A Study Evaluating IV Oncaspar® and IV Gemzar® in the Treatment of Solid Tumors and Lymphoma

May 16, 2008 updated by: Enzon Pharmaceuticals, Inc.

A Multicenter, Open-Label, Phase I Study Evaluating the Safety and Tolerability of Intravenous Pegaspargase in Combination With Intravenous Gemcitabine HCl in the Treatment of Advanced and/or Metastatic Solid Tumors and Lymphoma

This study will research the side effects of pegaspargase (pronounced "peg-as-par-gase"); its brand name is ONCASPAR® when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl (pronounced "gem-site-a-bean"; its brand name is GEMZAR®.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is for the study's sponsor, Enzon Pharmaceuticals, Inc. ("Enzon"), to learn more about its drug pegaspargase. Pegaspargase is the drug's scientific or generic name. Because it is already approved by the Food and Drug Administration (FDA), it also has a brand name - ONCASPAR®. It is approved by the FDA for the treatment of a type of leukemia (cancer of white blood cells). However, pegaspargase is not approved by the FDA for treatment of the cancer in this study. This study will research the side effects of pegaspargase when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl; its brand name is GEMZAR®. It is approved for the treatment of patients with cancer of the pancreas and of patients with breast cancer. However, gemcitabine is not approved by the FDA for treatment of any other types of cancer.

In addition, the combination of pegaspargase and gemcitabine for solid tumors and lymphoma in this study is investigational. This type of study treatment is called a "combination treatment" or a "combination study." The information (research data) from this study will be used by Enzon to plan other "combination" research studies with pegaspargase plus gemcitabine for the treatment of certain cancers.

Study Type

Interventional

Enrollment (Actual)

19

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
      • Scottsdale, Arizona, United States, 85258
        • TGen Clinical Research Services at Scottsdale Healthcare
    • Nebraska
      • Omaha, Nebraska, United States, 68198-8511
        • University of Nebraska Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy & Research Center, Institute for Drug Development

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

Inclusion Criteria:

  • Capable of understanding the protocol requirements and risks and providing written informed consent.
  • Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma (Hodgkin's or non-Hodgkin's), and have either failed primary treatment or there is no available standard treatment.
  • Prior standard therapy was not effective, or no known therapy will extend survival or provide benefit.
  • Measurable or evaluable disease.
  • Age 18 years or older.
  • Score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
  • Absolute neutrophil count (ANC)≥ 1500/μL.
  • Platelet count ≥ 100,000/μL.
  • Hemoglobin ≥ 9.0 g/dL.
  • Fibrinogen ≥ 0.75x the lower limit of normal (LLN), and PT, PTT, and INR ≤ 1.5x the upper limit of normal (ULN).
  • Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.
  • Total bilirubin ≤ 1.5 mg/dL.
  • Transaminases (AST, ALT) ≤ 2.5x the upper limit of normal (ULN) (may be ≤ 5.0x ULN if due to metastatic disease in the liver).
  • Amylase and lipase levels are within normal limits.

Any subject who has given informed consent to participate in the clinical study and who meets all entry criteria for the study may participate in the tumor analysis part of the study.

Exclusion Criteria:

  • Subjects meeting any of the following exclusion criteria will not be eligible for enrollment.
  • Concurrent serious medical illness that could potentially interfere with protocol compliance.
  • Has pancreatitis or a history of pancreatitis, not related to pancreatic cancer.
  • Has a coagulopathy or a history of coagulopathy.
  • Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).
  • Positive screening pregnancy test or is breast-feeding.
  • Female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
  • Known or clinically suspected active brain metastases.
  • Received pegaspargase (Oncaspar®, PEG-L-asparaginase) or any asparaginase or asparaginase-containing drug, at any time prior to this study.
  • Received prior chemotherapy, immunotherapy or an investigational agent regimen

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
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objectives of this Phase 1 study of pegaspargase in combination with gemcitabine are to determine the maximum tolerated dose of IV pegaspargase when administered with gemcitabine
and to determine the recommended Phase 2 dose of pegaspargase

Secondary Outcome Measures

Outcome Measure
The secondary objectives of this study are to evaluate the safety and tolerability of the combination study treatment
to determine the PD/PK profile and immunogenicity of pegaspargase
to determine the PK profile of gemcitabine when administered in combination with pegaspargase
and to detect preliminary evidence of tumor

Collaborators and Investigators

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

Sponsor

Enzon Pharmaceuticals, Inc.

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

July 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

August 9, 2006

First Submitted That Met QC Criteria

August 10, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Estimate)

May 20, 2008

Last Update Submitted That Met QC Criteria

May 16, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EZ-002-001

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.

Subscribe