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Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00600002
First received: January 17, 2008
Last updated: August 11, 2009
Last verified: August 2009
History of Changes
  Purpose

The application of immunotherapeutic strategies that target the most potent antigen presenting cell, the DC, are likely to substantially increase the magnitude of the anti-tumor immune response. Although there are issues of activation state and antigen load, mechanisms to increase the number of DCs available to the immune system are among the first steps in development of affective DC based immunotherapeutic strategies. The Central Hypothesis of our study is: Administration of GM-CSF to patients with pancreatic adenocarcinoma will result in enhance recruitment of DCs to the sentinel lymph node, into the peripheral blood, and/or tumor site. We propose performing a phase I, dose escalation, clinical trial of systemic and intra-tumoral GM-CSF administration for the treatment of pancreatic adenocarcinoma. This trial will be designed to assess toxicity and immunologic effects, principally dendritic cell recruitment. Patients with resectable pancreatic adenocarcinoma by clinical staging criteria will be eligible for enrollment.

The trial we propose is a phase I clinical trial of the addition of GM-CSF as a biological adjuvant to standard care for patients with potentially resectable pancreatic adenocarcinoma.


Condition Intervention Phase
Resectable Pancreatic Adenocarcinoma
 Biological: GM-CSF
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial of GM-CSF Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Evaluate the toxicity, immune system status, quality of life, and potential clinical benefit of systemic GM-CSF administration in patients with pancreatic adenocarcinoma. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Primary endpoints: toxicity, dendritic cell recruitment, and immune parameters. Additional Recorded Observations: patient survival, progression free survival, time to treatment failure, quality of life, and biochemical markers. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: June 2004
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: GM-CSF
    Cohorts 1, 2, and 3 will be treated with systemic, intravenous (IV), administration of GM-CSF at 50, 150 and 250 ug/m2 doses respectively. Cohorts 4 through 7 will have intra-tumoral administration by EUS guided injections. As there is no clinical experience with pancreatic intra-tumoral injection of GM-CSF, we will follow a strict phase one design with cohort 4 receiving vehicle alone. Cohorts 5, 6, and 7 will receive GM-CSF at 50, 150 and 250 ug/ m2 doses respectively. In this Phase I trial, enrollment into any single cohort will be aborted if a grade IV (life threatening) toxicity is observed in two patients. Previous experience in breast cancer patients with systemic administration of GM-CSF at doses higher than those proposed here suggests that no Grade IV toxicity will be observed in cohorts 1 through 3. The maximum tolerated dose (MTD) for each route of administration will be defined as that dose above which...
  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 histological proven adenocarcinoma of the pancreas with potentially resectable disease based upon clinical staging.
  2. Expected survival must be greater than three (3) months.
  3. A Karnofsky Performance Status (KPS) must be 70 or greater (Appendix I).
  4. Patients must be >18 years of age. Because Leukine® is a "Pregnancy Category C" drug, female patients must be not be lactating and must be surgically sterile (via hysterectomy or bilateral tubal ligation), postmenopausal, or using acceptable methods of contraception if they are of child bearing potential. Female patients of childbearing potential must also have a negative serum pregnancy test.
  5. Patients must be able to understand and sign an informed consent form, which must comply with U.S. regulations (U.S. 21 CFR 50) and ICH guidelines. Availability of alternative curative treatment must be fully explained to the patient and documented in the informed consent form.

  6. Eligible patients must meet the following laboratory parameters:

    • WBC >3,000/mm3
    • Platelets >100,000/mm3
    • Hct >33% or Hgb >10.5 gm/dL
    • Prothrombin time (PT) within 3 seconds of control
    • Serum creatinine <1.5 mg/dL
    • Serum calcium <11.0 mg/dL
    • Serum Amylase < 2 times the upper limit of normal
    • Negative HIV-Ag and HIV-Ab

Exclusion Criteria:

  1. Patients who have undergone previous treatment with a biological response modifier (interferons, interleukins) or prior immunotherapy within four (4) weeks of study enrollment.
  2. Patients currently requiring corticosteroids, under immune suppression for any reason including an organ allograft.
  3. Patients with known contraindications to analgesia or endoscopy.
  4. Patients with unstable cardiovascular disease (Class IV cardiovascular disease according to the New York Heart Association's functional criteria, Appendix II).
  5. Patients with any acute or chronic illness as judged clinically significant by the Investigators.
  6. Patients who have received prior chemotherapy or radiation therapy to the thorax within four (4) weeks of enrollment.
  7. Prior surgery within 30 days of execution of the informed consent form.
  8. Persistent fever greater than 39C unless clinical assessment attributes the etiology to be tumor.
  9. Primary malignancy (present or remote) of sites other than the pancreas, except for the basal cell epithelioma of the skin.
  10. Use of investigational drugs within 30 days of execution of the informed consent form.
  11. Clinically significant (symptomatic) third space fluid collection (i.e.: ascites, pleural effusion).
  12. Patients with a diagnosis of an autoimmune state, or any psychiatric illness that in the opinion of the Investigators would compromise treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600002

Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Bayer
Investigators
Principal Investigator: Edward L Nelson, M.D. Chao Family Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Edward L. Nelson, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00600002     History of Changes
Other Study ID Numbers: UCI 02-69, HS#2003-2972
Study First Received: January 17, 2008
Last Updated: August 11, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous

ClinicalTrials.gov processed this record on May 19, 2013