Full Text View
Tabular View
No Study Results Posted
Related Studies
Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
First Received: August 8, 2007   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00514215
  Purpose

RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving an injection of GM-CSF before cryotherapy and inhaling GM-CSF after cryotherapy may interfere with the growth of tumor cells and shrink the tumor. Giving cryotherapy together with GM-CSF may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cryotherapy together with GM-CSF works in treating patients with lung metastases or primary lung cancer.


Condition Intervention Phase
Kidney Cancer
Lung Cancer
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Biological: sargramostim
Other: flow cytometry
Other: immunoenzyme technique
Procedure: biopsy
Procedure: cryosurgery
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Percutaneous Cryotherapy and Aerosolized GM-CSF for Pulmonary Metastases and Primary Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Immunologic response as measured by ELISPOT assay and flow cytometry [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response as measured by CT criteria [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Immune function and cancer-specific response [ Designated as safety issue: No ]

Estimated Enrollment: 17
Study Start Date: January 2006
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine whether percutaneous cryotherapy in combination with aerosolized sargramostim (GM-CSF) has any demonstrable immunologic effect in patients with pulmonary metastases or primary lung cancer.
  • Determine whether any systemic immune response is detectable by the combination of cryotherapy as the antigen presentation source and GM-CSF as the immunologic adjuvant.
  • Determine whether low morbidities will be maintained in patients treated with this regimen.
  • Determine whether effective immunization is associated with a drop in CD4+, CD25+, LTP(TGF-β1)+, Tr cells as measured by flow cytometry or ELISPOT assay for TGF-β1-secreting cells.

Secondary

  • Determine clinical response (i.e., tumor control in the dominant masses undergoing cryotherapy or in other metastatic sites) as measured by CT criteria.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Patients undergo CT-guided core biopsy of a dominant lung mass and placement of at least 2 cryoprobes.

Prior to initiating the freeze, patients receive an interstitial injection of sargramostim (GM-CSF) near the tumor. Patients then undergo percutaneous cryotherapy over 2 hours utilizing a freeze-thaw-freeze cycle.

Beginning within 3 days of cryotherapy, patients receive aerosolized GM-CSF twice daily for 1 week. Beginning on day 32, patients may elect to undergo a second course of treatment as described above in the absence of disease progression or unacceptable toxicity.

Patients undergo blood and tumor tissue collection at baseline and periodically during study for immunological correlative studies. Peripheral blood mononuclear cells isolated from blood samples are analyzed for antigen-specific CD4-positive or CD8-positive T-cell response by flow cytometry or by TGF-β1 ELISPOT assay to measure TGF-β1- secreting cells. Tumor cell lysates extracted from tumor samples are pulsed with autologous dendritic cells and analyzed by ELISPOT assay to measure T-cell reactivity in tumor specimens.

After completion of study therapy, patients are followed at 6 and 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Primary non-small cell lung cancer (NSCLC)

      • Any stage nonoperative NSCLC or patient refuses surgery
    • Any cancer with pulmonary metastatic disease (including renal cell cancer)

      • Stage IV disease (any T, any N, M1)
  • Must have 1-10 pulmonary or mediastinal masses meeting the following criteria:

    • At least 1 mass is appropriate for 2 sessions of core biopsy and cryotherapy with relatively easy access/low risk in nonoperative patients (or those refusing surgery)
    • The two dominant masses are defined as either the largest and/or those that may cause imminent morbidity from continued local progression, thereby potentially benefiting from thoracic cryotherapy alone
    • Optimal tumor size > 1.0 cm

      • Dominant masses up to 6 cm in diameter may be considered if thorough cryotherapy coverage can be anticipated with minimal additional treatment morbidity
  • Measurable disease, defined as tridimensional measurements of up to 6 different pulmonary or mediastinal masses ≥ 0.5 cm by CT scan
  • No active pleural effusion that could be related to respiratory infection or requires further work-up
  • No untreated and/or unstable brain metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Life expectancy ≥ 12 weeks
  • Granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 50,000/mm³
  • INR < 1.5 (i.e., normal PT/PTT)
  • Hemoglobin ≥ 8.0 g/dL
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Satisfactory pulmonary function test as determined by supervising oncologist, thoracic surgeon, or pulmonologist
  • Not pregnant or lactating
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix

    • Inactive history of cancer allowed if the patient has been disease-free for > 2 years
  • No serious medical or psychiatric illnesses that would preclude informed consent or limit survival to < 12 wks
  • No uncontrollable cough or inability to lie flat
  • No New York Heart Association class III or IV heart disease
  • No known immunodeficiency state
  • No uncontrolled infection
  • No uncontrolled coagulopathy or bleeding diathesis
  • No advance directive that would prevent the investigator from treating the participant in the event of a complication occurring during or after the procedure
  • No medical contraindication or potential problem that would preclude protocol compliance

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior biologic therapy
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • More than 4 weeks since prior radiotherapy
  • More than 2 weeks since prior corticosteroids
  • More than 1 week since prior parenteral antibiotics
  • At least 1 week since prior aspirin or aspirin-like medications
  • At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds
  • No concurrent GM-CSF other than study drug
  • No concurrent G-CSF
  • No concurrent radiotherapy
  • No concurrent glucocorticosteroids
  • No concurrent parenteral antibiotics
  • No concurrent immunosuppressive agents
  • No concurrent drugs that cause bleeding tendencies
  • No other concurrent biologic therapy, immunotherapy, radiotherapy, or chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514215

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
Contact: Peter J. Littrup     313-576-8758        
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Peter J. Littrup, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute ( Peter J. Littrup )
Study ID Numbers: CDR0000559667, WSU-C-2795, WSU-HIC-050304M1(R)F
Study First Received: August 8, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00514215     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
lung metastases
stage I non-small cell lung cancer
stage II non-small cell lung cancer
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
recurrent renal cell cancer
stage IV renal cell cancer
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Thoracic Neoplasms
Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Urologic Neoplasms
Recurrence
Carcinoma
Renal Cancer
Respiratory Tract Diseases
Urologic Diseases
Lung Neoplasms
Kidney Neoplasms
Lung Diseases
Neoplasm Metastasis
Carcinoma, Renal Cell
Non-small Cell Lung Cancer
Kidney Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Urologic Diseases
Kidney Neoplasms
Lung Neoplasms
Lung Diseases
Carcinoma, Renal Cell
Neoplasm Metastasis
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 04, 2009