Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors
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| ClinicalTrials.gov Identifier: NCT00003926 |
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Recruitment Status :
Terminated
(Withdrawn due to slow accrual)
First Posted : May 2, 2003
Last Update Posted : November 29, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Chordoma Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma | Drug: amifostine trihydrate Drug: busulfan Drug: filgrastim Drug: melphalan Drug: thiotepa Procedure: peripheral blood stem cell transplantation (PBSC) | Phase 1 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 13 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors |
| Study Start Date : | November 1998 |
| Actual Primary Completion Date : | August 2002 |
| Actual Study Completion Date : | August 2003 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Solid/brain tumor patients (1-18 years)
Patients with solid tumor or brain tumor in the 1-18 years old stratum.
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Drug: 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. Other Name: Ethyol Drug: busulfan Patients receive oral busulfan every 6 hours on days -8 to -6.
Other Name: Busulfex Drug: filgrastim All patients receive filgrastim (G-CSF) IV for 1 week.
Other Names:
Drug: melphalan melphalan intravenous (IV) over 30 minutes on days -5 and -4
Other Name: Alkeran Drug: thiotepa thiotepa intravenous (IV) over 2 hours on days -3 and -2.
Other Name: Thioplex Procedure: peripheral blood stem cell transplantation (PBSC) PBSC are reinfused on day 0
Other Name: bone marrow transplant |
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Experimental: Solid/brain tumor patients (19-45 years)
Patients with solid tumor or brain tumor in the 19-45 years old stratum.
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Drug: 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. Other Name: Ethyol Drug: busulfan Patients receive oral busulfan every 6 hours on days -8 to -6.
Other Name: Busulfex Drug: filgrastim All patients receive filgrastim (G-CSF) IV for 1 week.
Other Names:
Drug: melphalan melphalan intravenous (IV) over 30 minutes on days -5 and -4
Other Name: Alkeran Drug: thiotepa thiotepa intravenous (IV) over 2 hours on days -3 and -2.
Other Name: Thioplex Procedure: peripheral blood stem cell transplantation (PBSC) PBSC are reinfused on day 0
Other Name: bone marrow transplant |
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| Ages Eligible for Study: | 1 Year to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003926
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Study Chair: | John P. Perentesis, MD | Masonic Cancer Center, University of Minnesota |
| Responsible Party: | John Perentesis, MD, Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00003926 |
| Other Study ID Numbers: |
1997LS053 UMN-MT-9713 ( Other Identifier: Blood and Marrow Transplantation Program ) UMN-9712M00074 ( Other Identifier: IRB, University of Minnesota ) |
| First Posted: | May 2, 2003 Key Record Dates |
| Last Update Posted: | November 29, 2017 |
| Last Verified: | November 2017 |
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soft tissue sarcoma regional neuroblastoma disseminated neuroblastoma recurrent Wilms tumor recurrent retinoblastoma recurrent adult brain tumor adult rhabdomyosarcoma ovarian germ cell tumor chordoma ovarian sarcoma unresectable neuroblastoma desmoplastic small round cell tumor rhabdomyosarcoma Ewing sarcoma |
neuroectodermal tumor teratoma malignant testicular germ cell tumor malignant ovarian germ cell tumor extragonadal germ cell tumor malignant germ cell tumor hepatoblastoma liver cancer medulloblastoma cerebellar astrocytoma brain stem glioma glioma cerebral astrocytoma ependymoma |
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Neoplasms Sarcoma Liver Neoplasms Neuroblastoma Neoplasms, Germ Cell and Embryonal Nervous System Neoplasms Central Nervous System Neoplasms Retinoblastoma Chordoma Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Digestive System Neoplasms Digestive System Diseases Liver Diseases |
Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Diseases Retinal Neoplasms Eye Neoplasms Eye Diseases, Hereditary Eye Diseases Retinal Diseases Melphalan Busulfan Thiotepa |