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

NCT00282022 | Completed Phase 2

• 2 other identifiers: CDR0000456623VION-CLI-039
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 9

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.

Conditions

Lung Cancer

Keywords

recurrent small cell lung cancer; extensive stage small cell lung cancer; limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Overall response rate (complete and partial response)

• Toxicity

Interventions

laromustine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vion Pharmaceuticals: lead

Study Sites (9)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Veterans Affairs Medical Center - West Haven

West Haven, Connecticut, 06516, United States

Location

Helen F. Graham Cancer Center at Christiana Hospital

Newark, Delaware, 19713, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Interventions

laromustine

Condition Hierarchy (Ancestors)

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

Study Officials

• Bonny L. Johnson, RN, MSN

  Vion Pharmaceuticals

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: September 1, 2005
• Primary Completion: May 1, 2008
• Last Updated: November 6, 2013

Record last verified: 2009-01

Locations

US (9)