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Melphalan

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Amifostine

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Patients with solid tumor or brain tumor in the 1-18 years old stratum.

Patients with solid tumor or brain tumor in the 19-45 years old stratum.

Patients receive amifostine intravenous (IV) over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1.

Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined.

amifostine trihydrate

Patients receive oral busulfan every 6 hours on days -8 to -6.

busulfan

All patients receive filgrastim (G-CSF) IV for 1 week.

filgrastim

melphalan intravenous (IV) over 30 minutes on days -5 and -4

melphalan

thiotepa intravenous (IV) over 2 hours on days -3 and -2.

thiotepa

peripheral blood stem cell transplantation (PBSC)

John P. Perentesis, MD

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. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.

OBJECTIVES:

* Determine the dose-limiting toxicity of amifostine chemoprotection with peripheral blood stem cell transplantation plus chemotherapy in patients with high-risk or relapsed solid tumors or brain tumors.
* Determine response or time to disease progression in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of amifostine. Patients are stratified according to age (1 to 18 vs 19 to 45 years).

All patients receive filgrastim (G-CSF) IV for 1 week. On day 6 of G-CSF administration, patients undergo peripheral blood stem cell (PBSC) harvest followed by chemotherapy.

Patients receive oral busulfan every 6 hours on days -8 to -6 followed by melphalan IV over 30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2. Patients receive amifostine IV over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1. PBSC are reinfused on day 0.

Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed on day 50; at 3, 6, and 9 months; and at 1, 2, and 3 years post PBSC transplantation.

PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors

A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors

Masonic Cancer Center, University of Minnesota

John Perentesis, MD

Blood and Lymph Conditions

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Antifungal Agents

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Antitubercular Agents

Adenosine

This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.

2 mg/kg IV over 2 hours every 12 hours starting at 0700 on days -1, 0, and +1 (total of six doses).

cyclosporine

15 mg/kg orally twice a day starting day 0 until day +27 then stopped without tapering in the absence of aGVHD then tapered over two months in the absence of aGVHD. Doses will be rounded to the nearest 250 mg.

mycophenolate mofetil

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors	NCT00003926	Brain and Centr... Childhood Germ ... Chordoma Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma	amifostine trih... busulfan filgrastim melphalan thiotepa peripheral bloo...	1 Year - 45 Years	Masonic Cancer Center, University of Minnesota
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors	NCT00003926	Brain and Centr... Childhood Germ ... Chordoma Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma	amifostine trih... busulfan filgrastim melphalan thiotepa peripheral bloo...	1 Year - 45 Years	Masonic Cancer Center, University of Minnesota
Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer	NCT00816413	Chronic Myelopr... Leukemia Lymphoma Myelodysplastic... Nonmalignant Ne...	cyclosporine mycophenolate m... pentostatin cytogenetic ana... fluorescence in... protein analysi... flow cytometry immunoenzyme te... laboratory biom... reduced-intensi... nonmyeloablativ... peripheral bloo... total-body irra...	19 Years - 75 Years	University of Nebraska

Spots Global Cancer Trial Database for peripheral blood stem cell transplantation (pbsc)