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

Primary Purpose

Brain and Central Nervous System Tumors

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

carboplatin

tamoxifen citrate

temozolomide

adjuvant therapy

radiation therapy

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - EncinitasRecruiting

Outcomes

Primary Outcome Measures

Progression-free survival

Overall survival

Toxicity

Tumor response

Secondary Outcome Measures

Full Information

NCT ID

NCT00492687

First Posted

June 25, 2007

Last Updated

January 9, 2014

Sponsor

San Diego Pacific Oncology & Hematology Associates

1. Study Identification

Unique Protocol Identification Number

NCT00492687

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2006 (undefined)

Primary Completion Date

July 2009 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

San Diego Pacific Oncology & Hematology Associates

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Type

Drug

Intervention Name(s)

tamoxifen citrate

Intervention Type

Drug

Intervention Name(s)

temozolomide

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Primary Outcome Measure Information:

Title

Progression-free survival

Title

Overall survival

Title

Toxicity

Title

Tumor response

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward F. McClay, MD

Organizational Affiliation

San Diego Pacific Oncology & Hematology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edward F. McClay, MD

Phone

760-452-3340

emcclay@pacificoncology.com

12. IPD Sharing Statement

Learn more about this trial

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

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