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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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

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Overall response at 12 months

Secondary Outcome

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

Condition

Brain and Central Nervous System Tumors

Intervention

filgrastim


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

30

Start Date

August 2000

Completion Date

November 2005

Primary Completion Date

November 2005

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
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

Henry S. Friedman, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00005952

Organization ID

1735

Secondary IDs

DUMC-1735-04-9R5

Responsible Party

Sponsor

Study Sponsor

Duke University

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Henry S. Friedman, MD, Study Chair, Duke Cancer Institute


Verification Date

February 2013