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


Phase 1/Phase 2
N/A
18 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Head and Neck Cancer, Kidney Cancer, Neuroblastoma, Ovarian Cancer, Sarcoma, Testicular Germ Cell Tumor

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Overall response at 12 months

Safety Issue:

No

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

1735

NCT ID:

NCT00005952

Start Date:

August 2000

Completion Date:

November 2005

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Head and Neck Cancer
  • Kidney Cancer
  • Neuroblastoma
  • Ovarian Cancer
  • Sarcoma
  • Testicular Germ Cell Tumor
  • 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
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Head and Neck Neoplasms
  • Nervous System Neoplasms
  • Neuroblastoma
  • Ovarian Neoplasms
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710