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

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ClinicalTrials.gov 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 5, 2007
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Andrew de la Torre, Rutgers, The State University of New Jersey

November 2, 2007
November 5, 2007
January 14, 2014
October 2007
February 2014   (Final data collection date for primary outcome measure)
Overall tolerability [ Time Frame: up to 90 days ]
  • Tumor response on CT scan
  • Progression-free survival at 6, 12, and 24 months
  • Overall survival at 6, 12, and 24 months
Complete list of historical versions of study NCT00553683 on ClinicalTrials.gov Archive Site
  • Progression-free survival at 6, 12, and 24 months [ Time Frame: up to 24 months ]
  • Overall survival at 6, 12, and 24 months [ Time Frame: up to 24 months ]
Not Provided
Not Provided
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Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurrent, Primary, or Metastatic Liver Cancer
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.

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 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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Experimental: poly ICLC
Interventions:
  • Drug: cyclophosphamide
  • Drug: poly ICLC
  • Procedure: hepatic artery embolization
  • Radiation: 3-dimensional conformal radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
40
July 2014
February 2014   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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%

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent steroids
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00553683
CDR0000573370
UMDNJ-0120070076
Not Provided
Not Provided
Not Provided
Andrew de la Torre, Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
Not Provided
Study Chair: Andrew N. de la Torre, MD UMDNJ University Hospital / St Joseph Medical Center
Rutgers, The State University of New Jersey
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP