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Tracking Information | |||||
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First Received Date † | March 3, 2001 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date † | October 2000 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00012116 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain | ||||
Official Title † | Temozolomide For Patients With Cerebral Metastases Who Have Failed Radiation Therapy | ||||
Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain. |
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Detailed Description | OBJECTIVES: I. Assess the response rate of patients with cerebral metastases who have failed or refused standard therapy when treated with temozolomide. II. Assess the safety and tolerability of this drug in these patients. III. Determine the quality of life of patients treated with this drug. IV. Determine the response rate of systemic disease outside the central nervous system in patients treated with this drug. OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Treatment repeats every 10 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed on day 1 of each 10-week course. Patients are followed for 30 days. PROJECTED ACCRUAL: A total of 18-48 patients will be accrued for this study within 2 years. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Brain and Central Nervous System Tumors | ||||
Intervention † | Drug: temozolomide | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS: Histologically confirmed advanced solid malignancy with imaging evidence of progressive brain metastases Failed or refused surgery, whole brain radiotherapy, and/or stereotactic radiosurgery No lymphoma Systemic disease allowed (if uncontrolled, must be less life-threatening than brain metastases) Bidimensionally measurable brain disease by MRI Previously treated lesions must show progression and be measurable No known carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine less than 1.5 times ULN BUN less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV infection No other malignancy within the past 2 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin No other serious medical condition No acute infection treated with IV antibiotics No frequent vomiting or other medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic therapy or immunotherapy and recovered No concurrent growth factors administered for the purpose of continuing temozolomide No concurrent epoetin alfa Chemotherapy: Prior adjuvant chemotherapy allowed Prior chemotherapy for metastatic disease allowed At least 4 weeks since prior chemotherapy except vincristine (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Prior and concurrent steroids allowed if neurologically stable or improving Concurrent hormonal therapy allowed for stable breast cancer Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy or interstitial brachytherapy (4 weeks for brain radiotherapy) and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 1 week since prior surgery and recovered Other: At least 4 weeks since prior systemic therapy No other concurrent investigational agents |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00012116 | ||||
Responsible Party | |||||
Secondary IDs †† | UCLA-0004059, SPRI-UCLA-0004059, NCI-G01-1919 | ||||
Study Sponsor † | Jonsson Comprehensive Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | June 2002 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |