VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas

July 17, 2013 updated by: Vion Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

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
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8028
        • Yale Comprehensive Cancer Center
      • West Haven, Connecticut, United States, 06516
        • Veterans Affairs Medical Center - West Haven

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 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

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 active uncontrolled bleeding

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • 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

Pulmonary:

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

Other:

  • 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)

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

  • At least 3 weeks since prior radiotherapy and recovered

Surgery:

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

Other:

  • No other concurrent standard therapy for cancer
  • No other concurrent investigational agents
  • No concurrent disulfiram (Antabuse)

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

March 1, 2001

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

October 11, 2001

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-011
  • CDR0000068919 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-V01-1669

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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