Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Cancer and Leukaemia Group
• Treatments: Cisplatin; Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of 1 of the following grade III or grade IV malignant glial tumors*:

• Glioblastoma

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Anaplastic oligoastrocytoma

• Anaplastic ganglioglioma

• Anaplastic mixed tumor

• Glial component is essential NOTE: *Malignant gliomas occurring as a second primary malignancy allowed

• Newly diagnosed or recurrent disease

• No malignant brain stem tumors

• Incompletely resected tumors

• No completely resected tumors

• Measurable or evaluable disease by conventional MRI

PATIENT CHARACTERISTICS:

• Lansky performance status 40-100%

• Organ toxicity ≤ grade 2

• Absolute neutrophil count ≥ 1,000/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 2.5 times ULN

• Prothrombin ≥ 50%

• Fibrinogen ≥ 1.5 g/L

• Creatinine normal for age

• Creatinine ≤ 65 µmol/L (4-15 years of age)

• Creatinine ≤ 110 µmol/L (15-20 years of age)

• Audiogram with toxicity grade ≤ 2

• ECG normal

• Negative pregnancy test

• Fertile patients must use effective contraception

• No severe or life-threatening infection

• No uncontrolled developing or symptomatic intracranial hypertension

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) or radiotherapy for patients with relapsed disease

• No prior cisplatin or temozolomide

• No other concurrent anticancer therapy