Phase II Study of Carboplatin/Etoposide in the Treatment of Anaplastic or Progressive Oligodendrogliomas

Contents:

• Objectives
  • Primary Objectives
  • Secondary Objectives
• Criteria for Patient Eligibility
• Criteria for Patient Ineligibility

OBJECTIVES

1. Primary Objectives:

   • A. To determine the response rate of
     • a) newly diagnosed anaplastic oligodendrogliomas or anaplastic oligoastrocytomas and

     • b) recurrent/progressive oligodendrogliomas or mixed low grade or anaplastic oligoastrocytomas to chemotherapy with Carboplatin/Etoposide.

2. Secondary Objectives

   • A. To determine the toxicity of this regimen, in both previously irradiated patients and those without prior cranial irradiation.

   • B. To determine if histologic parameters of oligodendrogliomas or mixed oligoastrocytomas are predictive of the response to chemotherapy.

CRITERIA FOR PATIENT ELIGIBILITY

1. .Newly-diagnosed, histologically confirmed oligodendroglioma with the pathological diagnosis of
   • a) anaplastic oligodendroglioma or

   • b) anaplastic mixed oligoastrocytoma,

   • c) oligodendroglioma with glioblastoma features that have not received prior radiation therapy.

2. Recurrent or progressive oligodendrogliomas of any of the following histologically confirmed pathologic subtypes at diagnosis or at recurrence . Rebiopsy of recurrent lesions is strongly recommended, but not mandatory:
   • a) anaplastic oligodendroglioma,

   • b) anaplastic mixed oligoastrocytoma,

   • c) low grade oligodendroglioma or

   • d) low grade oligoastrocytoma or

   • e) oligodendroglioma with glioblastoma features.

3. Confirmation of the pathologic diagnosis by two independent neuropathologists.

4. No chemotherapy within the prior 6 weeks.

5. Evidence of measurable disease on contrast enhanced CT or MRI.

6. Greater than 3 months elapsed since the last radiation treatment.

7. Karnofsky performance status > 60.

8. Life expectancy of at least 12 weeks.

9. Age > 18 years old.

10. No pregnancy or lactation.

11. The following baseline tests are required: absolute neutrophil count > 1000/ul, platelet count > 100,000, normal serum creatinine and creatinine clearance. Audiogram showing hearing loss less than 20dB at frequencies greater than equal to 4kHz.

12. All patients must have signed informed consent.

13. No other serious concurrent infection or other medical illness should be present which could jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety.

CONDITIONS FOR PATIENT INELIGIBILITY

1. Prior radiation in those patients with newly-diagnosed oligodendroglioma.

2. Chemotherapy within 6 weeks of protocol chemotherapy.

3. No evidence of measurable disease on post-operative MRI done within 48 hours of surgery.

4. Karnofsky performance score <60.

5. Age less than 18 years old.

6. Pregnancy or lactation.

7. Life expectancy less than 12 weeks.

8. Inability to give informed consent.

9. Baseline hematological, auditory or renal abnormalities, not meeting eligibility criteria.

10. Clinical deterioration without radiographic evidence of tumor recurrence/progression.

11. Any other serious concurrent infection or other medial illness should be present which would jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety.

12. Patients with an active concomitant malignancy other than currently treated carcinoma of the cervix in situ or basal cell carcinoma of the skin.