Metastatic Cancer, Sarcoma
Conditions
Keywords
metastatic osteosarcoma, recurrent osteosarcoma, lung metastases
Brief summary
RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the growth of tumor cells and shrink the tumor so that it can be removed during surgery. Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective treatment for osteosarcoma that has spread to the lung. PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread to the lung.
Detailed description
OBJECTIVES: Primary * Assess the histological findings from patients with first pulmonary recurrence of osteosarcoma who undergo resection of pulmonary metastases after treatment with 2 courses of aerosolized sargramostim (GM-CSF). * Determine the event-free survival of patients treated with this drug. * Determine whether the maximum tolerated dose in the trial of inhaled GM-CSF in adult patients with melanoma is tolerable in pediatric patients. Secondary * Determine the effect of specific thoracic surgical management on outcome in patients treated with this drug. OUTLINE: This is a multicenter, dose escalation study. Patients are assigned to 1 of 2 groups according to the extent of pulmonary recurrence (unilateral or bilateral). * Group I (unilateral recurrence): * Initial inhalation therapy: Patients receive inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. * Thoracotomy: Patients undergo thoracotomy on day 22. * Post-thoracotomy inhalation therapy: Beginning on day 29, or as soon as possible thereafter, patients resume inhalation therapy as above for up to 12 additional courses. * Group II (bilateral recurrence): Patients may be enrolled on study either before or after the first thoracotomy. * First thoracotomy: Patients undergo unilateral thoracotomy. * Initial inhalation therapy: Patients receive inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. * Contralateral thoracotomy: Patients undergo contralateral thoracotomy on day 22. * Post-thoracotomy inhalation therapy: Beginning on day 29, or as soon as possible, patients resume inhalation therapy as above for up to 12 additional courses. Treatment in both groups continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1.6-2 years.
Interventions
BIOLOGICALsargramostim
given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
PROCEDUREconventional surgery
thoracotomy
Sponsors
National Cancer Institute (NCI)
Children's Oncology Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 39 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed osteosarcoma at primary diagnosis * Lesions detected in at least 1 lung that are consistent with metastatic disease and approachable with thoracotomy * No prior recurrence of osteosarcoma * No other sites of metastases * Resectable pulmonary nodule(s), defined as nodule(s) that are removable without performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels) * Prior thoracotomy allowed in patients with imaging consistent with metastatic involvement in both lungs provided the lung on which the thoracotomy was performed is disease-free * No pleural effusion or pleural based nodules PATIENT CHARACTERISTICS: Age * 39 and under Performance status * Karnofsky 50-100% (patients over 16 years of age) * Lansky 50-100% (patients 16 years of age and under) Life expectancy * At least 8 weeks Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Pulmonary * No evidence of dyspnea at rest * No exercise intolerance * Pulse oximetry at least 94% * Baseline Forced expiratory volume in 1 second (FEV\_1) at least 80% of predicted * No history of asthma * No history of reactive airway disease * No history of bronchospasm Other * Willing and able to perform inhalation therapy * No medical contraindication to surgical excision * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent immunotherapy * No other concurrent immunomodulating agents Chemotherapy * No concurrent anticancer chemotherapy Endocrine therapy * No concurrent steroids by any route Radiotherapy * Not specified Surgery * See Disease Characteristics * No concurrent thoracoscopy or video-assisted thoracic surgery Other * No more than 1 prior treatment regimen for osteosarcoma * No concurrent participation in another COG therapeutic study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Status of FAS Ligand in Pre-chemotherapy Sample | 29 days after start of protocol therapy | FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories. |
| Presence of FAS in Pre-chemotherapy Sample | 29 days after start of protocol therapy | FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories. |
| FAS Ligand in Post Chemotherapy Sample | 29 days after start of protocol therapy | FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories. |
| FAS Status in Post Chemotherapy Sample | 29 days after start of protocol therapy | FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories. |
| CD1a Status in Pre Chemotherapy Sample | 29 days after start of protocol therapy | CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity. |
| CD1a Status in Post Chemotherapy Sample | 29 days after start of protocol therapy | CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity. |
| S100 Status in Pre Chemotherapy Sample | 29 days after start of protocol therapy | The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation. |
| S100 Status in Post Chemotherapy Sample | 29 days after start of protocol therapy | The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation. |
| Clusterin Status in Pre Chemotherapy Sample | 29 days after start of protocol therapy | The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders. |
| Clusterin Status in Post Chemotherapy Sample | 29 days after start of protocol therapy | — |
| Event Free Survival (EFS) | Time of enrollment to Event or 5 years from enrollment, whichever occurs first | EFS defined as the time from enrollment on the study until disease progression, occurrence of a second malignant neoplasm (SMN), death or last contact, whichever comes first. Disease progression, occurrence of a SMN or death will be considered an analytic even. In all other cases, the patient will be considered censored at last contact. |
| Feasibility Success | Enrollment through 21 days of protocol therapy | Feasibility success defined as received 21 days of protocol therapy, did not experience grade III or grade IV toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 3 and rendered surgically free of disease in the lungs. |
Countries
Australia, Canada, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy | 31 |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.
