Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066365
Status:
COMPLETED
Last Update Posted:
2015-03-30
First Post:
2003-08-06
Brief Title:
Inhaled Sargramostim in Treating Patients With First Pulmonary Lung Recurrence of Osteosarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of Aerosolized GM-CSF NSC 613795 IND 11042 in Patients With First Pulmonary Recurrence of Osteosarcoma
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 16-2 years
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 16-2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | NCI | httpsreporternihgovquickSearchU10CA098543 |
| CDR0000315540 | OTHER | None | None |
| COG-AOST0221 | OTHER | None | None |
| NCI-2012-02543 | OTHER | None | None |