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Status unknownNCT00492687Updated Jan 10, 2014

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

A Phase 2 interventional study of carboplatin and tamoxifen citrate in Brain and Central Nervous System Tumors, sponsored by San Diego Pacific Oncology & Hematology Associates. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-10.

Sponsored by San Diego Pacific Oncology & Hematology Associates · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

  • adult anaplastic astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult glioblastoma
03

In context

Central Nervous System Neoplasms

684 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.

This study's planned enrollment of 80 is above the median of 35 across 474 interventional studies indexed under Central Nervous System Neoplasms.

Browse Central Nervous System Neoplasms studies →

Lead sponsor

San Diego Pacific Oncology & Hematology Associates is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
80 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. Progression-free survival

  2. Overall survival

  3. Toxicity

  4. Tumor response

07

Study locations

1 of 1 sites recruiting
  • San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
    Encinitas, California 92024, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2006 and a primary completion of Jul 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2007
First posted
Jun 27, 2007
Start
Dec 2006
Primary completionEst.
Jul 2009
Last update
Jan 10, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00492687
Lead sponsor
San Diego Pacific Oncology & Hematology Associates
First posted
Jun 27, 2007
Start date
Dec 2006
Primary completion
Jul 2009 (estimated)
Last update
Jan 10, 2014

Study contacts

Edward F. McClay, MD
principal investigator · San Diego Pacific Oncology & Hematology Associates
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Carboplatin · Tamoxifen · Temozolomide

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