conventional surgery: thoracotomy | 18 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Ineligible | 4 | 2 |
| Overall Study | Lack of Efficacy | 15 | 12 |
| Overall Study | No viable tumor after 1 cycle of therapy | 2 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy |
|---|---|---|---|
| Age, Categorical <=18 years | 39 Participants | 25 Participants | 14 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 6 Participants | 4 Participants |
| Age, Continuous | 16 years | 16 years | 17 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 29 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 7 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 38 Participants | 22 Participants | 16 Participants |
| Region of Enrollment Canada | 1 participants | 1 participants | 0 participants |
| Region of Enrollment United States | 48 participants | 30 participants | 18 participants |
| Sex: Female, Male Female | 20 Participants | 15 Participants | 5 Participants |
| Sex: Female, Male Male | 29 Participants | 16 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 27 | 4 / 16 |
| serious Total, serious adverse events | 4 / 27 | 0 / 16 |
Outcome results
Primary
CD1a Status in Post Chemotherapy Sample
CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
Time frame: 29 days after start of protocol therapy
Population: 20 patients were evaluated for this outcome measure from the unilateral group and 7 patients were evaluated from the bilateral group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | CD1a Status in Post Chemotherapy Sample | Focally Positive | 12 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | CD1a Status in Post Chemotherapy Sample | Negative | 8 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | CD1a Status in Post Chemotherapy Sample | Negative | 5 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | CD1a Status in Post Chemotherapy Sample | Focally Positive | 2 participants |
Primary
CD1a Status in Pre Chemotherapy Sample
CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.
Time frame: 29 days after start of protocol therapy
Population: Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | CD1a Status in Pre Chemotherapy Sample | Negative | 5 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | CD1a Status in Pre Chemotherapy Sample | Focally Positive | 2 participants |
Primary
Clusterin Status in Post Chemotherapy Sample
Time frame: 29 days after start of protocol therapy
Population: This outcome measure was evaluated in 30 patients, 20 patients in the unilateral recurrence group and 10 patients in bilateral recurrence group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | Clusterin Status in Post Chemotherapy Sample | Focally Positive | 3 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | Clusterin Status in Post Chemotherapy Sample | Negative | 17 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Clusterin Status in Post Chemotherapy Sample | Negative | 7 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Clusterin Status in Post Chemotherapy Sample | Focally Positive | 3 participants |
Primary
Clusterin Status in Pre Chemotherapy Sample
The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders.
Time frame: 29 days after start of protocol therapy
Population: Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were measured from the bilateral recurrence group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Clusterin Status in Pre Chemotherapy Sample | Negative | 5 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Clusterin Status in Pre Chemotherapy Sample | Focally Positive | 2 participants |
Primary
Event Free Survival (EFS)
EFS defined as the time from enrollment on the study until disease progression, occurrence of a second malignant neoplasm (SMN), death or last contact, whichever comes first. Disease progression, occurrence of a SMN or death will be considered an analytic even. In all other cases, the patient will be considered censored at last contact.
Time frame: Time of enrollment to Event or 5 years from enrollment, whichever occurs first
Population: There were 4 ineligible unilateral patients and 2 ineligible bilateral patients not included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | Event Free Survival (EFS) | .57 years |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Event Free Survival (EFS) | .33 years |
Primary
FAS Ligand in Post Chemotherapy Sample
FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.
