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

NCT00514215 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000559667P30CA022453WSU-C-2795WSU-HIC-050304M1(R)F
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Cancer; Lung Cancer; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry

  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.

  Days 1 & 32

Secondary Outcomes (3)

• Clinical Response as Measured by CT Criteria

  Days 1 & 32

• Toxicity of Grade 1 or Higher

  Days 11, 32, 43, & 63

• Immune Function and Cancer-specific Response

  Days 1 & 63

Study Arms (1)

Sargramostim, Flow Cytometry, Biopsy. Cryosurgery

EXPERIMENTAL

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

Biological: sargramostim; Other: flow cytometry; Other: immunoenzyme technique; Procedure: biopsy; Procedure: cryosurgery

Interventions

sargramostim BIOLOGICAL

250 μg, inhaled, two times a day, on days 4-10 and days 36-42

Also known as: GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor), Leukine

Sargramostim, Flow Cytometry, Biopsy. Cryosurgery

flow cytometry OTHER

Days 1 \& 32

Sargramostim, Flow Cytometry, Biopsy. Cryosurgery

immunoenzyme technique OTHER

Days 1 \& 32

Sargramostim, Flow Cytometry, Biopsy. Cryosurgery

biopsy PROCEDURE

CT guided biopsy on days 1 \& 32

Sargramostim, Flow Cytometry, Biopsy. Cryosurgery

cryosurgery PROCEDURE

Days 1 and 32

Sargramostim, Flow Cytometry, Biopsy. Cryosurgery

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Kidney Neoplasms; Lung Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell

Interventions

sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor; Colony-Stimulating Factors; Flow Cytometry; Immunoenzyme Techniques; Biopsy; Cryosurgery

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Ablation Techniques

Limitations and Caveats

Small sample size.

Results Point of Contact

• Title: Peter Littrup, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

littrupp@karmanos.org

313-576-8758

Study Officials

• Peter J. Littrup, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: January 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 5, 2020
• Results First Posted: February 23, 2015

Record last verified: 2020-02

Locations

US (1)