- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003926
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
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including:
- 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:
- Osteogenic sarcoma
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Solid/brain tumor patients (1-18 years)
Patients with solid tumor or brain tumor in the 1-18 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.
Other Names:
Patients receive oral busulfan every 6 hours on days -8 to -6.
Other Names:
All patients receive filgrastim (G-CSF) IV for 1 week.
Other Names:
melphalan intravenous (IV) over 30 minutes on days -5 and -4
Other Names:
thiotepa intravenous (IV) over 2 hours on days -3 and -2.
Other Names:
PBSC are reinfused on day 0
Other Names:
|
Experimental: Solid/brain tumor patients (19-45 years)
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.
Other Names:
Patients receive oral busulfan every 6 hours on days -8 to -6.
Other Names:
All patients receive filgrastim (G-CSF) IV for 1 week.
Other Names:
melphalan intravenous (IV) over 30 minutes on days -5 and -4
Other Names:
thiotepa intravenous (IV) over 2 hours on days -3 and -2.
Other Names:
PBSC are reinfused on day 0
Other Names:
|
Collaborators and Investigators
Investigators
- Study Chair: John P. Perentesis, MD, Masonic Cancer Center, University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent adult brain tumor
- glioma
- Ewing sarcoma
- medulloblastoma
- rhabdomyosarcoma
- disseminated neuroblastoma
- adult rhabdomyosarcoma
- ovarian sarcoma
- regional neuroblastoma
- soft tissue sarcoma
- liver cancer
- extragonadal germ cell tumor
- ependymoma
- recurrent retinoblastoma
- hepatoblastoma
- recurrent Wilms tumor
- ovarian germ cell tumor
- chordoma
- unresectable neuroblastoma
- desmoplastic small round cell tumor
- neuroectodermal tumor
- teratoma
- malignant testicular germ cell tumor
- malignant ovarian germ cell tumor
- malignant germ cell tumor
- cerebellar astrocytoma
- brain stem glioma
- cerebral astrocytoma
Additional Relevant MeSH Terms
- Digestive System Diseases
- Nervous System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Digestive System Neoplasms
- Retinal Diseases
- Liver Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Nerve Tissue
- Eye Diseases, Hereditary
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Eye Neoplasms
- Retinal Neoplasms
- Neoplasms
- Sarcoma
- Neoplasms, Germ Cell and Embryonal
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Liver Neoplasms
- Chordoma
- Neuroblastoma
- Retinoblastoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Adjuvants, Immunologic
- Radiation-Protective Agents
- Lenograstim
- Melphalan
- Thiotepa
- Busulfan
- Amifostine
Other Study ID Numbers
- 1997LS053
- UMN-MT-9713 (Other Identifier: Blood and Marrow Transplantation Program)
- UMN-9712M00074 (Other Identifier: IRB, University of Minnesota)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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