Time frame: 29 days after start of protocol therapy
Population: 22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | FAS Ligand in Post Chemotherapy Sample | IHC Category 0 | 16 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | FAS Ligand in Post Chemotherapy Sample | IHC Category 1 | 4 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | FAS Ligand in Post Chemotherapy Sample | IHC Category 2 | 1 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | FAS Ligand in Post Chemotherapy Sample | IHC Category 3 | 1 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | FAS Ligand in Post Chemotherapy Sample | IHC Category 3 | 2 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | FAS Ligand in Post Chemotherapy Sample | IHC Category 0 | 7 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | FAS Ligand in Post Chemotherapy Sample | IHC Category 2 | 2 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | FAS Ligand in Post Chemotherapy Sample | IHC Category 1 | 2 participants |
Primary
FAS Status in Post Chemotherapy Sample
FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
Time frame: 29 days after start of protocol therapy
Population: 22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | FAS Status in Post Chemotherapy Sample | IHC Category 0 | 14 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | FAS Status in Post Chemotherapy Sample | IHC Category 1 | 4 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | FAS Status in Post Chemotherapy Sample | IHC Category 2 | 1 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | FAS Status in Post Chemotherapy Sample | IHC Category 3 | 3 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | FAS Status in Post Chemotherapy Sample | IHC Category 3 | 4 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | FAS Status in Post Chemotherapy Sample | IHC Category 0 | 5 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | FAS Status in Post Chemotherapy Sample | IHC Category 2 | 0 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | FAS Status in Post Chemotherapy Sample | IHC Category 1 | 4 participants |
Primary
Feasibility Success
Feasibility success defined as received 21 days of protocol therapy, did not experience grade III or grade IV toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 3 and rendered surgically free of disease in the lungs.
Time frame: Enrollment through 21 days of protocol therapy
Population: This outcome measure was calculated for eligible patients only. This yields 27 patients for assessment of this measure in Group 1 and 16 patients for assessment of this measure in Group 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | Feasibility Success | Yes | 24 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | Feasibility Success | No | 3 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Feasibility Success | Yes | 16 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Feasibility Success | No | 0 participants |
Primary
Presence of FAS in Pre-chemotherapy Sample
FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.
Time frame: 29 days after start of protocol therapy
Population: Patients who were enrolled in Group 1 (unilateral recurrence) do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Presence of FAS in Pre-chemotherapy Sample | IHC Category 0 | 5 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Presence of FAS in Pre-chemotherapy Sample | IHC Category 1 | 5 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Presence of FAS in Pre-chemotherapy Sample | IHC Category 2 | 2 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Presence of FAS in Pre-chemotherapy Sample | IHC Category 3 | 2 participants |
Primary
S100 Status in Post Chemotherapy Sample
The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation.
Time frame: 29 days after start of protocol therapy
Population: 20 patients from the unilateral recurrence group and 10 patients from the bilateral recurrence group were evaluated for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | S100 Status in Post Chemotherapy Sample | Negative | 17 participants |
| Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy | S100 Status in Post Chemotherapy Sample | Focally Positive | 3 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | S100 Status in Post Chemotherapy Sample | Negative | 9 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | S100 Status in Post Chemotherapy Sample | Focally Positive | 1 participants |
Primary
S100 Status in Pre Chemotherapy Sample
The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation.
Time frame: 29 days after start of protocol therapy
Population: Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | S100 Status in Pre Chemotherapy Sample | Negative | 4 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | S100 Status in Pre Chemotherapy Sample | Focally Positive | 3 participants |
Primary
Status of FAS Ligand in Pre-chemotherapy Sample
FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.
Time frame: 29 days after start of protocol therapy
Population: Patients who were enrolled in the unilateral recurrence group do not contribute to the assessment of any Pre Chemotherapy analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 14 patients were evaluated for this primary outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Status of FAS Ligand in Pre-chemotherapy Sample | IHC Category 0 | 7 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Status of FAS Ligand in Pre-chemotherapy Sample | IHC Category 1 | 5 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Status of FAS Ligand in Pre-chemotherapy Sample | IHC Category 2 | 1 participants |
| Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy | Status of FAS Ligand in Pre-chemotherapy Sample | IHC Category 3 | 1 participants |