3-Dimensional Conformal Radiation Therapy, Arterial Embolization, and Tumor Cell Vaccine in Treating Patients With Unresectable, Recurrent, or Metastatic Primary Liver Cancer or Pancreatic Cancer - NCT00553683-07101(Clinical Trial 189773)
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Newark |
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State:
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NJ |
| Zip Code: |
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07101 |
| Conditions: |
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Liver Cancer - Pancreatic Cancer |
| Purpose: |
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RATIONALE: Giving radiation therapy that uses a 3-dimensional image of the tumor to help
focus thin beams of radiation directly on the tumor may kill more tumor cells and have fewer
side effects. Vaccines made from a person's tumor cells may help the body build an effective
immune response to kill tumor cells. Liver arterial embolization kills tumor cells by
blocking the blood flow to the tumor and keeping the vaccine near the tumor. Giving
3-dimensional conformal radiation therapy together with tumor cell vaccine and arterial
embolization may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving 3-dimensional
conformal radiation therapy together with arterial embolization and tumor cell vaccine and
to see how well it works in treating patients with unresectable, recurrent, or metastatic
primary liver cancer or pancreatic cancer.
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| Study summary: |
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OBJECTIVES:
- To study the safety and effectiveness of a strategy to establish robust anticancer
immunologic body defenses by using low-dose radiation therapy to the liver cancer in
order to increase tumor targetability; inject a body defense activator,
polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC, hiltonol,
oncovir), into and around the cancer to activate sentinel dendritic cells to alarm body
defenses; and shut down local production of factors that suppress the body's natural
anticancer defenses by starving the cancer of its blood supply within the liver.
OUTLINE: Patients undergo 3-dimensional conformal radiotherapy on days 1-3. On day 4
patients undergo an intra- or peri-tumoral polyinosinic-polycytidylic acid polylysine
carboxymethylcellulose (poly ICLC) injection directly into the tumor followed by
trans-hepatic artery embolization to the designated tumor on day 5. Patients receive poly
ICLC subcutaneously on days 6, 15, 17, 22, 24, 29, and 31. Treatment repeats every 33 days
for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months thereafter. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Radiologically or histologically confirmed primary hepatocellular carcinoma or
histologically confirmed pancreatic carcinoma with liver metastasis
- Stage III or IV disease
- Recurrent, unresectable or metastatic disease meeting any of the following
criteria:
- Initially presented with metastatic pancreatic cancer in the liver
- Pancreatic cancer that underwent prior surgical resection and progressed
with recurrent metastatic disease to the liver
- Primary or recurrent disease that cannot be surgically resected leaving the
patient disease-free
- Radiologically measurable disease
- Ineligible for liver transplantation according to University of San Francisco listing
criteria:
- Single lesion > 6.5 cm
- Three or more tumors > 4.5 cm
- Cumulative tumor diameter > 8 cm
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- ANC ≥ 1500/mm³
- Platelets ≥ 75,000/mm³
- Creatinine ≤ 1.7 mg/dL
- Total bilirubin ≤ 1.7 mg/dL
- AST and ALT ≤ 3 times the upper limit of normal
- INR < 1.5
- LVEF ≥ 50%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious concurrent infection or medical illness that would render the protocol
treatment unsafe
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent steroids |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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October 7, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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