Phase 2
N=8
Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
Kidney Cancer · Lung Cancer · Metastatic Cancer · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT00514215 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry — 1; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sargramostim (Biological); flow cytometry (Other); immunoenzyme technique (Other); biopsy (Procedure); cryosurgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry |
1; 3; 2 | — |
| SECONDARY Clinical Response as Measured by CT Criteria |
1; 3; 2 | — |
| SECONDARY Toxicity of Grade 1 or Higher |
1; 2; 1; 1; 1; 1 | — |
| SECONDARY Immune Function and Cancer-specific Response |
4; 4; 4 | — |
Summary
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00514215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.