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Status:

COMPLETED

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

Lead Sponsor:

Vion Pharmaceuticals

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 ...

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. * Determ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    87 Patients enrolled

    Trial Details

    Trial ID

    NCT00282022

    Start Date

    September 1 2005

    Last Update

    November 6 2013

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    2

    Yale Cancer Center

    New Haven, Connecticut, United States, 06520-8028

    3

    Veterans Affairs Medical Center - West Haven

    West Haven, Connecticut, United States, 06516

    4

    Helen F. Graham Cancer Center at Christiana Hospital

    Newark, Delaware, United States, 19713