CompletedPhase 2NCT00514215

Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer

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.

Checked against the public recordLast updated Mar 5, 2020 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorBarbara Ann Karmanos Cancer Institute
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Barbara Ann Karmanos Cancer Institute
Interventions being studied
Biological: sargramostim; Other: flow cytometry; Other: immunoenzyme technique; Procedure: biopsy; Procedure: cryosurgery
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Barbara Ann Karmanos Cancer InstituteDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 5, 2020. Always confirm current availability with the study team.

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