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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00005952
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Henry S. Friedman, MD
Principal Investigator Affiliation Duke Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Head and Neck Cancer, Kidney Cancer, Neuroblastoma, Ovarian Cancer, Sarcoma, Testicular Germ Cell Tumor
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke Comprehensive Cancer Center, Durham, North Carolina

Status

Address

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710

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