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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Charles L. Wiseman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

St. Vincent Medical Center - Los Angeles

Authority:

United States: Federal Government

Study ID:

CDR0000064749

NCT ID:

NCT00002773

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

St. Vincent Medical Center - Los AngelesLos Angeles, California  90057