Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
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
Safety Issue:
Yes
Principal Investigator
Michael D. Weil, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sirius Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000383147
NCT ID:
NCT00091052
Start Date:
July 2004
Completion Date:
June 2006
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Sirius Medicine, LLC | Loveland, Colorado 80538 |
