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

NCT00441467 | Completed Phase 2 Results

• 1 other identifier: TH-CR-305
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 7

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. 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. 2.To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma
3. 3.To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET
4. 4.To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Progression-free Survival

  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.

• Overall Survival

  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.

Study Arms (1)

Glufosfamide

EXPERIMENTAL

Glufosfamide

Drug: Glufosfamide

Interventions

Glufosfamide DRUG

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

Glufosfamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eleison Pharmaceuticals LLC.: lead
• Threshold Pharmaceuticals: collaborator

Study Sites (7)

Premiere Oncology of Arizona

Scottsdale, Arizona, 85260, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Washington University School of Medicine, Division of Oncology

St Louis, Missouri, 63110, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

St. Vincent's Comprehensive Cancer Center

New York, New York, 10011, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

beta-D-glucosylisophosphoramide mustard

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: VP Clinical Development
• Organization: Eleison Pharmaceuticals

matthew.parris@eleison-pharma.com

6097211227

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: March 1, 2007
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 25, 2015
• Results First Posted: March 2, 2015

Record last verified: 2015-03

Locations

US (7)