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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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


- Determine the overall response rate (partial and complete) in patients with relapsed or
refractory locally advanced or metastatic small cell lung cancer treated with

- 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.

Inclusion Criteria


- 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


- 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

- 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


- 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

- No other concurrent anticancer therapy

- No other concurrent investigational agent

- No concurrent disulfiram

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete and partial response)

Safety Issue:


Principal Investigator

Bonny L. Johnson, RN, MSN

Investigator Affiliation:

Vion Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent small cell lung cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Yale Cancer Center New Haven, Connecticut  06520-8028
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Sarah Cannon Cancer Center at Centennial Medical Center Nashville, Tennessee  37203
Veterans Affairs Medical Center - West Haven West Haven, Connecticut  06516
Helen F. Graham Cancer Center at Christiana Hospital Newark, Delaware  19718