Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
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. 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.
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.
Interventions
BIOLOGICALsargramostim
RADIATIONradiation therapy
Sponsors
Sirius Medicine
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity as measured by the Southwest Oncology Group Performance Status and Toxicity Criteria on day 1 and in weeks 4, 12, and 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed