Lymphoma Clinical Trial
Official title:
Phase I Trial of High Dose Chemotherapy Using Amifostine for In-Vivo Protection of GM-CSF Primed Progenitor Cells
RATIONALE: Drugs used in chemotherapy use different ways to stop tumors from dividing so
they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal
cells from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of amifostine plus combination
chemotherapy in treating patients with advanced cancer.
OBJECTIVES: I. Determine the effects of priming on the granulocyte and thrombocyte nadirs
produced by high dose cyclophosphamide and carboplatin in patients with advanced
malignancies. II. Determine the effects of amifostine on the granulocyte and thrombocyte
nadirs produced by this same regimen when administered with sargramostim primed progenitor
cells. III. Determine the maximum tolerated dose of cyclophosphamide and carboplatin that
can be administered with sargramostim primed progenitor cells.
OUTLINE: This is a dose escalation study. Patients receive intravenous amifostine over 10
minutes on day 0, followed by intravenous cyclophosphamide and carboplatin consecutively
over 5-15 minutes. Sargramostim is administered subcutaneously on days -7 to -2 and again
beginning on day 1 until absolute neutrophil count is appropriate. Course is repeated every
28 days until disease progression or unacceptable toxic effects are observed. Nonresponding
patients discontinue treatment after 2 courses. Patients are treated for a maximum of 6
courses. Groups of 3-6 patients receive escalating doses of cyclophosphamide and carboplatin
until the maximum tolerated dose (MTD) is determined. If dose limiting toxicity (DLT) occurs
in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower
dose is declared the MTD.
PROJECTED ACCRUAL: Approximately 24-30 patients will be accrued for this study within 1
year.
;
Primary Purpose: Supportive Care
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