VNP40101M in Treating Patients With Advanced or Metastatic Cancer

July 17, 2013 updated by: Vion Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8028
        • Yale Comprehensive Cancer Center
      • West Haven, Connecticut, United States, 06516
        • Veterans Affairs Medical Center - West Haven
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vion Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 17, 2013

Last Verified

March 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VION-CLI-028
  • CDR0000258355 (Registry Identifier: PDQ (Physician Data Query))
  • YALE-HIC-16775

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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