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Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme

This study has been completed.

Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006388
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as tamoxifen may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: tamoxifen citrate
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Tamoxifen    Tamoxifen citrate    Citric acid    Sodium Citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of High Dose Tamoxifen For The Treatment of Newly Diagnosed Supratnetorial Glioblastoma Multiforme (GBM)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 2000

Detailed Description:

OBJECTIVES: I. Determine whether high-dose tamoxifen initiated at the beginning of conventional radiotherapy improves the median survival time of adults with newly diagnosed, supratentorial glioblastoma multiforme. II. Determine the feasibility and toxicity of high-dose tamoxifen in these patients. III. Determine the overall survival with respect to protein kinase C lab correlates in patients treated with this regimen.

OUTLINE: This is a multicenter study. Beginning within 5 weeks after surgery, patients undergo radiotherapy to the brain 5 days a week for 6 weeks. Patients receive high-dose oral tamoxifen every 6 hours beginning on day 1 of radiotherapy and continuing in the absence of disease progression. Patients are followed every 3 months through year 1, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 6 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven newly diagnosed, supratentorial glioblastoma multiforme (with areas of necrosis) Diagnosis must be made by surgical biopsy or excision within the past 5 weeks No recurrent malignant gliomas No metastases below the tentorium or beyond the cranial vault

PATIENT CHARACTERISTICS: Age: Adult Performance status: Karnofsky 70-100% OR Zubrod 0-1 Life expectancy: At least 8 weeks Hematopoietic: Hemoglobin at least 10 g/dL (transfusion allowed) Hematocrit at least 30% (transfusion allowed) Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGPT or SGOT no greater than 2 times normal Renal: Blood urea nitrogen no greater than 25 mg/dL Creatinine no greater than 1.5 mg/dL Cardiovascular: No active thrombophlebitis Other: Recovered from any postoperative infection or other complications No major medical illnesses or psychiatric impairments that would preclude study participation No active connective tissue disorder, such as lupus or scleroderma No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or bladder No prior endometrial cancer or atypical endometrial hyperplasia No AIDS Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 12 months since prior tamoxifen Radiotherapy: See Disease Characteristics No prior radiotherapy to head or neck Surgery: See Disease Characteristics Recovered from prior surgery

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006388

Show 257 study locations  Show 257 Study Locations

Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     H. I. Robins, MD, PhD     University of Wisconsin, Madison    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Robins HI, Won M, Seiferheld WF, Schultz CJ, Choucair AK, Brachman DG, Demas WF, Mehta MP. Phase 2 trial of radiation plus high-dose tamoxifen for glioblastoma multiforme: RTOG protocol BR-0021. Neuro-oncol. 2006 Jan;8(1):47-52.
 
Robins HI, Won M, Schultz C, et al.: A phase II trial of conventional radiation therapy (XRT) plus high dose tamoxifen (TAM) for the treatment of supratentorial glioblastoma multiforme (GBM): RTOG protocol BR-0021. [Abstract] J Clin Oncol 22 (Suppl 14): A-1529, 114s, 2004.
 

Study ID Numbers:   CDR0000068266, RTOG-BR-0021, RTOG-DEV-1015
First Received:   October 4, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006388
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma  
adult giant cell glioblastoma  
adult gliosarcoma  

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Citric Acid
Central Nervous System Neoplasms
Tamoxifen
Neuroectodermal Tumors
Glioblastoma multiforme
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Estrogen Antagonists
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on December 03, 2008




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