Recruiting
Phase 2

Radiation Therapy, Temozolomide, Tamoxifen, Carboplatin

Sponsor:

San Diego Pacific Oncology & Hematology Associates

Code:

NCT00492687

Conditions

Brain and Central Nervous System Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

carboplatin

tamoxifen citrate

temozolomide

adjuvant therapy

radiation therapy

Study Details

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.

Conditions

Brain and Central Nervous System Tumors

Study ID

NCT00492687

Start date

Dec, 2006

Status verified date

Jul, 2009

Primary completion date

Jul, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

carboplatin

tamoxifen citrate

temozolomide

adjuvant therapy

radiation therapy

Primary outcome measure

  • Progression-free survival [ Time Frame: undefined ]
  • Overall survival [ Time Frame: undefined ]
  • Toxicity [ Time Frame: undefined ]
  • Tumor response [ Time Frame: undefined ]

Central Contacts and Locations

Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Recruiting

Encinitas, California, United States, 92024

Contacts

Edward F. McClay, MD

760-452-3340emcclay@pacificoncology.com

More Information

Sponsor

San Diego Pacific Oncology & Hematology Associates

Last update posted

Jan 10, 2014

Last verified

Jul, 2009

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by San Diego Pacific Oncology & Hematology Associates on 2014-01-10.