Official Title: “A CLINICAL TRIAL FOR PANCREAS CANCER USING ACTIVE INTRALYMPHATIC IMMUNOTHERAPY WITH INTERFERON-TREATED PANCREAS CANCER TISSUE CULTURE CELLS, GMCSF, AND LOW-DOSE CYCLOPHOSPHAMIDE”

RATIONALE: Vaccines made from donated tumor cells treated with interferon alfa may make the body build an immune response to and kill pancreatic tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Colony-stimulating factors may help a person's immune system recover from the side effects of chemotherapy. Combining these treatments may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy using donated tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide plus GM-CSF in treating patients with advanced pancreatic cancer.

Study Type: Interventional

Study Design: Treatment

OBJECTIVES: I. Determine the feasibility, toxicity, and antitumor effects of active specific intralymphatic immunotherapy with allogeneic pancreatic cancer cells treated with interferon alfa plus low-dose adjuvant systemic sargramostim (GM-CSF) and cyclophosphamide in patients with incurable pancreatic adenocarcinoma. II. Assess the immunologic and biologic correlates of this treatment regimen in these patients.

OUTLINE: Cultured allogeneic pancreatic cancer cells are incubated with interferon alfa for 72-96 hours. Autologous cell lines, if established, may be used as an alternative. The cells are irradiated immediately prior to use. Patients receive cyclophosphamide IV on day -3 and sargramostim (GM-CSF) subcutaneously on days 0-8. On day 0, patients receive viable tumor cells via dorsal pedal lymphatic cannulation. Treatment repeats every 2-4 weeks for a minimum of 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-4 months.

PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Drug: cyclophosphamide
• Drug: recombinant interferon alfa
• Drug: sargramostim
• Procedure: tumor cell-derivative vaccine therapy

• DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas that is locoregionally active or metastatic and not amenable to cure or long-term control by surgery, radiotherapy, or chemotherapy No brain metastases refractory to irradiation or surgery
• PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 OR Karnofsky 60-100%
• Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified
• Renal: Not specified Cardiovascular: No prior or concurrent significant cardiovascular disease Pulmonary: No prior or concurrent significant pulmonary disease Other: No AIDS HIV negative No prior or concurrent autoimmune disease No other concurrent major medical illness Not pregnant or nursing Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
• Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent chronic steroid therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other prior therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: St. Vincent Medical Center - Los Angeles

Overall Clinical Trial Officials and Contacts

Charles L. Wiseman, MD, FACP Study Chair St. Vincent Medical Center - Los Angeles  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002773

Study ID Number: CDR0000064749

ClinicalTrials.gov Identifier: NCT00002773

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database