Trial · NCT00514215
Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
NCT00514215, Phase 2, Completed, Barbara Ann Karmanos Cancer Institute; results first posted 2015-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer. Trials, record NCT00514215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00514215
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
- NCT number
- NCT00514215
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Conditions
- Kidney Cancer, Lung Cancer, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- sargramostim, flow cytometry, immunoenzyme technique, biopsy, cryosurgery
- First posted
- 2007-08-09
- Last updated
- 2020-03-05
- Results first posted
- 2015-02-23
- Limitations and caveats
- Small sample size.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry | Days 1 & 32 | 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. |
| Secondary | Clinical Response as Measured by CT Criteria | Days 1 & 32 | CT-guided biopsy. 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. |
| Secondary | Toxicity of Grade 1 or Higher | Days 11, 32, 43, & 63 | Number of Participants with Toxicity of Grade 1 or Higher as defined by CTCAE v2 |
| Secondary | Immune Function and Cancer-specific Response | Days 1 & 63 | Number of Participants with CT-guided biopsy \& Peritumoral GM-CSF. The number of IFNγ secreting T-cells was measured by a direct EliSpots at 10:1 E:T ratio to define the kinetics of the CTL responses from pre-CI to day 63 post CI. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry | Days 1 & 32 | Patients who had metastatic Renal Cell carcinoma | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Response as Measured by CT Criteria | Days 1 & 32 | only those with metastatic Renal Cell carcinoma | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Toxicity of Grade 1 or Higher | Days 11, 32, 43, & 63 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Immune Function and Cancer-specific Response | Days 1 & 63 | only those with metastatic Renal Cell carcinoma | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Complete Response | 1 | Participants | |
| Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Partial Response | 3 | Participants | |
| Immunologic Response as Measured by ELISPOT Assay and Flow Cytometry | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Progressive Disease | 2 | Participants | |
| Clinical Response as Measured by CT Criteria | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Complete Response | 1 | Participants | |
| Clinical Response as Measured by CT Criteria | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Partial Response | 3 | Participants | |
| Clinical Response as Measured by CT Criteria | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Progressive Disease | 2 | Participants | |
| Toxicity of Grade 1 or Higher | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Alergic Reaction | 1 | Participants | |
| Toxicity of Grade 1 or Higher | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Allergic rhinitis | 2 | Participants | |
| Toxicity of Grade 1 or Higher | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Anemia | 1 | Participants | |
| Toxicity of Grade 1 or Higher | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | Anorexia | 1 | Participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 8 | |
| Overall Study | COMPLETED | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 8 | |
| Overall Study | NOT COMPLETED | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 0 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic Reaction | Immune system disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 1 | 8 | 1 |
| other | Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 2 | 8 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 1 | 8 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 1 | 8 | 1 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 1 | 8 | 1 |
| other | Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 1 | 8 | 1 |
| other | Chest Pain (noncardiac, nonpleuritic) | General disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 1 | 8 | 1 |
| other | Chest Wall Pain | Musculoskeletal and connective tissue disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 6 | 8 | 12 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 7 | 8 | 12 |
| other | Decreased Platelets ( thrombocytopenia) | Blood and lymphatic system disorders | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 1 | 8 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | ||
| Total, other adverse events | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 7 | 8 |
| Total, serious adverse events | Sargramostim, Flow Cytometry, Biopsy. Cryosurgery | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00514215
GET https://conductscience.org/api/trials/v1/NCT00514215/results?page=2