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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00005952
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 30
• Location: 1
• Duration (Months): 63
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	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 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Primary Purpose: Treatment
• Official Title: A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors
• Study Start Date: Aug 1, 2000
• Actual Primary Completion Date: Nov 1, 2005
• Actual Study Completion Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

1. Overall response at 12 months []

2. Disease-free survival at 12 months []

Secondary Outcome Measures

1. Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months []

2. Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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 Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00005952
• Other Study ID Numbers: 1735; DUMC-1735-04-9R5; DUMC-1735-02-9R3; DUMC-1735-01-9R2; DUMC-1833-99-10; NCI-G00-1796; CDR0000067932
• First Posted: Jan 27, 2003
• Last Update Posted: Jun 20, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Duke University: 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
• Additional relevant MeSH terms: Neoplasms; Sarcoma; Neuroblastoma; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms; Temozolomide

Study Results

No Results Posted as of Jun 20, 2013