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

NCT ID: NCT00441467

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-10-31

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:

1. 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

2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma

Exploratory Objectives:

1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET

2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Conditions

Soft Tissue Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glufosfamide

Glufosfamide

Group Type: EXPERIMENTAL

Glufosfamide

Intervention Type: DRUG

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

Interventions

Glufosfamide

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Threshold Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Eleison Pharmaceuticals LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Cranmer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

David Mendelson, MD

Role: PRINCIPAL_INVESTIGATOR

Premiere Oncology of Arizona

Douglas Adkins, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine, Division of Oncology

Gina D'Amato, MD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center

Gerald Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

St. Vincent's Comprehensive Cancer Center

Claire Verschraegen, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Cancer Center

Kristen Ganjoo, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Premiere Oncology of Arizona

Scottsdale, Arizona, United States

Arizona Cancer Center

Tucson, Arizona, United States

Stanford Cancer Center

Stanford, California, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Washington University School of Medicine, Division of Oncology

St Louis, Missouri, United States

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, United States

St. Vincent's Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

TH-CR-305

Identifier Type: -

Identifier Source: org_study_id