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

Primary Purpose

Tumors, Lymphoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma
Sponsored by
Enzon Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumors focused on measuring Advanced and/or Metastatic Solid Tumors and Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TGen Clinical Research Services at Scottsdale Healthcare
  • University of Nebraska Medical Center
  • Cancer Therapy & Research Center, Institute for Drug Development

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
August 9, 2006
Last Updated
May 16, 2008
Sponsor
Enzon Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00363610
Brief Title
A Study Evaluating IV Oncaspar® and IV Gemzar® in the Treatment of Solid Tumors and Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
No recommended Phase II dose was determined.
Study Start Date
July 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Enzon Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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®.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors, Lymphoma
Keywords
Advanced and/or Metastatic Solid Tumors and Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma
Primary Outcome Measure Information:
Title
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
Title
and to determine the recommended Phase 2 dose of pegaspargase
Secondary Outcome Measure Information:
Title
The secondary objectives of this study are to evaluate the safety and tolerability of the combination study treatment
Title
to determine the PD/PK profile and immunogenicity of pegaspargase
Title
to determine the PK profile of gemcitabine when administered in combination with pegaspargase
Title
and to detect preliminary evidence of tumor

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
TGen Clinical Research Services at Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-8511
Country
United States
Facility Name
Cancer Therapy & Research Center, Institute for Drug Development
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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