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

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

amifostine trihydrate

busulfan

filgrastim

melphalan

thiotepa

peripheral blood stem cell transplantation (PBSC)

About this trial

This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring soft tissue sarcoma, regional neuroblastoma, disseminated neuroblastoma, recurrent Wilms tumor, recurrent retinoblastoma, recurrent adult brain tumor, adult rhabdomyosarcoma, ovarian germ cell tumor, chordoma, ovarian sarcoma, unresectable neuroblastoma, desmoplastic small round cell tumor, rhabdomyosarcoma, Ewing sarcoma, neuroectodermal tumor, teratoma, malignant testicular germ cell tumor, malignant ovarian germ cell tumor, extragonadal germ cell tumor, malignant germ cell tumor, hepatoblastoma, liver cancer, medulloblastoma, cerebellar astrocytoma, brain stem glioma, glioma, cerebral astrocytoma, ependymoma

Eligibility Criteria

1 Year - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Minnesota Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Solid/brain tumor patients (1-18 years)

Solid/brain tumor patients (19-45 years)

Arm Description

Patients with solid tumor or brain tumor in the 1-18 years old stratum.

Patients with solid tumor or brain tumor in the 19-45 years old stratum.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003926

First Posted

November 1, 1999

Last Updated

November 27, 2017

Sponsor

Masonic Cancer Center, University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT00003926

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

Withdrawn due to slow accrual

Study Start Date

November 1998 (undefined)

Primary Completion Date

August 2002 (Actual)

Study Completion Date

August 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Chordoma, Kidney Cancer, Liver Cancer, Neuroblastoma, Ovarian Cancer, Retinoblastoma, Sarcoma

Keywords

soft tissue sarcoma, regional neuroblastoma, disseminated neuroblastoma, recurrent Wilms tumor, recurrent retinoblastoma, recurrent adult brain tumor, adult rhabdomyosarcoma, ovarian germ cell tumor, chordoma, ovarian sarcoma, unresectable neuroblastoma, desmoplastic small round cell tumor, rhabdomyosarcoma, Ewing sarcoma, neuroectodermal tumor, teratoma, malignant testicular germ cell tumor, malignant ovarian germ cell tumor, extragonadal germ cell tumor, malignant germ cell tumor, hepatoblastoma, liver cancer, medulloblastoma, cerebellar astrocytoma, brain stem glioma, glioma, cerebral astrocytoma, ependymoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Solid/brain tumor patients (1-18 years)

Arm Type

Experimental

Arm Description

Patients with solid tumor or brain tumor in the 1-18 years old stratum.

Arm Title

Solid/brain tumor patients (19-45 years)

Arm Type

Experimental

Arm Description

Patients with solid tumor or brain tumor in the 19-45 years old stratum.

Intervention Type

Drug

Intervention Name(s)

amifostine trihydrate

Other Intervention Name(s)

Ethyol

Intervention Description

Patients receive amifostine intravenous (IV) over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1. Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined.

Intervention Type

Drug

Intervention Name(s)

busulfan

Other Intervention Name(s)

Busulfex

Intervention Description

Patients receive oral busulfan every 6 hours on days -8 to -6.

Intervention Type

Drug

Intervention Name(s)

filgrastim

Other Intervention Name(s)

granulocyte colony-stimulating factor, G-CSF

Intervention Description

All patients receive filgrastim (G-CSF) IV for 1 week.

Intervention Type

Drug

Intervention Name(s)

melphalan

Other Intervention Name(s)

Alkeran

Intervention Description

melphalan intravenous (IV) over 30 minutes on days -5 and -4

Intervention Type

Drug

Intervention Name(s)

thiotepa

Other Intervention Name(s)

Thioplex

Intervention Description

thiotepa intravenous (IV) over 2 hours on days -3 and -2.

Intervention Type

Procedure

Intervention Name(s)

peripheral blood stem cell transplantation (PBSC)

Other Intervention Name(s)

bone marrow transplant

Intervention Description

PBSC are reinfused on day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P. Perentesis, MD

Organizational Affiliation

Masonic Cancer Center, University of Minnesota

Official's Role

Study Chair

Facility Information:

Facility Name

University of Minnesota Cancer Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Chordoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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