Radiation Therapy and Sargramostim in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: sargramostim
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: sargramostim|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific