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Dose-Intensive Chemotherapy in Combination With Chemoprotected Autologous Stem Cells for Patients With Malignant Gliomas

Complete title: Dose-Intensive Chemotherapy in Combination with Chemoprotected Autologous Stem Cells for Patients with Malignant Gliomas

Research Study Number       2000.00
    
Principal Investigator       Hans-Peter Kiem, MD
    
Phase       I/II

Look up trial at NIH

Research Study Description

This phase I/II trial is studying carmustine and temozolomide when given together with radiation therapy, BCNU, O6-benzylguanine, and an autologous stem cell transplant in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma. Giving chemotherapy, such as temozolomide, carmustine, and O6-benzylguanine, and radiation therapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or plerixafor, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Patients with glioblastoma multiforme or gliosarcoma

- The patient or legal guardian must be able to comprehend the informed consent form and sign prior to patient enrollment

- Patients must be consented for MGMT promoter methylation analysis of brain tumor tissue within twenty-eight days after surgery

- Karnofsky performance status at time of study entry must be >= 70%

- Life expectancy of >= 3 months

- Patients must agree to undergo repeat clinical neurological examinations and brain magnetic resonance imaging (MRI) with appropriate contrast after every other cycle of chemotherapy

- White blood cell (WBC) > 3000/uL

- Absolute neutrophil count (ANC) > 1500/uL

- Platelets > 100,000/uL

- Hemoglobin > 10 gm/100mL

- Total and direct bilirubin < 1.5 times upper limit of laboratory normal

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 3 times upper limit of laboratory normal

- Alkaline phosphatase =< 3 times upper limit of laboratory normal

- Blood urea nitrogen (BUN) < 1.5 times upper limit of laboratory normal

- Serum creatinine < 1.5 times upper limit of laboratory normal

- Left ventricular ejection fraction (LVEF) >= 40%, however, subjects with an LVEF in the range of 40-49% should have cardiology clearance prior to intervention

- MGMT promoter methylation analysis of surgically resected tumor or tumor biopsy must demonstrate an unmethylated or hypomethylated MGMT promoter status

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Patients with cardiac insufficiency and an LVEF of < 40%; history of coronary artery disease or arrhythmia, which has required or requires ongoing treatment

- Patients with active pulmonary infection and/or pulse oximetry < 90% and a corrected diffusion capacity of carbon monoxide (DLCO) < 70% of predicted

- Active systemic infection

- Patients who are human immunodeficiency virus (HIV) positive

- Pregnant or lactating women; a beta-human chorionic gonadotropin (HCG) level will be obtained from women of childbearing potential; fertile men and women should use effective contraception

- Previous chemotherapy for any malignancy including temozolomide, dacarbazine (DTIC) or prior nitrosourea

- Diabetes mellitus

- Bleeding disorder

- Methylated or hypermethylated MGMT promoter status within tumor tissue

- Medical or psychiatric condition which in the opinion of the protocol chairman would compromise the patient's ability to tolerate this protocol

- Prior interstitial radiotherapy, stereotactic or gamma knife surgery or implanted BCNU-wafers

Other exclusion criteria may apply.



Research Study Number       2000.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Brain Cancer; Glioma; Solid Tumors

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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