Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas - Full Text View

Sponsored by:	San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00492687

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: carboplatin Drug: tamoxifen citrate Drug: temozolomide Procedure: adjuvant therapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Temozolomide Tamoxifen Tamoxifen citrate Citric acid Sodium Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Tumor response [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	December 2006
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492687

Locations

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 and Hematology Associates, Incorporated - Encinitas

Investigators

Principal Investigator:

Edward F. McClay, MD

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000551555, POHA-0601
Study First Received:	June 25, 2007
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00492687
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
adult glioblastoma

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Citric Acid
Central Nervous System Neoplasms
Carboplatin
Temozolomide
Tamoxifen

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Estrogen Antagonists
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Nervous System Diseases
Neoplasms, Nerve Tissue
Hormones, Hormone Substitutes, and Hormone Antagonists

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009