- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00091052
Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors
Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Colorado
-
Loveland, Colorado, United States, 80538
- Sirius Medicine, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed solid malignancy
- Advanced disease
Radiotherapy is appropriate treatment (i.e., radio-responsive)
- No tumors beyond the reach of kilovoltage beam (e.g., > 15 cm beneath the skin)
- At least 1 lesion accessible to needle localization and catheter placement
- May be refractory to prior chemotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- 0-4
Life expectancy
- At least 2 months
Hematopoietic
- Hemoglobin ≥ 10 g/dL (RBC transfusion allowed)
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3 (transfusion independent)
- No excessive leukemic blasts
- No bleeding diathesis
Hepatic
- PT and PTT ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT < 2 times ULN
- Alkaline phosphatase < 2 times ULN
Renal
- Creatinine < 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- No contraindication to MRI or CT scan
- No medical or psychiatric condition that would preclude giving informed consent
- Able to lie flat for 1 hour
- No known hypersensitivity to sargramostim (GM-CSF) or any of its components
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior biologic therapy allowed
- No concurrent biologic therapy
Chemotherapy
- See Disease Characteristics
- No concurrent chemotherapy
Endocrine therapy
- Concurrent hormonal therapy allowed
Radiotherapy
- Prior radiotherapy to planned treatment site allowed
- No other concurrent radiotherapy to planned treatment site
Surgery
- Prior surgery allowed
Other
- More than 14 days since prior radiosensitizers
- No other concurrent investigational therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Toxicity as measured by the Southwest Oncology Group Performance Status and Toxicity Criteria on day 1 and in weeks 4, 12, and 20
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Michael D. Weil, MD, Sirius Medicine
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000383147
- SIRIUS-1053285
- SIRIUS-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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