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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)


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Breast Cancer, Colorectal Cancer, Gastric Cancer, Liver Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Pancreatic Cancer

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Trial Information

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)


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall tolerability

Safety Issue:

No

Principal Investigator

Andrew N. de la Torre, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Medicine and Dentistry New Jersey

Authority:

Unspecified

Study ID:

CDR0000573370

NCT ID:

NCT00553683

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Gastric Cancer
  • Liver Cancer
  • Melanoma (Skin)
  • Metastatic Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • 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
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Stomach Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Ovarian Neoplasms
  • Pancreatic Neoplasms

Name

Location

UMDNJ University HospitalNewark, New Jersey  07103