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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Michael F. O'Neill

Investigator Role:

Study Chair

Investigator Affiliation:

Meyer Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000066912

NCT ID:

NCT00003780

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Meyer Pharmaceuticals, LLCIrvine, California  92614