VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025129
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
Information provided by:
National Cancer Institute (NCI)

October 11, 2001
January 27, 2003
July 18, 2013
March 2001
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Complete list of historical versions of study NCT00025129 on Archive Site
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VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced solid tumors or lymphomas.


  • Determine the maximum tolerated dose of VNP40101M in patients with advanced solid tumors or lymphomas.
  • Determine the toxic effects of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the anti-tumor effects of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive VNP40101M IV over 15 minutes on day 1. Treatment repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.

Phase 1
Primary Purpose: Treatment
  • Lymphoma
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: laromustine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2004
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  • Histologically confirmed advanced and/or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists
  • Measurable or evaluable metastatic disease
  • No other hematologic malignancy
  • No large pleural, pericardial, or peritoneal effusions
  • No requirement for immediate palliative treatment, including surgery
  • No symptomatic brain metastases or metastases with substantial edema

    • Asymptomatic brain metastases or primary CNS disease allowed if neurologic deficits are stable



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 3 months


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hematocrit at least 30% (transfusion allowed)
  • No active uncontrolled bleeding


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver or bone metastases present)
  • PT and aPTT no greater than 1.5 times ULN
  • Albumin at least 2.5 g/dL


  • Creatinine no greater than 2.0 mg/dL


  • Ejection fraction at least 45%
  • No active heart disease
  • No myocardial infarction within the past 3 months
  • No symptomatic coronary artery disease
  • No arrhythmias requiring medication
  • No uncontrolled congestive heart failure


  • DLCO and FEV_1 at least 60% of predicted
  • No dyspnea with minimal to moderate exertion


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No active infection
  • Persistent stable chronic toxic effects from prior therapy allowed if no greater than grade 1
  • No bleeding diathesis (e.g., active peptic ulcer disease)


Biologic therapy:

  • At least 3 weeks since prior biologic agents and recovered
  • At least 6 months since prior high-dose chemotherapy regimen with stem cell support


  • See Biologic therapy
  • At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • At least 2 weeks since prior hormonal therapy and recovered


  • At least 3 weeks since prior radiotherapy and recovered


  • See Disease Characteristics
  • At least 2 weeks since prior surgery and recovered


  • No other concurrent standard therapy for cancer
  • No other concurrent investigational agents
  • No concurrent disulfiram (Antabuse)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000068919 ( Registry Identifier: PDQ (Physician Data Query) )
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Vion Pharmaceuticals
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Study Chair: Mario Sznol, MD Vion Pharmaceuticals
National Cancer Institute (NCI)
March 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP