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

• Status: Unknown status
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Carboxymethylcellulose Sodium; Cyclophosphamide; Poly I-C; Poly ICLC

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