Status:
COMPLETED
Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Sirius Medicine
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
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 pat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00091052
Start Date
July 1 2004
End Date
June 1 2006
Last Update
March 26 2013
Active Locations (1)
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1
Sirius Medicine, LLC
Loveland, Colorado, United States, 80538