NCT00553683

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

6.3 years

First QC Date

November 2, 2007

Last Update Submit

January 11, 2014

Conditions

Breast CancerColorectal CancerGastric CancerLiver CancerMelanoma (Skin)Metastatic CancerOvarian CancerPancreatic Cancer

Keywords

stage IV pancreatic canceradult primary hepatocellular carcinomaadvanced adult primary liver cancerrecurrent adult primary liver cancerlocalized unresectable adult primary liver cancerrecurrent pancreatic cancerrecurrent colon cancerrecurrent breast cancerrecurrent gastric cancerrecurrent ovarian epithelial cancerrecurrent melanomastage IV breast cancerstage IV gastric cancerstage IV colon cancerstage IV ovarian epithelial cancerstage IV melanomaliver metastases

Outcome Measures

Primary Outcomes (1)

  • Overall tolerability

    up to 90 days

Secondary Outcomes (2)

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

    up to 24 months

  • Overall survival at 6, 12, and 24 months

    up to 24 months

Study Arms (1)

poly ICLC

EXPERIMENTAL
Drug: cyclophosphamideDrug: poly ICLCProcedure: hepatic artery embolizationRadiation: 3-dimensional conformal radiation therapy

Interventions

cyclophosphamideDRUG
poly ICLC
poly ICLCDRUG
poly ICLC
hepatic artery embolizationPROCEDURE
poly ICLC
3-dimensional conformal radiation therapyRADIATION
poly ICLC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Rutgrers University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsStomach NeoplasmsLiver NeoplasmsMelanomaNeoplasm MetastasisOvarian NeoplasmsPancreatic NeoplasmsCarcinoma, HepatocellularColonic NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Cyclophosphamidepoly ICLCRadiotherapy, Conformal

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesLiver DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Andrew N. de la Torre, MD

    UMDNJ University Hospital / St Joseph Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

October 1, 2007

Primary Completion

February 1, 2014

Study Completion

July 1, 2014

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

US(1)