Safety and Efficacy Study of Glufosfamide in Patients With Recurrent Sensitive Small Cell Lung Carcinoma

NCT00435578 | Terminated Phase 2

• 1 other identifier: TH-CR-304
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objectives of this study are:

1. 1.To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive small cell lung cancer (SCLC) as measured by objective response rate
2. 2.To evaluate the safety of glufosfamide in subjects with extensive recurrent sensitive SCLC
3. 3.To evaluate the efficacy of glufosfamide in subjects with extensive recurrent sensitive SCLC as measured by duration of response, progression-free survival and overall survival
4. 4.To evaluate the pharmacokinetics of glufosfamide and isophosphoramide mustard (IPM)
5. 5.To evaluate the effect of glufosfamide on lung cancer symptoms
6. 6.To evaluate the role of tumor cell glucose transporter expression on the efficacy of glufosfamide

Conditions

Carcinoma, Small Cell Lung

Keywords

Recurrent Sensitive Small-Cell Lung Cancer

Interventions

Glufosfamide DRUG

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/IEC
• Documented extensive SCLC with progression occurring at least 60 days after completion of first-line therapy (sensitive disease)
• Measurable disease by RECIST criteria (at least one target lesion; no target lesion may have received radiotherapy within 6 weeks of study start)
• A minimum of 21 days between prior radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
• Recovered from reversible toxicities of prior therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
• Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1,500/µL, platelets ≥ 100,000/µL
• Total bilirubin ≤ 1.5-fold ULN
• AST/ALT ≤ 2.5-fold ULN (≤ 5-fold ULN if liver metastases)
• Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula)
• All women of childbearing potential and all men 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:

• More than one previous chemotherapy regimen
• Concomitant or planned hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for SCLC other than protocol therapy
• Limited stage SCLC (defined as confined to one hemithorax including ipsilateral supraclavicular lymph nodes and excluding pleural effusion)
• Symptomatic brain metastases requiring corticosteroids
• Active clinically significant infection requiring antibiotics
• Known HIV positive or active hepatitis B or C
• 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, congestive heart failure, or stroke
• Other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past 5 years
• Major surgery within 28 days 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 28 days of the first day of dosing on this study
• Concomitant disease or condition that could interfere with the conduct of the study, or that, in the opinion of the investigator, could 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

• Threshold Pharmaceuticals: lead

Study Sites (3)

California Cancer Center

Greenbrae, California, 94904, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

beta-D-glucosylisophosphoramide mustard

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gerold Bepler, MD, PhD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

• John C Ruckdeschel, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

• Peter D Eisenberg, MD

  California Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 15, 2007
• Study Start: February 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 30, 2009

Record last verified: 2009-04

Locations

US (3)