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Chemotherapy Compared to Biological Therapy in Treating Patients With Cancer of the Pancreas

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tumor infiltrating lymphocyte therapy
gemcitabine hydrochloride
Sponsored by
Meyer Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven stage II, III, or IV pancreatic cancer that is unresectable No symptomatic third space fluid collection (e.g., ascites, pleural effusion) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 33% Hemoglobin at least 10.5 g/dL Hepatic: Bilirubin no greater than 3.0 mg/dL SGOT or SGPT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No history of myocardial infarction within past 3 months No congestive heart failure Other: HIV negative No other prior malignancy except basal cell skin cancer No persistent fever greater than 102 degrees F (39 degrees C) unless caused by the pancreatic cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy (e.g., interferons, interleukins) Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent systemic steroids Radiotherapy: No prior radiotherapy Surgery: At least 30 days since prior surgery Decompressive surgery and endoscopic stenting (including expandable wire stents) allowed to relieve symptoms of disease Other: At least 30 days since prior investigational therapy Palliative care to relieve symptoms of disease allowed, including pain management and celiac block by endoscopic ultrasonography or percutaneously

Sites / Locations

  • Meyer Pharmaceuticals, LLC

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 18, 2013
Sponsor
Meyer Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00003780
Brief Title
Chemotherapy Compared to Biological Therapy in Treating Patients With Cancer of the Pancreas
Official Title
An Open Label Randomized Trial Comparing the Safety and Efficacy of Systemic Chemotherapy (Gemcitabine) to Immunotherapy (CYTOIMPLANT - Intra Tumor Implants of Allogeneic Peripheral Blood Mononuclear Cells Sensitized Against Patient Alloantigens by Mixed Lymphocyte Culture) as First Line Therapy for Patients With Unresectable Locally Advanced, and Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Meyer Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known whether chemotherapy is more effective than biological therapy in treating patients with cancer of the pancreas. PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine with biological therapy in treating patients who have cancer of the pancreas that cannot be surgically removed.
Detailed Description
OBJECTIVES: I. Compare the efficacy of CYTOIMPLANT (intratumor implants of allogeneic peripheral blood mononuclear cells sensitized against patient alloantigens by mixed lymphocyte culture) vs gemcitabine in patients with unresectable, locally advanced or metastatic pancreatic cancer. II. Compare the overall survival, progression free survival, objective tumor response, time to treatment failure, and quality of life of these patients. III. Compare the safety and toxicities of CYTOIMPLANT vs gemcitabine in these patients. OUTLINE: This is a randomized, open label, multicenter study. Patients are randomly assigned (2:1 ratio in favor of CYTOIMPLANT arm) to one of two treatment arms. Arm I: Patients receive gemcitabine IV weekly for 7 weeks, followed by 1 week of rest. In subsequent courses, patients then receive gemcitabine IV weekly for 3 weeks followed by a week of rest. Courses are repeated every 4 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients undergo leukapheresis to collect lymphocytes. Patient lymphocytes are mixed with donor lymphocytes at the sponsor labs. The mixture is implanted into the tumor using endoscopic ultrasound guided fine needle injection. This process may be repeated in the fifth month using different donor's lymphocytes. Follow up assessments may include physical exams, lab tests, CT scans, and quality of life assessments at 4 weeks and at 3, 5, 7, 9, and 12 months from the date of randomization. Patients are then contacted every 3 months to assess status. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
tumor infiltrating lymphocyte therapy
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven stage II, III, or IV pancreatic cancer that is unresectable No symptomatic third space fluid collection (e.g., ascites, pleural effusion) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 33% Hemoglobin at least 10.5 g/dL Hepatic: Bilirubin no greater than 3.0 mg/dL SGOT or SGPT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No history of myocardial infarction within past 3 months No congestive heart failure Other: HIV negative No other prior malignancy except basal cell skin cancer No persistent fever greater than 102 degrees F (39 degrees C) unless caused by the pancreatic cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy (e.g., interferons, interleukins) Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent systemic steroids Radiotherapy: No prior radiotherapy Surgery: At least 30 days since prior surgery Decompressive surgery and endoscopic stenting (including expandable wire stents) allowed to relieve symptoms of disease Other: At least 30 days since prior investigational therapy Palliative care to relieve symptoms of disease allowed, including pain management and celiac block by endoscopic ultrasonography or percutaneously
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael F. O'Neill
Organizational Affiliation
Meyer Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Meyer Pharmaceuticals, LLC
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States

12. IPD Sharing Statement

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Chemotherapy Compared to Biological Therapy in Treating Patients With Cancer of the Pancreas

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