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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00553683
Recruitment Status : Unknown
Verified January 2014 by Andrew de la Torre, Rutgers, The State University of New Jersey.
Recruitment status was:  Active, not recruiting
First Posted : November 4, 2007
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
Andrew de la Torre, Rutgers, The State University of New Jersey

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Gastric Cancer Liver Cancer Melanoma (Skin) Metastatic Cancer Ovarian Cancer Pancreatic Cancer Drug: cyclophosphamide Drug: poly ICLC Procedure: hepatic artery embolization Radiation: 3-dimensional conformal radiation therapy Phase 1 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2007
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: poly ICLC Drug: cyclophosphamide
Drug: poly ICLC
Procedure: hepatic artery embolization
Radiation: 3-dimensional conformal radiation therapy

Primary Outcome Measures :
  1. Overall tolerability [ Time Frame: up to 90 days ]

Secondary Outcome Measures :
  1. Progression-free survival at 6, 12, and 24 months [ Time Frame: up to 24 months ]
  2. Overall survival at 6, 12, and 24 months [ Time Frame: up to 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Radiologically or histologically confirmed hepatocellular carcinoma

    • Stage III or IV primary disease
    • Recurrent, unresectable, or metastatic disease meeting any of the following criteria:

      • 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 criteria:

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553683

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United States, New Jersey
Rutgrers University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
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Study Chair: Andrew N. de la Torre, MD UMDNJ University Hospital / St Joseph Medical Center
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Responsible Party: Andrew de la Torre, Associate Professor, Rutgers, The State University of New Jersey Identifier: NCT00553683    
Other Study ID Numbers: CDR0000573370
First Posted: November 4, 2007    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Andrew de la Torre, Rutgers, The State University of New Jersey:
stage IV pancreatic cancer
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
recurrent adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent pancreatic cancer
recurrent colon cancer
recurrent breast cancer
recurrent gastric cancer
recurrent ovarian epithelial cancer
recurrent melanoma
stage IV breast cancer
stage IV gastric cancer
stage IV colon cancer
stage IV ovarian epithelial cancer
stage IV melanoma
liver metastases
Additional relevant MeSH terms:
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Breast Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Liver Diseases
Neoplastic Processes
Immunosuppressive Agents