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

This study is no longer recruiting patients.

Sponsored by: University of Minnesota Cancer Center
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
childhood soft tissue sarcoma
childhood liver cancer
adult soft tissue sarcoma
Bone Cancer
ovarian sarcoma
Testicular Cancer
Brain Tumor
Eye Cancer
kidney tumor
 Procedure: supportive care
 Procedure: chemotherapy
 Procedure: biological response modifier therapy
 Behavior: supportive care/therapy
 Procedure: colony-stimulating factor therapy
 Procedure: peripheral blood stem cell transplantation
 Drug: chemoprotection
 Procedure: cytokine therapy
 Drug: bone marrow ablation with stem cell support
 Drug: amifostine
 Drug: busulfan
 Drug: filgrastim
 Drug: melphalan
 Drug: thiotepa
Phase I

MedlinePlus related topics:  Bone Cancer;   Brain Cancer;   Eye Cancer;   Kidney Cancer;   Liver Cancer;   Soft Tissue Sarcoma;   Testicular Cancer

Study Type: Interventional
Study Design: Educational/Counseling/Training

Official Title: Phase I Study of Amifostine Chemoprotection With Peripheral Blood Stem Cell Transplantation in Patients With High-Risk or Relapsed Solid Tumors or Brain Tumors

Further Study Details: 

Study start: November 1998

OBJECTIVES: I. 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. II. Determine response or time to disease progression in patients treated with this regimen.

PROTOCOL 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   -   45 Years

Criteria

PROTOCOL 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:

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

Location Information


Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States

Study chairs or principal investigators

John Peter Perentesis,  Study Chair,  University of Minnesota Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067114; UMN-MT-9713; NCI-V99-1553; ALZA-UMN-MT-9713; UMN-9712M00074
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003926
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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