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| Sponsor: | Masonic Cancer Center, University of Minnesota |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| 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 Cancer-related Problem/Condition Childhood Germ Cell Tumor Chordoma Extragonadal Germ Cell Tumor Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma Testicular Germ Cell Tumor |
Drug: amifostine trihydrate Drug: busulfan Drug: filgrastim Drug: melphalan Drug: thiotepa Procedure: peripheral blood stem cell transplantation |
Phase I |
| Study Type: | Interventional |
| Study Design: | 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | November 1998 |
| Study Completion Date: | March 2008 |
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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
| Study ID Numbers: | CDR0000067114, UMN-MT-9713, ALZA-UMN-MT-9713, UMN-9712M00074, NCI-V99-1553 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003926 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult soft tissue sarcoma regional neuroblastoma disseminated neuroblastoma recurrent Wilms tumor and other childhood kidney tumors recurrent retinoblastoma recurrent adult brain tumor adult rhabdomyosarcoma recurrent childhood soft tissue sarcoma stage IV ovarian germ cell tumor recurrent ovarian germ cell tumor chordoma ovarian sarcoma localized unresectable neuroblastoma childhood desmoplastic small round cell tumor previously treated childhood rhabdomyosarcoma |
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor metastatic childhood soft tissue sarcoma recurrent childhood rhabdomyosarcoma childhood teratoma childhood malignant testicular germ cell tumor childhood malignant ovarian germ cell tumor childhood extragonadal germ cell tumor recurrent childhood malignant germ cell tumor childhood hepatoblastoma recurrent childhood liver cancer stage IV childhood liver cancer recurrent childhood medulloblastoma recurrent childhood cerebellar astrocytoma recurrent childhood brain stem glioma |
|
Retinal Neoplasms Liver Diseases Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Retinoblastoma Neoplasms, Connective and Soft Tissue Neoplasms by Site Therapeutic Uses Kidney Diseases Nervous System Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Eye Neoplasms Nervous System Diseases Genital Neoplasms, Female Endocrine System Diseases Carcinoma Thiotepa Neuroectodermal Tumors Neoplasms Sarcoma Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial Melphalan Radiation-Protective Agents Immunologic Factors |
