Phase I/II Intratumoral DC Immunotherapy With Gemcitabine & XRT in Unresectable Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier:
NCT00547144
First received: October 18, 2007
Last updated: November 6, 2012
Last verified: August 2012
  Purpose

To determine the safety, feasibility and appropriate dendritic cell dose to vaccinate patients with pancreas cancer


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine
Procedure: Dendritic Cell Immunotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Intratumoral Dendritic Cell Immunotherapy in Combination With Gemcitabine and Stereotactic Radiosurgery in Unresectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • o evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells. [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Phase II: To determine the overall response rate for this regimen as determined by radiographic criteria. [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Phase I: To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with gemcitabine and stereotactic radiosurgery [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • To determine the time to tumor progression for this regimen. [ Time Frame: unknown ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: October 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine Drug: Gemcitabine
1000 mg/m2 intravenoulsy once a week according to protocol schedule
Other Name: Gemzar
Procedure: Dendritic Cell Immunotherapy
The cells will be administered by intratumoral injection on 2 different days(at least 21 days apart)
Other Names:
  • DC Therapy
  • Dendritic Cell Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1. Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas. The site of the primary lesion should be confirmed endoscopically, radiologically, or surgically to be in the pancreas.

2. Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.

3. Patients must have a primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study 4. More than 4 weeks must have elapsed from the time of major surgery or completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects.

5. Life expectancy of >3 months. 6. Karnofsky performance status >70%. 7. Patients must have normal organ and marrow functions as defined below: absolute neutrophil count >1,500/mm3 platelets >70,000/mm3 total bilirubin <1.5 mg/dL AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal creatinine within normal institutional limits OR creatinine clearance >60mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

albumin > 2.8 mg/dL 8. Patients must have adequate clotting function (platelet > 70k; INR<1.4; PTT<60).

9. Age >18 years. 10. The effects of DCs on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

11. No history of autoimmune diseases. 12. Ability to understand the study protocol and a willingness to sign a written informed consent document.

Exclusion Criteria:1. Patients receiving anticoagulation therapy. 2. Patients who have received prior gemcitabine or radiation therapy to the pancreatic bed 3. Patients receiving any other investigational agents. 4. Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse effects.

5. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.

6. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547144

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
George Albert Fisher
Investigators
Principal Investigator: Edgar G Engleman Stanford University
Principal Investigator: George Albert Fisher M.D. Ph.D. Stanford University
  More Information

No publications provided

Responsible Party: George Albert Fisher, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00547144     History of Changes
Obsolete Identifiers: NCT00568932
Other Study ID Numbers: PANC0003, 95935, 1454
Study First Received: October 18, 2007
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 20, 2014