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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer

Study Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining temozolomide, thiotepa, and carboplatin followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have brain cancer.

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 1 Year - 49 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Diagnosis of one of the following malignant brain tumors: - Anaplastic astrocytoma.
  • - Glioblastoma multiforme.
  • - Anaplastic oligodendroglioma.
  • - Medulloblastoma.
  • - High-grade ependymoma.
  • - Germ cell tumors.
  • - Pineoblastoma.
  • - Other primitive neuroectodermal tumors.
  • - Recurrent disease or resistant to conventional therapy (e.g., surgery, radiotherapy, or standard chemotherapy) - No prior myeloablative doses of thiotepa OR.
  • - Newly diagnosed malignant glioma with minimal residual disease after prior radiotherapy.
  • - Minimal residual disease is defined as tumor with maximum diameter of less than 1.5 cm by MRI and no corticosteroid dependency.
PATIENT CHARACTERISTICS: Age:
  • - Over 1 to under 50.
Performance status:
  • - Karnofsky 70-100% OR.
  • - Lansky 70-100% Life expectancy: - More than 12 weeks.
Hematopoietic:
  • - Absolute neutrophil count at least 1,500/mm3.
  • - Platelet count at least 100,000/mm3.
  • - Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT/SGPT less than 2.5 times ULN.
  • - Alkaline phosphatase less than 2.5 times ULN.
Renal:
  • - Creatinine less than 1.5 times ULN.
  • - Creatinine clearance at least 70 mL/min.
  • - BUN less than 1.5 times ULN.
Cardiovascular:
  • - Ejection fraction greater than 50% OR.
  • - Shortening fraction greater than 27% - No evidence of myocardial ischemia on EKG if over 40 years of age.
Other:
  • - HIV negative.
  • - No AIDS-related illness.
  • - No frequent vomiting or medical condition that would preclude oral medication (e.g., partial bowel obstruction) - No other malignancy within the past 2 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - At least 2 weeks since prior biologic therapy or immunotherapy.
Chemotherapy:
  • - See Disease Characteristics.
  • - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered.
Endocrine therapy:
  • - See Disease Characteristics.
Radiotherapy:
  • - See Disease Characteristics.
  • - At least 6 weeks since prior radiotherapy and recovered.
  • - At least 6 weeks since prior brachytherapy or radiosurgery.
Surgery:
  • - See Disease Characteristics.
- Recovered from prior major surgery

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.

NCT00025558
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
Lead Sponsor

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

NYU Langone Health
Principal Investigator

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

Sharon L. Gardner, MD
Principal Investigator Affiliation NYU Langone Health
Agency Class

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

Other, NIH
Overall Status Completed
Countries Australia, United States
Conditions

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

Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Determine the maximum tolerated dose of temozolomide in combination with thiotepa and carboplatin followed by autologous peripheral blood stem cell or bone marrow transplantation in patients with recurrent high-grade brain tumors with minimal residual disease or newly-diagnosed malignant glioma with minimal residual disease following irradiation.
OUTLINE: This is a dose-escalation study of temozolomide. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily for 3 consecutive days. After the third dose of G-CSF, patients undergo leukapheresis to collect peripheral blood stem cells (PBSC). Patients who do not have adequate PBSC may undergo bone marrow harvest. Patients then receive oral temozolomide every 12 hours on days -10 to -6 and thiotepa IV over 3 hours and carboplatin IV over 4 hours on days -5 to -3. PBSC or bone marrow are reinfused on day 0. Beginning on day 1, patients receive G-CSF SC or IV until blood counts recover. 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 preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at day 42, at 3 months, every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study.

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.

New York, New York

Status

Address

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016

Columbus Children's Hospital, Columbus, Ohio

Status

Address

Columbus Children's Hospital

Columbus, Ohio, 43205-2696

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

International Sites

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Status

Address

Princess Margaret Hospital for Children

Perth, Western Australia, 6001