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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
laromustine
Sponsored by
Vion Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • Yale Cancer Center
  • Veterans Affairs Medical Center - West Haven
  • Helen F. Graham Cancer Center at Christiana Hospital
  • Albert Einstein Cancer Center at Albert Einstein College of Medicine
  • Cleveland Clinic Taussig Cancer Center
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Sarah Cannon Cancer Center at Centennial Medical Center
  • M. D. Anderson Cancer Center at University of Texas

Outcomes

Primary Outcome Measures

Overall response rate (complete and partial response)
Toxicity

Secondary Outcome Measures

Full Information

First Posted
January 24, 2006
Last Updated
November 5, 2013
Sponsor
Vion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00282022
Brief Title
VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer
Official Title
A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Vion Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
laromustine
Primary Outcome Measure Information:
Title
Overall response rate (complete and partial response)
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonny L. Johnson, RN, MSN
Organizational Affiliation
Vion Pharmaceuticals
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Veterans Affairs Medical Center - West Haven
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Helen F. Graham Cancer Center at Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Sarah Cannon Cancer Center at Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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