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

June 19, 2013 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall response at 12 months
Disease-free survival at 12 months

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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 (Other Identifier: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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