Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Loveland, Colorado 80538


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00091052


Primary Contact:

Study Chair
Michael D. Weil, MD
Sirius Medicine


Backup Contact:

N/A


Location Contact:

Loveland, Colorado 80538
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.