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| Sponsor: | Masonic Cancer Center, University of Minnesota |
|---|---|
| Information provided by: | Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00003926 |
Purpose
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 | Intervention | 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 I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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 |
| Enrollment: | 13 |
| Study Start Date: | November 1998 |
| Study Completion Date: | August 2003 |
| Primary Completion Date: | August 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Solid/brain tumor patients (1-18 years)
Patients with solid tumor or brain tumor in the 1-18 years old stratum.
|
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
|
|
Experimental: Solid/brain tumor patients (19-45 years)
Patients with solid tumor or brain tumor in the 19-45 years old stratum.
|
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
|
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 1 Year to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | John Perentesis, MD, Masonic Cancer Center, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00003926 History of Changes |
| Other Study ID Numbers: | 1997LS053, UMN-MT-9713, UMN-9712M00074 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 20, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Brain Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Chordoma Liver Neoplasms Nervous System Neoplasms Neuroblastoma Ovarian Neoplasms Retinoblastoma Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Sarcoma Neoplasms by Site Neoplasms Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Digestive System Neoplasms Digestive System Diseases Liver Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive |
