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

Sponsor:	Duke University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005952

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.

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Head and Neck Cancer Kidney Cancer Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor	Biological: filgrastim Drug: temozolomide Procedure: peripheral blood stem cell transplantation	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Kidney Cancer Neuroblastoma Ovarian Cancer Soft Tissue Sarcoma Wilms' Tumor

Drug Information available for: Temozolomide Filgrastim

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall response at 12 months [ Designated as safety issue: No ]
Disease-free survival at 12 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months [ Designated as safety issue: Yes ]
Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2000

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.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005952

Locations

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

National Cancer Institute (NCI)

Investigators

Study Chair:

Henry S. Friedman, MD

Duke University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067932, DUMC-1735-04-9R5, DUMC-1735-02-9R3, DUMC-1735-01-9R2, DUMC-1833-99-10, NCI-G00-1796
Study First Received:	July 5, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00005952 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Ovarian Diseases
Central Nervous System Neoplasms
Urologic Neoplasms
Neuroblastoma
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms

Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Kidney Diseases
Alkylating Agents
Nervous System Neoplasms
Endocrine Gland Neoplasms
Ovarian Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Temozolomide
Pharmacologic Actions
Adnexal Diseases
Carcinoma

ClinicalTrials.gov processed this record on November 09, 2009