Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00091052|
Recruitment Status : Completed
First Posted : September 8, 2004
Last Update Posted : March 26, 2013
RATIONALE: Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with sargramostim may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects of giving radiation therapy together with sargramostim and to see how well it works in treating patients with advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: sargramostim Radiation: radiation therapy||Phase 1 Phase 2|
- Determine the safety of contrast-enhanced high-dose radiotherapy administered with sargramostim (GM-CSF) in patients with advanced solid malignancies.
- Determine immune response in patients treated with this regimen.
- Determine tumor response in patients treated with this regimen.
OUTLINE: Patients are stratified according to prior therapy (biopsy or simple surgery vs radical surgery, chemotherapy, or radiotherapy).
Patients receive a contrast agent intratumorally followed by a single fraction of kilovoltage radiotherapy. Beginning 24 hours after radiotherapy, patients receive sargramostim (GM-CSF) intratumorally continuously for 1 week and then subcutaneously for 2 weeks. Patients with lung tumors receive GM-CSF by inhalation twice daily for 1 week and then every other week for a total of 3 weeks of drug treatment.
Treatment may repeat in several weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 47 patients (12 for phase I and 35 for phase II) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial|
|Study Start Date :||July 2004|
|Actual Study Completion Date :||June 2006|
- Toxicity as measured by the Southwest Oncology Group Performance Status and Toxicity Criteria on day 1 and in weeks 4, 12, and 20
- Immune and tumor response as measured by reverse transcriptase polymerase chain reaction (RT-PCR) and CT scan on day 1 and in weeks 2, 3, 4, 12, and 20 or weeks 4, 12, and 20
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091052
|United States, Colorado|
|Sirius Medicine, LLC|
|Loveland, Colorado, United States, 80538|
|Study Chair:||Michael D. Weil, MD||Sirius Medicine|