Brain and Central Nervous System Tumors
Conditions
Keywords
recurrent adult brain tumor, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult subependymal giant cell astrocytoma, adult anaplastic ependymoma, adult ependymoma, adult myxopapillary ependymoma, adult subependymoma, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult brain stem glioma, adult mixed glioma, adult pineal gland astrocytoma
Brief summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant glioma.
Detailed description
OBJECTIVES: Primary * Determine the progression-free survival rate at 6 months in patients with recurrent glioblastoma multiforme or other malignant glioma treated with temozolomide. Secondary * Determine the overall survival of patients treated with this drug. OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and every 2 months for 2 years for evaluation of markers of neo-angiogenesis. Samples are analyzed by protein expression, reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected and tested as of 1/12/09)
Interventions
DRUGtemozolomide
GENETICprotein expression analysis
GENETICreverse transcriptase-polymerase chain reaction
OTHERdiagnostic laboratory biomarker analysis
OTHERimmunoenzyme technique
Sponsors
National Cancer Institute (NCI)
Weill Medical College of Cornell University
Schering-Plough
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Pathologically diagnosed glioblastoma multiforme or other malignant glioma * Recurrent disease * Must have received prior temozolomide PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * SGOT ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 2 times ULN * Bilirubin ≤ 2 times ULN * No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin * No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment * No medical condition that precludes swallowing pills * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) Rate at 6 Months | at 6 months | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years | All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Temozolomide Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Temozolomide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 47 |
| serious Total, serious adverse events | 14 / 47 |
Outcome results
Primary
Progression-free Survival (PFS) Rate at 6 Months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: at 6 months
Population: Glioblastoma patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Temozolomide | Progression-free Survival (PFS) Rate at 6 Months | 19 percentage of participants |
Secondary
Overall Survival
All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. The dose of gadolinium must be held constant from scan to scan. Macdonald criteria will be used for assessment of tumor response.
Time frame: 2 years
Population: Glioblastoma patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Temozolomide | Overall Survival | 7 months |