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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282022
• Other study ID #: CDR0000456623
• Secondary ID: VION-CLI-039
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: November 5, 2013
• Start date: September 2005

Study information

• Verified date: January 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• laromustine

Locations

Country	Name	City	State
United States	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Sarah Cannon Cancer Center at Centennial Medical Center	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut
United States	Helen F. Graham Cancer Center at Christiana Hospital	Newark	Delaware
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Veterans Affairs Medical Center - West Haven	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Vion Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (complete and partial response)			No
Primary	Toxicity			Yes