NCT00499733

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at P50-P75 for early_phase_1 cancer

Timeline
Completed

Started Jun 2007

Longer than P75 for early_phase_1 cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2013

Completed
Last Updated

January 18, 2019

Status Verified

February 1, 2017

Enrollment Period

3.1 years

First QC Date

July 10, 2007

Last Update Submit

January 16, 2019

Conditions

Cancer

Keywords

carcinoma of unknown primaryrecurrent carcinoma of unknown primarystage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancerextensive stage small cell lung cancerrecurrent small cell lung cancerstage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancermale breast cancerrecurrent breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerchondrosarcomametastatic osteosarcomarecurrent osteosarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcomarecurrent adult soft tissue sarcomapreviously treated childhood rhabdomyosarcomarecurrent childhood rhabdomyosarcomametastatic childhood soft tissue sarcomarecurrent childhood soft tissue sarcomaovarian sarcomastage IIIB uterine sarcomastage IIIC uterine sarcomastage IIIA uterine sarcomastage IVA uterine sarcomastage IVB uterine sarcomametastatic Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumorstage III colon cancerstage IV colon cancerrecurrent colon cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancerrecurrent childhood liver cancerstage III childhood liver cancerstage IV childhood liver cancerstage III pancreatic cancerlocalized osteosarcomamalignant giant cell tumor of bonestage IV melanomarecurrent melanomastage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage III basal cell carcinoma of the lipstage III squamous cell carcinoma of the lip and oral cavitystage III verrucous carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent verrucous carcinoma of the oral cavitymetastatic squamous neck cancer with occult primary squamous cell carcinomarecurrent metastatic squamous neck cancer with occult primaryuntreated metastatic squamous neck cancer with occult primarystage III squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityhigh-grade salivary gland mucoepidermoid carcinomasalivary gland adenocarcinomasalivary gland adenoid cystic carcinomasalivary gland anaplastic carcinomasalivary gland malignant mixed cell type tumorsalivary gland poorly differentiated carcinomasalivary gland squamous cell carcinomalow-grade salivary gland mucoepidermoid carcinomasalivary gland acinic cell tumorstage III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland cancerintraocular lymphomarecurrent childhood lymphoblastic lymphomarecurrent pancreatic cancerrecurrent uterine sarcomanewly diagnosed carcinoma of unknown primaryadvanced adult primary liver cancerciliary body and choroid melanoma, medium/large sizeconjunctival melanomastage IV pancreatic cancerstage IIIA melanomastage IIIB melanomastage IIIC melanomatongue cancerstage IIIA intraocular melanomastage IIIB intraocular melanomastage IIIC intraocular melanomastage IV intraocular melanoma

Outcome Measures

Primary Outcomes (1)

  • Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity

    Two years

Secondary Outcomes (1)

  • Tumor response, according to RECIST criteria

    Two years

Study Arms (1)

Intervention

EXPERIMENTAL

Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery.

Drug: cyclophosphamideDevice: Cryoablation

Interventions

cyclophosphamideDRUG

500 mg/m\^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.

Also known as: cytoxan
Intervention
CryoablationDEVICE

Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.

Intervention

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of epithelial solid tumors of any of the following sites or types: * Lung (closed to accrual as of 4/2/2009) * Renal * Prostate * Breast (closed to accrual as of 4/2/2009) * Sarcoma (closed to accrual as of 4/2/2009) * Colon (closed to accrual as of 4/2/2009) * Liver(closed to accrual as of 4/2/2009) * Pancreatic (closed to accrual as of 4/2/2009) * Bone (closed to accrual as of 4/2/2009) * Head and neck (closed to accrual as of 4/2/2009) * Melanoma (closed to accrual as of 4/2/2009) * Carcinoma of unknown primary (closed to accrual as of 4/2/2009) * Advanced or metastatic disease * Ineligible for or unwilling to undergo surgical resection * Eligible for cryotherapy but not expected to be cured by cryotherapy alone PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * Creatinine \< 2.5 mg/dL * Platelet count \>75,000/mm³ * INR\< 1.5 * No known HIV positivity * No active, uncontrolled infection * Not pregnant * Negative pregnancy test * Women of childbearing potential must practice adequate contraception * No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Brady Urological Institute at Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

NeoplasmsNeoplasms, Unknown PrimaryCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaCarcinoma, Renal CellProstatic NeoplasmsBreast Neoplasms, MaleBreast NeoplasmsChondrosarcomaOsteosarcomaSarcomaNeuroectodermal Tumors, Primitive, PeripheralColonic NeoplasmsCarcinoma, HepatocellularPancreatic NeoplasmsMelanomaSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland NeoplasmsIntraocular LymphomaUveal MelanomaTongue Neoplasms

Interventions

CyclophosphamideCryosurgery

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesLiver NeoplasmsLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesNeuroendocrine TumorsNevi and MelanomasSkin NeoplasmsCarcinoma, Squamous CellHead and Neck NeoplasmsNeuroblastomaOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesLymphomaEye NeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesUveal NeoplasmsEye DiseasesUveal DiseasesTongue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Ronald Rodriguez, MD, PhD

    Brady Urological Institute at Johns Hopkins Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

June 1, 2007

Primary Completion

July 1, 2010

Study Completion

January 9, 2013

Last Updated

January 18, 2019

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)