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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Edward F. McClay, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

San Diego Pacific Oncology & Hematology Associates

Authority:

Unspecified

Study ID:

CDR0000551555

NCT ID:

NCT00492687

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma

Name

Location

San Diego Pacific Oncology and Hematology Associates, Incorporated - EncinitasEncinitas, California  92024