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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.