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Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas

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ClinicalTrials.gov Identifier: NCT00492687
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : June 27, 2007
Last Update Posted : January 10, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tamoxifen may make tumor cells more sensitive to radiation therapy and chemotherapy. Giving radiation therapy together with temozolomide, tamoxifen, and carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving radiation therapy together with temozolomide, tamoxifen, and carboplatin works in treating patients with malignant gliomas.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: carboplatin Drug: tamoxifen citrate Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the progression-free and overall survival of patients with supratentorial malignant gliomas (WHO grade III or IV) receiving radiotherapy with concurrent and adjuvant temozolomide, tamoxifen citrate, and carboplatin.
  • Determine the acute and delayed treatment-related toxicities in these patients.
  • Determine tumor response in patients with postoperative measurable disease.

OUTLINE: This is an open-label, pilot study.

  • Induction therapy: Patients receive oral temozolomide twice daily and oral tamoxifen citrate twice daily on days 1-42 and carboplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also receive radiotherapy on days 1-5 in weeks 1-6.
  • Consolidation therapy: Beginning 4 weeks after the completion of induction therapy, patients receive temozolomide, tamoxifen citrate, and carboplatin as in induction therapy. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Pilot Trial of Radiation Therapy With Concurrent and Adjuvant Temozolomide, Tamoxifen and Carboplatin (T2C) in the Treatment of Patients With Primary Central Nervous System Malignant Gliomas
Study Start Date : December 2006
Estimated Primary Completion Date : July 2009

Primary Outcome Measures :
  1. Progression-free survival
  2. Overall survival
  3. Toxicity
  4. Tumor response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed glioblastoma multiforme and/or anaplastic astrocytoma

    • Supratentorial tumor
    • No well-differentiated astrocytoma or glioma with oligodendroglial component
    • No multifocal glioma
  • Has undergone surgery within the past 6 weeks
  • No recurrent glioblastoma multiforme


  • ECOG performance status 0-2
  • Neurological functional status 0-2
  • Life expectancy > 12 weeks
  • ANC ≥ 1,200/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Blood urea nitrogen ≤ 1.5 times ULN
  • Total and direct bilirubin ≤ 3 times ULN
  • AST and ALT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study completion
  • No other malignancies within the past 3 years, except for carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No acquired immune deficiency syndrome (AIDS)
  • No major medical illness or psychiatric impairment that would preclude study compliance


  • No prior radiotherapy to the head and neck
  • No other concurrent therapy for the tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492687

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United States, California
San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas Recruiting
Encinitas, California, United States, 92024
Contact: Edward F. McClay, MD    760-452-3340    emcclay@pacificoncology.com   
Sponsors and Collaborators
San Diego Pacific Oncology & Hematology Associates
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Principal Investigator: Edward F. McClay, MD San Diego Pacific Oncology & Hematology Associates
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ClinicalTrials.gov Identifier: NCT00492687    
Other Study ID Numbers: CDR0000551555
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
adult glioblastoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents