A Phase 2 interventional study of aldesleukin and filgrastim in Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific and Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged Up to 56 Years. Per ClinicalTrials.gov, last updated 2010-05-14.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Biological therapies such as interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have solid tumors or lymphoma.
OBJECTIVES:
OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) alone on days 3-9 and GM-CSF and filgrastim (G-CSF) SC beginning on day 10 and continuing until leukapheresis is completed.
Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -8 to -6, melphalan IV on days -5 and -4, and thiotepa IV on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are treated ex vivo with interleukin-2 (IL-2) on day -1. Patients undergo IL-2-treated autologous PBSC transplantation on day 0.
Beginning 4 hours after PBSC transplantation, patients receive IL-2 IV continuously for 5 days. IL-2 therapy repeats every 7 days for 4 courses.
Patients are followed on days 60-80, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.
5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.
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Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
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The record gives a start of Aug 2001 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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