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

Primary Purpose

Breast Cancer, Colorectal Cancer, Gastric Cancer

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

cyclophosphamide

poly ICLC

hepatic artery embolization

3-dimensional conformal radiation therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rutgrers University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

poly ICLC

Arm Description

Outcomes

Primary Outcome Measures

Overall tolerability

Secondary Outcome Measures

Progression-free survival at 6, 12, and 24 months

Overall survival at 6, 12, and 24 months

Full Information

NCT ID

NCT00553683

First Posted

November 2, 2007

Last Updated

January 11, 2014

Sponsor

Rutgers, The State University of New Jersey

1. Study Identification

Unique Protocol Identification Number

NCT00553683

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2007 (undefined)

Primary Completion Date

February 2014 (Anticipated)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Colorectal Cancer, Gastric Cancer, Liver Cancer, Melanoma (Skin), Metastatic Cancer, Ovarian Cancer, Pancreatic Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

poly ICLC

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

poly ICLC

Intervention Type

Procedure

Intervention Name(s)

hepatic artery embolization

Intervention Type

Radiation

Intervention Name(s)

3-dimensional conformal radiation therapy

Primary Outcome Measure Information:

Title

Overall tolerability

Time Frame

up to 90 days

Secondary Outcome Measure Information:

Title

Progression-free survival at 6, 12, and 24 months

Time Frame

up to 24 months

Title

Overall survival at 6, 12, and 24 months

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew N. de la Torre, MD

Organizational Affiliation

UMDNJ University Hospital / St Joseph Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Rutgrers University Hospital

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07101

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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