor (GIST), alveolar soft parts sarcoma, hemangiopericytoma and Kaposi's sarcoma
Most recent relapse occurring during treatment with ifosfamide within 4 weeks of last dose
Symptomatic brain or leptomeningeal metastases
Active clinically significant infection requiring antibiotics
Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, cerebrovascular accident or congestive heart failure
Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
Major surgery within 3 weeks of the start of study treatment, without complete recovery
Females who are pregnant or breast-feeding
Participation in an investigational drug or device study within 21 days of study entry
Concomitant disease or condition that could interfere with the conduct of the study, or that in the opinion of the investigator would pose an unacceptable risk to the subject in this study
Unwillingness or inability to comply with the study protocol for any other reason

Sites / Locations

Premiere Oncology of Arizona
Arizona Cancer Center
Stanford Cancer Center
H. Lee Moffitt Cancer Center
Washington University School of Medicine, Division of Oncology
University of New Mexico Cancer Research and Treatment Center
St. Vincent's Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glufosfamide

Arm Description

Glufosfamide

Outcomes

Primary Outcome Measures

Objective Response Rate

The event rate was the response rate (complete and partial response) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). The associated 95% exact binomial confidence intervals were calculated.

Secondary Outcome Measures

Progression-free Survival

Overall Survival

Full Information

NCT ID

NCT00441467

First Posted

February 27, 2007

Last Updated

March 3, 2015

Sponsor

Eleison Pharmaceuticals LLC.

Collaborators

Threshold Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00441467

Brief Title

Safety and Efficacy Study of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

Official Title

An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eleison Pharmaceuticals LLC.

Collaborators

Threshold Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

Primary Objective: 1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate Secondary Objectives: To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma Exploratory Objectives: To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

6. Conditions and Keywords

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

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

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glufosfamide

Arm Type

Experimental

Arm Description

Glufosfamide

Intervention Type

Drug

Intervention Name(s)

Glufosfamide

Intervention Description

5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

Time Frame

Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented.

Secondary Outcome Measure Information:

Title

Progression-free Survival

Time Frame

All subjects were followed regularly until glufosfamide discontinuation, tumor progression or additional antitumor therapy was started and then were followed for survival at 3 month intervals for the first year and once every year thereafter until death.

Title

Overall Survival

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 18 years of age Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee Pathologically confirmed diagnosis of soft tissue sarcoma Locally advanced unresectable or metastatic disease with no standard curative therapy available that has progressed since the most recent therapy Measurable disease by RECIST criteria with at least one target lesion 1 or 2 prior chemotherapy/systemic therapy regimens for advanced disease Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2 A minimum of 3 weeks between prior chemotherapy, radiation therapy, immunotherapy, or other anti-tumor therapy and study entry Recovered from reversible toxicities of prior therapy Hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1,500/µL, platelets ≥ 100,000/µL Total bilirubin ≤ 1.5-fold ULN, AST/ALT ≤ 2.5-fold ULN (≤ 5-fold if liver metastases) Normal creatinine clearance (≥85 mL/min for men and ≥75 mL/min for women; calculated by Cockcroft-Gault formula All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose Exclusion Criteria: Soft tissue sarcoma of the following subtypes: gastrointestinal stromal tumor (GIST), alveolar soft parts sarcoma, hemangiopericytoma and Kaposi's sarcoma Most recent relapse occurring during treatment with ifosfamide within 4 weeks of last dose Symptomatic brain or leptomeningeal metastases Active clinically significant infection requiring antibiotics Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, cerebrovascular accident or congestive heart failure Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years Major surgery within 3 weeks of the start of study treatment, without complete recovery Females who are pregnant or breast-feeding Participation in an investigational drug or device study within 21 days of study entry Concomitant disease or condition that could interfere with the conduct of the study, or that in the opinion of the investigator would pose an unacceptable risk to the subject in this study Unwillingness or inability to comply with the study protocol for any other reason

Overall Study Officials: