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Phase 2 N=8 Treatment

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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