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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00492687
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 San Diego Pacific Oncology & Hematology Associates
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Edward F. McClay, MD
Principal Investigator Affiliation San Diego Pacific Oncology & Hematology Associates
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Encinitas, California

Status

Recruiting

Address

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Encinitas, California, 92024

Site Contact

Edward F. McClay, MD

[email protected]

760-452-3340

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