Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors

Basic Trial Information

Objectives

1. 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.
2. Determine response or time to disease progression in patients treated with this regimen.

Entry 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

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

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/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

A maximum of 60 patients (30 per stratum) will be accrued for this study within 3 years.

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.

Trial Contact Information

Trial Lead Organizations

Masonic Cancer Center at University of Minnesota

John Perentesis, MD, Protocol chair (Contact information may not be current)		Ph: 612-624-8484; 888-226-2376

Registry Information
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
Trial Start Date		1998-11-11
Registered in ClinicalTrials.gov		NCT00003926
Date Submitted to PDQ		1999-06-07
Information Last Verified		2002-11-22
NCI Grant/Contract Number		CA77598

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