Please select the eligibility criteria that correspond to the clinical trial below.
Title: Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without temozolomide for glioblastoma multiforme.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.


Options:
A: DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme by biopsy or surgical resection Grade IV disease Initial diagnosis no greater than 6 weeks prior to study

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT less than 2.5 times ULN Alkaline phosphatase less than 2.5 times ULN No chronic hepatitis B or C Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV infection No medical condition that would interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction) No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer No serious medical, psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa No concurrent biologic therapy No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: At least 14 days of prior corticosteroids at a stable dose required Concurrent corticosteroids allowed Radiotherapy: No prior radiotherapy No concurrent stereotactic boost radiotherapy Surgery: See Disease Characteristics No concurrent surgery for tumor debulking Other: No other concurrent investigational drugs
B: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed glioblastoma
* Measurable disease by MRI
* Completed standard first-line treatment for glioblastoma including surgery (unless not received due to anatomical location), radiotherapy and temozolomide (last dose given at least 28 days prior to enrollment)

  * No other prior treatment for glioblastoma except Gliadel or steroids
* Recurrent or progressive disease after standard first-line treatment

  * No disease progression within 3 months of completion of radiotherapy
* No intra- or peri-tumoral hemorrhage

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Mini-mental status score ≥ 15
* Life expectancy ≥ 12 weeks
* Serum bilirubin, ALT/AST, creatinine, and urine protein normal
* Adequate bone marrow reserve
* Not pregnant or nursing
* Normal ECG
* No history of familial long QT syndrome
* No absorption or swallowing difficulties
* No uncontrolled hypertension or cardiac ventricular arrhythmias
* No current or history of uncontrolled hypertension or requiring maximal doses of calcium channel blockers
* No severe or uncontrolled disease
* No history of lung disease
* No recent hemorrhage or hemoptysis
* No known hypersensitivity to cediranib maleate, gefitinib, or any excipients
* No history of other malignancies except adequately treated basal cell or squamous cell carcinoma or carcinoma in situ within the past 5 years, unless disease-free for 2 years with tissue diagnosis
* No known HIV positivity
* No known hepatitis B or C infection
* No unhealed surgical incision
* Not involved in planning or conducting this study

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from prior anticancer therapy, including radiotherapy
* At least 3 months since prior cranial radiation
* At least 30 days since prior investigational drugs
* At least 28 days since prior craniotomy
* At least 2 weeks since prior enzyme-inducing antiepileptic drugs
* At least 2 weeks since prior and no concurrent dexamethasone (\> 8 mg/day) or equivalent
* At least 14 days since prior major surgery or brain biopsy
* No concurrent steroids OR on stable dose 5 days prior to baseline MRI
* No other concurrent anticancer therapy, except for steroids (dexamethasone only)
* No previous enrollment on the current study
* No prior inhibitors of angiogenesis, EGFR, or downstream targets
* No prior radiosurgery or brachytherapy
C: DISEASE CHARACTERISTICS:

* Histopathologically confirmed glioblastoma multiforme

  * Grade IV disease by WHO classification
  * Newly diagnosed disease
* Initial diagnostic surgery or biopsy performed within the past 4 weeks
* Not a candidate for standard radiotherapy (60Gy/30 fractions over 6 weeks) in combination with temozolomide

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* ALT and AST \< 2.5 times ULN
* No known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide
* No history of other malignancies except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years
* No serious active infection (e.g., wound infection requiring parenteral antibiotics) or other serious underlying medical conditions that would preclude study treatment
* No other condition (e.g., psychological or geographical) that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
* No prior radiotherapy
* No prior or concurrent investigational therapy
* No concurrent surgical procedures for tumor debulking
* No concurrent stereotactic boost radiotherapy
* No other concurrent chemotherapy, immunotherapy, or biological therapy
* No concurrent epoetin alfa
* Concurrent corticosteroids allowed provided the patient has been on a stable or decreasing dose for at least 14 days
D: DISEASE CHARACTERISTICS:

* Histologically confirmed glioblastoma multiforme or gliosarcoma

  * Biopsy or surgical resection within the past 28 days

    * MRI\* with gadolinium performed before registration
    * Patients who undergo a simple biopsy only require preoperative MRI\* with gadolinium
* No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)\*
* No prior radiotherapy-delivered cephalad to the interspace between the seventh cervical and the first thoracic vertebral body NOTE: \*If an MRI is not medically feasible, patients may have a CT scan with contrast

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT/SGPT no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN
* PT/PTT no greater than 1.2 times ULN

Renal:

* Not specified

Cardiac:

* No severe cardiac disease, including any of the following:

  * Uncontrolled arrhythmias or conduction defects
  * Major problems with edema (e.g., residual swelling in the legs from deep vein thrombosis)
  * Recent coronary artery disease
  * Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110 mm Hg and/or systolic blood pressure greater than 180 mm Hg)

Pulmonary:

* DLCO at least 70% of predicted
* No severe pulmonary disease

Other:

* HIV negative
* No severe Cushing's syndrome
* No known allergies to any of the study drugs
* No major psychiatric illness
* No poorly controlled diabetes complicated by steroid treatment
* No other medical illness that cannot be adequately controlled or that would preclude study participation
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy
* No other concurrent antitumor chemotherapy

Endocrine therapy:

* No concurrent hormonal therapy except postmenopausal estrogen replacement therapy
* Corticosteroids at stable or decreasing dose for tumor edema allowed

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy
* No other concurrent radiotherapy (including intensity-modulated radiotherapy) to the index lesion(s)

Surgery:

* See Disease Characteristics
* No concurrent antitumor surgery

Other:

* No other concurrent investigational drugs
* No other concurrent antineoplastic drugs or therapy

Answer: A