| ID | Type | Description | Link |
|---|---|---|---|
| 99102 | Other Identifier | UCSF Cancer Center Protocol Number | |
| BTRC-9902 | |||
| H7858-16278-07 | Other Identifier | UCSF IRB |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide | Experimental | Temozolomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide | Drug | Chemotherapy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 from registration until date of the first documented progression, an average of 1 year |
| Safety Profile |
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DISEASE CHARACTERISTICS:
Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:
Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma
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
No known HIV positivity
No AIDS-related illness
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Susan M. Chang, MD | University of California, San Francisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Study of Temozolomide for LGG Patients | Oral temozolomide at 200mg/m2 per day x5 days every 28 days for up to 12 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide | Single Arm Trial with single dose schedule of Temozolomide chemotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Temozolomide | Temozolomide temozolomide: Chemotherapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils/granulocytes (ANC) | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Metabolism and nutrition disorders | Systematic Assessment | Constitutional Symptoms: Fatigue (asthenia, lethargy, malaise) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Chang MD | UCSF Neuro-Oncology | 415-353-2966 | Susan.Chang@ucsf.edu |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0 |
| Time from registration up to 13 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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. | Posted | Median | 95% Confidence Interval | years | time from registration until date of the first documented progression, an average of 1 year |
|
|
|
| Secondary | Safety Profile | Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0 | Posted | Count of Participants | Participants | Time from registration up to 13 months |
|
|
|
| 17 |
| 120 |
| 31 |
| 120 |
| Thrombocytopenia (platelets) | Blood and lymphatic system disorders | Systematic Assessment | Grade 4 |
|
| Infection with unknown ANC | Infections and infestations | Systematic Assessment |
|
| seizure | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Systematic Assessment | Grade III |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Grade III |
|
| Death | Nervous system disorders | Systematic Assessment | Death within 30 days of study drug - unlikely related to study drug |
|
|
| Nausea | Gastrointestinal disorders |
|
| SGPT (ALT) (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders |
|
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders |
|
| Seizures | Nervous system disorders | Neurology |
|
| Alkaline phosphatase | Metabolism and nutrition disorders |
|
| Tremor | Nervous system disorders |
|
| Weight loss | Metabolism and nutrition disorders |
|
| Anorexia | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Lymphopenia | Blood and lymphatic system disorders |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders |
|
| Platelets | Blood and lymphatic system disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Insomnia | Nervous system disorders |
|
| Infection with unknown ANC | Infections and infestations |
|
| Memory loss | Nervous system disorders | Memory impairment |
|
| Transfusion: Platelets | Blood and lymphatic system disorders |
|
| GGT (γ-Glutamyl transpeptidase) | Metabolism and nutrition disorders |
|
| Neuropathy: cranial | Nervous system disorders |
|
| Pain - Other | General disorders |
|
| Hemoglobin | Blood and lymphatic system disorders |
|
| Rash: dermatitis associated with high-dose chemotherapy or BMT studies | Skin and subcutaneous tissue disorders |
|
| Infection without neutropenia | Infections and infestations |
|
| Hyperglycemia | Metabolism and nutrition disorders | Glucose, serum-high (hyperglycemia) |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders |
|
| Taste alteration (dysgeusia) | Gastrointestinal disorders |
|
| Personality/behavioral | Nervous system disorders |
|
| Mood alteration - depression | Nervous system disorders |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders |
|
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | Mucositis/stomatitis |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Wound-infectious | Infections and infestations | Infection - Select |
|
| diarrhea patients without colostomy | Gastrointestinal disorders | diarrhea |
|
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| D018302 |
| Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |