Clinical trial NCT00282022: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: recurrent small cell lung cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-01-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall response rate (complete and partial response)
measure: Toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: West Haven
country: United States
facility: Veterans Affairs Medical Center - West Haven
state: Connecticut
city: Newark
country: United States
facility: Helen F. Graham Cancer Center at Christiana Hospital
state: Delaware
city: Bronx
country: United States
facility: Albert Einstein Cancer Center at Albert Einstein College of Medicine
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center at Centennial Medical Center
state: Tennessee
city: Houston
country: United States
facility: M. D. Anderson Cancer Center at University of Texas
state: Texas
Study officials:
affiliation: Vion Pharmaceuticals
name: Bonny L. Johnson, RN, MSN
References: