NCT00492687

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

January 10, 2014

Status Verified

July 1, 2009

Enrollment Period

2.6 years

First QC Date

June 25, 2007

Last Update Submit

January 9, 2014

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytomaadult giant cell glioblastomaadult gliosarcomaadult glioblastoma

Outcome Measures

Primary Outcomes (4)

  • Progression-free survival

  • Overall survival

  • Toxicity

  • Tumor response

Interventions

carboplatinDRUG
tamoxifen citrateDRUG
temozolomideDRUG
adjuvant therapyPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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 PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the head and neck * No other concurrent therapy for the tumor

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Encinitas, California, 92024, United States

RECRUITING

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytomaGlioblastomaGliosarcoma

Interventions

CarboplatinTamoxifenTemozolomideChemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsDacarbazineTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Edward F. McClay, MD

    San Diego Pacific Oncology & Hematology Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

December 1, 2006

Primary Completion

July 1, 2009

Last Updated

January 10, 2014

Record last verified: 2009-07

Locations

US(1)