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

Phase 1

• Conditions: Breast Cancer; Colorectal Cancer; Gastric Cancer; Liver Cancer; Melanoma (Skin); Metastatic Cancer; Ovarian Cancer; Pancreatic Cancer
• Interventions: Drug: cyclophosphamide; Drug: poly ICLC; Procedure: hepatic artery embolization; Radiation: 3-dimensional conformal radiation therapy

• Registration Number: NCT00553683
• Lead Sponsor: 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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-11
• Last Update Posted: 2014-01-14
• Primary Completion: 2014-02
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
poly ICLC	hepatic artery embolization	-
poly ICLC	3-dimensional conformal radiation therapy	-
poly ICLC	cyclophosphamide	-
poly ICLC	poly ICLC	-

Primary Outcome Measures

Name	Time	Method
Overall tolerability	up to 90 days

Secondary Outcome Measures

Name	Time	Method
Overall survival at 6, 12, and 24 months	up to 24 months
Progression-free survival at 6, 12, and 24 months	up to 24 months

Trial Locations

Locations (1)

Rutgrers University Hospital; 🇺🇸 Newark, New Jersey, United States