Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/13/2018 |
| Start Date: | June 2004 |
| End Date: | April 2018 |
A Phase I Clinical Trial of GM-CSF Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma
The application of immunotherapeutic strategies that target the most potent antigen
presenting cell, the dendritic cell (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 Granulocyte Macrophage Colony Stimulating
Factor (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.
presenting cell, the dendritic cell (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 Granulocyte Macrophage Colony Stimulating
Factor (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.
Inclusion Criteria:
- Patients must have histological proven adenocarcinoma of the pancreas with potentially
resectable disease based upon clinical staging.
- Expected survival must be greater than three (3) months.
- A Karnofsky Performance Status (KPS) must be 70 or greater.
- 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.
- Patients must be able to understand and sign an informed consent form, which must
comply with U.S. regulations (U.S. 21 Code of Federal Regulations (CFR) 50) and
International Conference on Harmonisation (ICH) guidelines. Availability of
alternative curative treatment must be fully explained to the patient and documented
in the informed consent form.
- Eligible patients must meet the following laboratory parameters:
- White blood cell (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:
- Patients who have undergone previous treatment with a biological response modifier
(interferons, interleukins) or prior immunotherapy within four (4) weeks of study
enrollment.
- Patients currently requiring corticosteroids, under immune suppression for any reason
including an organ allograft.
- Patients with known contraindications to analgesia or endoscopy.
- Patients with unstable cardiovascular disease (Class IV cardiovascular disease
according to the New York Heart Association's functional criteria).
- Patients with any acute or chronic illness as judged clinically significant by the
Investigators.
- Patients who have received prior chemotherapy or radiation therapy to the thorax
within four (4) weeks of enrollment.
- Prior surgery within 30 days of execution of the informed consent form.
- Persistent fever greater than 39 degrees Celsius unless clinical assessment attributes
the etiology to be tumor.
- Primary malignancy (present or remote) of sites other than the pancreas, except for
the basal cell epithelioma of the skin.
- Use of investigational drugs within 30 days of execution of the informed consent form.
- Clinically significant (symptomatic) third space fluid collection (i.e.: ascites,
pleural effusion).
- Patients with a diagnosis of an autoimmune state, or any psychiatric illness that in
the opinion of the Investigators would compromise treatment.
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