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| Sponsored by: |
St. Vincent Medical Center - Los Angeles |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002773 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Biological: allogeneic tumor cell vaccine Biological: recombinant interferon alfa Biological: sargramostim Drug: cyclophosphamide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
| Study Start Date: | December 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| St. Vincent Medical Center - Los Angeles | |
| Los Angeles, California, United States, 90057 | |
| Study Chair: | Charles L. Wiseman, MD, FACP | St. Vincent Medical Center - Los Angeles |
More Information
| Study ID Numbers: | CDR0000064749, SVMC-ONC-222P, NCI-V96-0886 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002773 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
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Interferon-alpha Interferon Type I, Recombinant Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Interferons Endocrine System Diseases Cyclophosphamide Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Pancrelipase |
Recurrence Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Antineoplastic Agents, Alkylating Endocrinopathy Antirheumatic Agents Adenocarcinoma Interferon Alfa-2a Alkylating Agents Endocrine Gland Neoplasms |
|
Anti-Infective Agents Interferon Type I, Recombinant Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Cyclophosphamide Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Alkylating Agents Endocrine Gland Neoplasms Interferon-alpha |
Digestive System Neoplasms Growth Substances Interferons Endocrine System Diseases Antiviral Agents Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Myeloablative Agonists Pancreatic Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Interferon Alfa-2a |
