Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors

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Brief Title

Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors

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

Brief 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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Brain and Central Nervous System Tumors

Intervention

amifostine trihydrate

Study Arms / Comparison Groups

 Solid/brain tumor patients (1-18 years)
Description:  Patients with solid tumor or brain tumor in the 1-18 years old stratum.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

13

Start Date

November 1998

Completion Date

August 2003

Primary Completion Date

August 2002

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  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

          -  Age 1 to 45

          -  Performance status:Karnofsky 70-100%

          -  Absolute neutrophil count greater than 1,000/mm^3

          -  Platelet count greater than 100,000/mm^3

          -  Hemoglobin count at least 10 g/dL

          -  Bilirubin less than 2 times upper limit of normal (ULN)

          -  SGOT or SGPT less than 2.5 times ULN

          -  Creatinine less than 2 times ULN

          -  Creatinine clearance greater than 70 mL/min

          -  Cardiac shortening fraction greater than 30%

          -  Cardiac ejection fraction greater than 45%

          -  At least 1 week since prior hematopoietic growth factor and recovered

          -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

          -  Recovered from any prior therapy

        Exclusion Criteria:

          -  Osteogenic sarcoma

          -  Less than 4 months

          -  Uncontrolled bleeding

          -  Congestive heart failure

          -  Uncontrolled hypertension

          -  Asthma

          -  Pregnant or nursing

          -  Uncontrolled metabolic disease

          -  Active severe infection

          -  Allergy to aminothiol compounds

          -  Prior bone marrow transplantation

          -  Other concurrent investigational agents
      

Gender

All

Ages

1 Year - 45 Years

Accepts Healthy Volunteers

No

Contacts

John P. Perentesis, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00003926

Organization ID

1997LS053

Secondary IDs

UMN-MT-9713


Study Sponsor

Masonic Cancer Center, University of Minnesota


Study Sponsor

John P. Perentesis, MD, Study Chair, Masonic Cancer Center, University of Minnesota


Verification Date

November 2017