Clinical trial NCT00499733: Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
Official title: Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Cancer
Keywords: carcinoma of unknown primary
recurrent carcinoma of unknown primary
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer
male breast cancer
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
chondrosarcoma
metastatic osteosarcoma
recurrent osteosarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
previously treated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
metastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
ovarian sarcoma
stage IIIB uterine sarcoma
stage IIIC uterine sarcoma
stage IIIA uterine sarcoma
stage IVA uterine sarcoma
stage IVB uterine sarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
stage III colon cancer
stage IV colon cancer
recurrent colon cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
recurrent childhood liver cancer
stage III childhood liver cancer
stage IV childhood liver cancer
stage III pancreatic cancer
localized osteosarcoma
malignant giant cell tumor of bone
stage IV melanoma
recurrent melanoma
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage III basal cell carcinoma of the lip
stage III squamous cell carcinoma of the lip and oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent verrucous carcinoma of the oral cavity
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary
untreated metastatic squamous neck cancer with occult primary
stage III squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
high-grade salivary gland mucoepidermoid carcinoma
salivary gland adenocarcinoma
salivary gland adenoid cystic carcinoma
salivary gland anaplastic carcinoma
salivary gland malignant mixed cell type tumor
salivary gland poorly differentiated carcinoma
salivary gland squamous cell carcinoma
low-grade salivary gland mucoepidermoid carcinoma
salivary gland acinic cell tumor
stage III salivary gland cancer
stage IV salivary gland cancer
recurrent salivary gland cancer
intraocular lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent pancreatic cancer
recurrent uterine sarcoma
newly diagnosed carcinoma of unknown primary
advanced adult primary liver cancer
ciliary body and choroid melanoma, medium/large size
conjunctival melanoma
stage IV pancreatic cancer
stage IIIA melanoma
stage IIIB melanoma
stage IIIC melanoma
tongue cancer
stage IIIA intraocular melanoma
stage IIIB intraocular melanoma
stage IIIC intraocular melanoma
stage IV intraocular melanoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-07-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: OBJECTIVES:

* Document radiologic and/or tumor marker response to cryotherapy of tumor lesions followed by cyclophosphamide.

OUTLINE: This is a pilot study.

Patients undergo percutaneous biopsy of the targeted lesion prior to cryoablation. Patients then undergo percutaneous or open cryotherapy of the largest or most accessible lesion on day 0. On day 3, patients receive cyclophosphamide IV over 1 hour.

Tumor markers (if applicable) are assessed at baseline and monthly during study until marker progression.

After completion of study therapy, patients are followed periodically for up to 3 years.

Eligibility criteria: 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

Primary outcomes:
measure: Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
timeFrame: Two years
Secondary outcomes:
measure: Tumor response, according to RECIST criteria
timeFrame: Two years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Brady Urological Institute at Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Brady Urological Institute at Johns Hopkins Hospital
name: Ronald Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: