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Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain
This study is ongoing, but not recruiting participants.
First Received: March 3, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00012116
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Temozolomide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Temozolomide For Patients With Cerebral Metastases Who Have Failed Radiation Therapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012116

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Judith M. Ford, MD, PhD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068485, UCLA-0004059, SPRI-UCLA-0004059, NCI-G01-1919
Study First Received: March 3, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00012116     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult tumors metastatic to brain

Study placed in the following topic categories:
Neoplasm Metastasis
Antineoplastic Agents, Alkylating
Central Nervous System Neoplasms
Alkylating Agents
Temozolomide
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Antineoplastic Agents, Alkylating
Central Nervous System Neoplasms
Alkylating Agents
Temozolomide
Pharmacologic Actions
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009