A Study Evaluating IV Oncaspar® and IV Gemzar® in the Treatment of Solid Tumors and Lymphoma - Full Text View

Sponsor:	Enzon Pharmaceuticals, Inc.
Information provided by:	Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00363610

Purpose

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®.

Condition	Intervention	Phase
Tumors Lymphoma	Drug: Oncaspar & Gemzar; advanced and/or solid tumors and lymphoma	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pegaspargase

U.S. FDA Resources

Further study details as provided by Enzon Pharmaceuticals, Inc.:

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

Enrollment:	19
Study Start Date:	July 2006
Estimated Study Completion Date:	June 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363610

Locations

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

Sponsors and Collaborators

Enzon Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	( Enzon Pharmaceuticals, Inc. )
Study ID Numbers:	EZ-002-001
Study First Received:	August 9, 2006
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00363610 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Enzon Pharmaceuticals, Inc.:

Advanced and/or Metastatic Solid Tumors and Lymphoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Lymphatic Diseases
Pegaspargase
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Lymphoproliferative Disorders
Gemcitabine
Lymphoma

ClinicalTrials.gov processed this record on November 09, 2009