Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors
NCT ID: NCT00003926
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
13 participants
INTERVENTIONAL
1998-11-30
2003-08-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Solid/brain tumor patients (1-18 years)
Patients with solid tumor or brain tumor in the 1-18 years old stratum.
amifostine trihydrate
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.
busulfan
Patients receive oral busulfan every 6 hours on days -8 to -6.
filgrastim
All patients receive filgrastim (G-CSF) IV for 1 week.
melphalan
melphalan intravenous (IV) over 30 minutes on days -5 and -4
thiotepa
thiotepa intravenous (IV) over 2 hours on days -3 and -2.
peripheral blood stem cell transplantation (PBSC)
PBSC are reinfused on day 0
Solid/brain tumor patients (19-45 years)
Patients with solid tumor or brain tumor in the 19-45 years old stratum.
amifostine trihydrate
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.
busulfan
Patients receive oral busulfan every 6 hours on days -8 to -6.
filgrastim
All patients receive filgrastim (G-CSF) IV for 1 week.
melphalan
melphalan intravenous (IV) over 30 minutes on days -5 and -4
thiotepa
thiotepa intravenous (IV) over 2 hours on days -3 and -2.
peripheral blood stem cell transplantation (PBSC)
PBSC are reinfused on day 0
Interventions
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amifostine trihydrate
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.
busulfan
Patients receive oral busulfan every 6 hours on days -8 to -6.
filgrastim
All patients receive filgrastim (G-CSF) IV for 1 week.
melphalan
melphalan intravenous (IV) over 30 minutes on days -5 and -4
thiotepa
thiotepa intravenous (IV) over 2 hours on days -3 and -2.
peripheral blood stem cell transplantation (PBSC)
PBSC are reinfused on day 0
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic or relapsed Ewing's sarcoma
* Metastatic or relapsed rhabdomyosarcoma
* Refractory Wilms' tumor
* Diffuse anaplastic Wilms' tumor
* Stage III or IV neuroblastoma
* Recurrent retinoblastoma
* Metastatic or relapsed germ cell tumors
* Metastatic or relapsed other soft tissue sarcomas
* Small cell ovarian sarcoma
* Metastatic or relapsed primitive neuroectodermal tumors of the bone
* Recurrent brain tumors
* Desmoplastic small round cell tumors
* Recurrent or metastatic chordomas
* Metastatic or relapsed hepatoblastoma
* Patients receive peripheral blood stem cell transplantation only if in complete remission or in very good partial remission with no disease progression
* Must have radiologic, nuclear image, or histologic verification of relapse
* Age 1 to 45
* Performance status:Karnofsky 70-100%
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin count at least 10 g/dL
* Bilirubin less than 2 times upper limit of normal (ULN)
* SGOT or SGPT less than 2.5 times ULN
* Creatinine less than 2 times ULN
* Creatinine clearance greater than 70 mL/min
* Cardiac shortening fraction greater than 30%
* Cardiac ejection fraction greater than 45%
* At least 1 week since prior hematopoietic growth factor and recovered
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* Recovered from any prior therapy
Exclusion Criteria
* Less than 4 months
* Uncontrolled bleeding
* Congestive heart failure
* Uncontrolled hypertension
* Asthma
* Pregnant or nursing
* Uncontrolled metabolic disease
* Active severe infection
* Allergy to aminothiol compounds
* Prior bone marrow transplantation
* Other concurrent investigational agents
1 Year
45 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Masonic Cancer Center, University of Minnesota
Principal Investigators
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John P. Perentesis, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
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University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-MT-9713
Identifier Type: OTHER
Identifier Source: secondary_id
UMN-9712M00074
Identifier Type: OTHER
Identifier Source: secondary_id
1997LS053
Identifier Type: -
Identifier Source: org_study_id