Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurrent, Primary, or Metastatic Liver Cancer

Conditions:Breast Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Liver Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Age Range:18 - 75
Start Date:October 2007

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Phase I/II Study of Autologous Tumor Cell Vaccination Using Metronomic Cyclophosphamide, 3-Dimensional Conformal Radiotherapy, Intra/Peri-Tumor Injection of Poly ICLC With Trans-Hepatic Arterial Embolization Followed by Poly ICLC Boosting in Patients With Unresectable, Recurrent, or Metastatic Cancers in the Liver (Hepatoma, Cholangiocarcinoma, Neuroendocrine, Breast, Colon, Gastric, and Esophageal Cancer)

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill
tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly
to the tumor may kill more tumor cells and cause less damage to normal tissue. Poly ICLC may
stop the growth of liver cancer by blocking blood flow to the tumor. Giving the drug
directly into the arteries around the tumor may kill more tumor cells. Giving
cyclophosphamide and radiation therapy together with poly ICLC may be an effective treatment
for liver cancer.

PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide,
radiation therapy, and poly ICLC together and to see how well they work in treating patients
with unresectable, recurrent, primary, or metastatic liver cancer.


- 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 receive low-dose oral cyclophosphamide once daily on days 1-21 and undergo
3-dimensional conformal radiotherapy on days 21-23. On day 24, 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. Patients receive poly ICLC subcutaneously on days 26, 35, 37, 42, 44, 49,
and 51. Treatment repeats every 57 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.


- Radiologically or histologically confirmed hepatocellular carcinoma

- Stage III or IV primary disease

- Recurrent, unresectable, or metastatic disease meeting any of the following

- Pancreatic cancer that underwent prior surgical resection and progressed
with recurrent metastatic disease to the liver

- Gastric, colon, breast, or ovarian cancer or melanoma with 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

- Single lesion > 6.5 cm

- Three or more tumors > 4.5 cm

- Cumulative tumor diameter > 8 cm


- Karnofsky performance status 60-100%

- ANC ≥ 1,500/mm³

- Platelets ≥ 75,000/mm³

- Creatinine ≤ 1.7 mg/dL

- Total bilirubin ≤ 1.5 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

- LVEF ≥ 50%


- See Disease Characteristics

- No concurrent steroids
We found this trial at
Newark, New Jersey 07103
Newark, NJ
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