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

NCT00005952 | Completed Phase 1

• 7 other identifiers: 1735DUMC-1735-04-9R5DUMC-1735-02-9R3DUMC-1735-01-9R2DUMC-1833-99-10NCI-G00-1796CDR0000067932
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Overall response at 12 months

• Disease-free survival at 12 months

Secondary Outcomes (2)

• 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

Interventions

filgrastim BIOLOGICAL

temozolomide DRUG

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Head and Neck Neoplasms; Kidney Neoplasms; Neuroblastoma; Ovarian Neoplasms; Sarcoma; Testicular Germ Cell Tumor; Wilms Tumor; Testicular Neoplasms; Nasopharyngeal Neoplasms; Astrocytoma; Oligodendroglioma; Choroid Plexus Neoplasms; Medulloblastoma; Optic Nerve Glioma; Neuroectodermal Tumors, Primitive, Peripheral; Familial ependymoma

Interventions

Filgrastim; Temozolomide; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genital Neoplasms, Male; Genital Diseases, Male; Testicular Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Glioma; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Henry S. Friedman, MD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: June 20, 2013

Record last verified: 2013-02

Locations

US (1)