Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

filgrastim

temozolomide

peripheral blood stem cell transplantation

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring childhood low-grade cerebral astrocytoma, recurrent childhood rhabdomyosarcoma, childhood craniopharyngioma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, stage IV Wilms tumor, stage V Wilms tumor, recurrent Wilms tumor and other childhood kidney tumors, childhood central nervous system germ cell tumor, stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, stage IV nasopharyngeal cancer, recurrent nasopharyngeal cancer, childhood germ cell tumor, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, childhood choroid plexus tumor, untreated childhood brain stem glioma, recurrent childhood brain stem glioma, untreated childhood supratentorial primitive neuroectodermal tumor, recurrent childhood supratentorial primitive neuroectodermal tumor, untreated childhood cerebellar astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, untreated childhood medulloblastoma, recurrent childhood medulloblastoma, untreated childhood visual pathway and hypothalamic glioma, recurrent childhood visual pathway and hypothalamic glioma, previously treated childhood rhabdomyosarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, newly diagnosed childhood ependymoma, recurrent childhood ependymoma

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed malignant glioma or recurrent malignant CNS tumor of any pathology OR Histologically confirmed non-CNS tumor Recurrent soft tissue sarcomas (e.g., rhabdomyosarcoma) Recurrent or resistant neuroblastoma Recurrent Wilm's tumor Recurrent Ewing's sarcoma Recurrent primitive neuroectodermal tumors Recurrent nasopharyngeal carcinoma Recurrent germ cell tumor Expected cure rate less than 10% with standard therapy Measurable and/or active disease History of bone marrow tumor infiltration with or without mass lesions or isolated abnormal CSF cytology as only evidence of recurrent disease allowed if complete response was first achieved with primary conventional therapy PATIENT CHARACTERISTICS: Age: 18 and under Performance status: Karnofsky 70-100% OR Lansky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Reasonably cellular bone marrow (greater than 15% cellularity on biopsy) Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 75,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL SGPT less than 120 U/L Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Systolic fraction or ejection fraction at least 80% predicted for age by echocardiogram Pulmonary: CVC or DLCO at least 60% predicted for age OR clearance from pulmonologist Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active infection Able to tolerate vigorous hydration schedule PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent white blood cell transfusion No other concurrent hematopoietic growth factors Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent cytotoxic drugs (systemic or intrathecal) Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics At least 1 week since prior radiotherapy Surgery: At least 1 week since prior surgery Other: No other concurrent investigational agents

Sites / Locations

Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Overall response at 12 months

Disease-free survival at 12 months

Secondary Outcome Measures

Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months

Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months

Full Information

NCT ID

NCT00005952

First Posted

July 5, 2000

Last Updated

June 19, 2013

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00005952

Brief Title

Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors

Official Title

A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

August 2000 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

No

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. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.

Detailed Description

OBJECTIVES: Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors. Evaluate the toxicity of this treatment in these patients. Determine the activity of this treatment in these patients. OUTLINE: This is a dose escalation study of temozolomide. Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on day -5 and continuing through at least day 3. Peripheral blood stem cells (PBSC) are collected on days 0, 2, and 4. Patients then receive oral temozolomide daily for 5 consecutive days. PBSC collections are reinfused 1 day after the last dose of temozolomide. Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities. Patients are followed every 3 months for 1-3 years, then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.

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, Head and Neck Cancer, Kidney Cancer, Neuroblastoma, Ovarian Cancer, Sarcoma, Testicular Germ Cell Tumor

Keywords

childhood low-grade cerebral astrocytoma, recurrent childhood rhabdomyosarcoma, childhood craniopharyngioma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, stage IV Wilms tumor, stage V Wilms tumor, recurrent Wilms tumor and other childhood kidney tumors, childhood central nervous system germ cell tumor, stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, stage IV nasopharyngeal cancer, recurrent nasopharyngeal cancer, childhood germ cell tumor, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, childhood choroid plexus tumor, untreated childhood brain stem glioma, recurrent childhood brain stem glioma, untreated childhood supratentorial primitive neuroectodermal tumor, recurrent childhood supratentorial primitive neuroectodermal tumor, untreated childhood cerebellar astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, untreated childhood medulloblastoma, recurrent childhood medulloblastoma, untreated childhood visual pathway and hypothalamic glioma, recurrent childhood visual pathway and hypothalamic glioma, previously treated childhood rhabdomyosarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, newly diagnosed childhood ependymoma, recurrent childhood ependymoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Drug

Intervention Name(s)

temozolomide

Intervention Type

Procedure

Intervention Name(s)

peripheral blood stem cell transplantation

Primary Outcome Measure Information:

Title

Overall response at 12 months

Title

Disease-free survival at 12 months

Secondary Outcome Measure Information:

Title

Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months

Title

Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed malignant glioma or recurrent malignant CNS tumor of any pathology OR Histologically confirmed non-CNS tumor Recurrent soft tissue sarcomas (e.g., rhabdomyosarcoma) Recurrent or resistant neuroblastoma Recurrent Wilm's tumor Recurrent Ewing's sarcoma Recurrent primitive neuroectodermal tumors Recurrent nasopharyngeal carcinoma Recurrent germ cell tumor Expected cure rate less than 10% with standard therapy Measurable and/or active disease History of bone marrow tumor infiltration with or without mass lesions or isolated abnormal CSF cytology as only evidence of recurrent disease allowed if complete response was first achieved with primary conventional therapy PATIENT CHARACTERISTICS: Age: 18 and under Performance status: Karnofsky 70-100% OR Lansky 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: Reasonably cellular bone marrow (greater than 15% cellularity on biopsy) Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 75,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL SGPT less than 120 U/L Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Systolic fraction or ejection fraction at least 80% predicted for age by echocardiogram Pulmonary: CVC or DLCO at least 60% predicted for age OR clearance from pulmonologist Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active infection Able to tolerate vigorous hydration schedule PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent white blood cell transfusion No other concurrent hematopoietic growth factors Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent cytotoxic drugs (systemic or intrathecal) Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics At least 1 week since prior radiotherapy Surgery: At least 1 week since prior surgery Other: No other concurrent investigational agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry S. Friedman, MD

Organizational Affiliation

Duke Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Duke Comprehensive Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Head and Neck Cancer

About this trial

Eligibility Criteria

Sites / Locations

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

Learn more about this trial