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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00282022
First received: January 24, 2006
Last updated: November 5, 2013
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: laromustine
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate (complete and partial response) [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 87
Study Start Date: September 2005
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00282022

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00282022     History of Changes
Other Study ID Numbers: CDR0000456623, VION-CLI-039
Study First Received: January 24, 2006
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent small cell lung cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014