Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurrent, Primary, or Metastatic Liver Cancer
Recruitment status was Recruiting
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Masking: 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) |
- Overall tolerability [ Designated as safety issue: No ]
- Liver function [ Designated as safety issue: No ]
- Autoimmunity [ Designated as safety issue: No ]
- Tumor response on CT scan [ Designated as safety issue: No ]
- Progression-free survival at 6, 12, and 24 months [ Designated as safety issue: No ]
- Overall survival at 6, 12, and 24 months [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New Jersey | |
| UMDNJ University Hospital | Recruiting |
| Newark, New Jersey, United States, 07101 | |
| Contact: Andrew N. de la Torre, MD 973-972-1258 delatoan@umdnj.edu | |
| Study Chair: | Andrew N. de la Torre, MD | University of Medicine and Dentistry New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | Andrew N. de la Torre, UMDNJ University Hospital |
| ClinicalTrials.gov Identifier: | NCT00553683 History of Changes |
| Other Study ID Numbers: | CDR0000573370, UMDNJ-0120070076 |
| Study First Received: | November 2, 2007 |
| Last Updated: | October 16, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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:
|
Breast Neoplasms Colorectal Neoplasms Liver Neoplasms Stomach Neoplasms Melanoma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Ovarian Neoplasms Pancreatic Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Liver Diseases Stomach Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes |
ClinicalTrials.gov processed this record on May 16, 2013