Clinical trial · Interventional
Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
Percutaneous Cryotherapy and Aerosolized GM-CSF for Pulmonary Metastases and Primary Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| cryosurgery | Procedure | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sargramostim, Flow Cytometry, Biopsy. Cryosurgery
- description
- Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 \& 32 Immunoenzyme technique-Days 1 \& 32 CT guided biopsy-Days 1 \& 32 Cryosurgery-Days 1 and 32
- interventionNames
- Biological: sargramostim
- Other: flow cytometry
- Other: immunoenzyme technique
- Procedure: biopsy
- Procedure: cryosurgery
Primary outcomes (1)
- measure
- Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry
- timeFrame
- Days 1 & 32
- description
- CT-guided biopsy \& Peritumoral GM-CSF. a CR was defined as involution of the prior tumor and/or ablation site to only a thin, non-enhancing scar within the pulmonary parenchyma on enhanced chest CT. A PR was defined as incomplete resolution of an otherwise thoroughly hypovascular resolving ablation zone which had reached a diameter smaller than the original tumor size. Stable disease (SD) reflects no significant change in size of ablation site and/or overall tumor burden, while the standard definition for progressive disease (PD) remains as evidence of neTw or growing tumors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 chemotherapyReferences
Publications (0)
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