VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer

November 5, 2013 updated by: Vion Pharmaceuticals

A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well VNP40101M works in treating patients with recurrent or refractory locally advanced or metastatic small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the overall response rate (partial and complete) in patients with relapsed or refractory locally advanced or metastatic small cell lung cancer treated with VNP40101M.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease state (sensitive relapse [progressive disease > 3 months after responding to first-line chemotherapy] vs resistant disease [progressive disease during or ≤ 3 months after first-line chemotherapy]).

Patients receive VNP40101M IV over 15-30 minutes once weekly for 3 weeks. Treatment repeats every 6 weeks for up to 6 courses. Patients achieving a complete response (CR) receive 2 additional courses of therapy after CR.

After completion of study treatment, patients are followed periodically for up to 18 months.

PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8028
        • Yale Cancer Center
      • West Haven, Connecticut, United States, 06516
        • Veterans Affairs Medical Center - West Haven
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F. Graham Cancer Center at Christiana Hospital
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center at Centennial Medical Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Cytologically confirmed small cell lung cancer

    • Locally advanced or metastatic disease
    • Recurrent or progressive disease after first-line standard cytotoxic therapy
  • Measurable or evaluable disease
  • Brain metastasis allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 2 months
  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 2.5 mg/dL
  • AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active uncontrolled bleeding
  • No active infection
  • Must not require supplemental oxygen at rest
  • No active heart disease
  • No myocardial infarction within the past 3 months
  • No uncontrolled congestive heart failure
  • No uncontrolled arrhythmias
  • No uncontrolled coronary artery disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 3 weeks since prior radiotherapy, biologic therapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)

    • Prior radiotherapy within the past 3 weeks allowed if exposure involves no more than 30% of bones with significant bone marrow-producing capabilities (e.g., vertebral bodies and long bones)
  • At least 2 weeks since prior surgery or hormonal therapy
  • Must not require any immediate palliative treatment including surgery
  • Must have recovered from prior anticancer therapy

    • Persistent, stable chronic toxic effects ≤ grade 1 are allowed
  • No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease
  • No other concurrent anticancer therapy
  • No other concurrent investigational agent
  • No concurrent disulfiram

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Overall response rate (complete and partial response)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Bonny L. Johnson, RN, MSN, Vion Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 24, 2006

First Submitted That Met QC Criteria

January 24, 2006

First Posted (Estimate)

January 25, 2006

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

January 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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