Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Chordoma; Drug/Agent Toxicity by Tissue/Organ; Extragonadal Germ Cell Tumor; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Retinoblastoma; Sarcoma; Testicular Germ Cell Tumor
Intervention: amifostine trihydrate (Drug); busulfan (Drug); filgrastim (Drug); melphalan (Drug); thiotepa (Drug); peripheral blood stem cell transplantation (Procedure)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Masonic Cancer Center at University of Minnesota Official(s) and/or principal investigator(s):
John P. Perentesis, MD, Study Chair, Affiliation: Masonic Cancer Center at University of Minnesota
Summary
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.
Clinical Details
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 design: Supportive Care
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.
Eligibility
Minimum age: 1 Year.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- 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
- No osteogenic sarcoma
- 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
PATIENT CHARACTERISTICS:
Age:
- 1 to 45
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 4 months
Hematopoietic:
- No uncontrolled bleeding
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin count at least 10 g/dL
Hepatic:
- Bilirubin less than 2 times upper limit of normal (ULN)
- SGOT or SGPT less than 2. 5 times ULN
Renal:
- Creatinine less than 2 times ULN
- Creatinine clearance greater than 70 mL/min
Cardiovascular:
- Cardiac shortening fraction greater than 30%
- Cardiac ejection fraction greater than 45%
- No congestive heart failure
- No uncontrolled hypertension
Pulmonary:
- No asthma
Other:
- Not pregnant or nursing
- No uncontrolled metabolic disease
- No active severe infection
- No allergy to aminothiol compounds
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 week since prior hematopoietic growth factor and recovered
- No prior bone marrow transplantation
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- Recovered from any prior therapy
- No other concurrent investigational agents
Locations and Contacts
University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: November 1998
Last updated: June 17, 2008
|
