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

This study has been completed.
Sponsor:
Collaborator:
Threshold Pharmaceuticals
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.
ClinicalTrials.gov Identifier:
NCT00441467
First received: February 27, 2007
Last updated: March 3, 2015
Last verified: March 2015
  Purpose

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

Condition Intervention Phase
Soft Tissue Sarcoma
Drug: Glufosfamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Study of the Efficacy and Safety of Glufosfamide in Previously Treated Advanced Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by Eleison Pharmaceuticals LLC.:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Tumor assessments were performed at baseline and every 6 weeks until disease progression was documented. ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
  • Overall 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. ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glufosfamide
Glufosfamide
Drug: Glufosfamide
5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441467

Locations
United States, Arizona
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Missouri
Washington University School of Medicine, Division of Oncology
St. Louis, Missouri, United States, 63110
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
Sponsors and Collaborators
Eleison Pharmaceuticals LLC.
Threshold Pharmaceuticals
Investigators
Principal Investigator: Lee Cranmer, MD, PhD University of Arizona
Principal Investigator: David Mendelson, MD Premiere Oncology of Arizona
Principal Investigator: Douglas Adkins, MD Washington University School of Medicine, Division of Oncology
Principal Investigator: Gina D'Amato, MD H. Lee Moffitt Cancer Center
Principal Investigator: Gerald Rosen, MD St. Vincent's Comprehensive Cancer Center
Principal Investigator: Claire Verschraegen, MD University of New Mexico Cancer Center
Principal Investigator: Kristen Ganjoo, MD Stanford University
  More Information

No publications provided

Responsible Party: Eleison Pharmaceuticals LLC.
ClinicalTrials.gov Identifier: NCT00441467     History of Changes
Other Study ID Numbers: TH-CR-305
Study First Received: February 27, 2007
Results First Received: February 16, 2015
Last Updated: March 3, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Ifosfamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015