Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
Data Collection
Treatment Study
Summary
Study start date: July 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location