CNS Tumor, Adult
Conditions
Keywords
adult oligodendroglioma, adult mixed glioma, adult diffuse astrocytoma, adult pilocytic astrocytoma, 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 supratentorial low-grade glioma.
Detailed description
OBJECTIVES: Primary * Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma. Secondary * Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma. * Assess the time to tumor progression in patients treated with temozolomide. OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Interventions
DRUGtemozolomide
Chemotherapy
Sponsors
University of California, San Francisco
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: * Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes: * Oligodendroglioma * Astrocytoma * Oligoastrocytoma * Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma * Study treatment must begin between 14 days and 4 months after surgical resection or biopsy * Evaluable disease by gadolinium-MRI PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine \< 1.5 times upper limit of normal (ULN) * BUN \< 1.5 times ULN * Bilirubin \< 1.5 times ULN * SGOT \< 2.5 times ULN * Alkaline phosphatase \< 2 times ULN * Life expectancy \> 12 weeks * No nonmalignant systemic disease resulting in the patient being a poor medical risk * No acute infection requiring intravenous antibiotics * No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) * No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin * Prior malignancies must be in remission for ≥ 5 years * No known HIV positivity * No AIDS-related illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma * No prior biological therapy or chemotherapy for low-grade glioma * No other concurrent chemotherapy * No concurrent radiotherapy or biological therapy * No concurrent prophylactic growth factors * No concurrent epoetin alfa * No other concurrent investigational drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate (Complete and Partial Response) | 12 months | Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was definitely better than prior scan with stable or improved neuro exam and steroids. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Tumor Progression | time from registration until date of the first documented progression, an average of 1 year | Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria. |
| Safety Profile | Time from registration up to 13 months | Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Temozolomide Single Arm Trial with single dose schedule of Temozolomide chemotherapy | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | Temozolomide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 120 |
| serious Total, serious adverse events | 17 / 120 |
Outcome results
Primary
Response Rate (Complete and Partial Response)
Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was definitely better than prior scan with stable or improved neuro exam and steroids.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Temozolomide | Response Rate (Complete and Partial Response) | 7 Participants |
Secondary
Safety Profile
Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0
Time frame: Time from registration up to 13 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Temozolomide | Safety Profile | 12 Participants |
Secondary
Time to Tumor Progression
Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.
Time frame: time from registration until date of the first documented progression, an average of 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Temozolomide | Time to Tumor Progression | 3.8 years |