Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer

Johns Hopkins Medicine

Status and phase: Terminated; Early Phase 1

Conditions: Cancer

Treatments: Device: Cryoablation; Drug: cyclophosphamide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00499733

CDR0000554417 (Other Identifier)

NA_00003073 (Other Identifier)

P30CA006973 (U.S. NIH Grant/Contract)

J0685

JHOC-J0685

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Drug: cyclophosphamide

Device: Cryoablation