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VNP40101M in Treating Patients With Advanced or Metastatic Cancer
This study has been completed.
Study NCT00049699   Information provided by National Cancer Institute (NCI)
First Received: November 12, 2002   Last Updated: December 13, 2008   History of Changes

November 12, 2002
December 13, 2008
October 2002
 
 
 
Complete list of historical versions of study NCT00049699 on ClinicalTrials.gov Archive Site
 
 
 
VNP40101M in Treating Patients With Advanced or Metastatic Cancer
A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly 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 or metastatic cancer.

OBJECTIVES:

  • Determine the toxic effects of VNP40101M in patients with advanced or metastatic solid tumor or lymphoma.
  • Determine the maximum tolerated dose of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the antitumor effects of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive VNP40101M IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 28 days.

Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose is determined.

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

Phase I
Interventional
Treatment
  • Lymphoma
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: laromustine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists
  • Measurable or evaluable disease
  • Primary brain tumors or brain metastases allowed provided neurologic deficits are stable and do not preclude study compliance

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 3 months

Hematopoietic

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

Hepatic

  • PT and PTT no greater than 1.5 times the upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN
  • ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
  • Albumin at least 2.5 gm/dL

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • At least 3 months since prior myocardial infarction
  • No symptomatic coronary artery disease
  • No arrhythmias requiring medication
  • No uncontrolled congestive heart failure

Pulmonary

  • No dyspnea on minimal or moderate exertion
  • DLCO and FEV1 at least 60% predicted

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled active bleeding (e.g., active peptic ulcer disease)
  • No active infection
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Recovered from acute toxicities of prior biologic therapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)

Chemotherapy

  • More than 6 months since prior high-dose chemotherapy with stem cell support
  • More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • Recovered from acute toxicities of prior chemotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)

Endocrine therapy

  • At least 2 weeks since prior hormonal therapy

Radiotherapy

  • Recovered from acute toxicities of prior radiotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)

Surgery

  • At least 2 weeks since prior surgery

Other

  • No other concurrent standard or investigational treatment for cancer
  • No concurrent disulfiram
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00049699
 
CDR0000258355, VION-CLI-028, YALE-HIC-16775
Vion Pharmaceuticals
 
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