Brain Tumors Clinical Trial
Official title:
A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who
have leptomeningeal metastases from a solid tumor or lymphoma.
Status | Terminated |
Enrollment | 12 |
Est. completion date | May 2004 |
Est. primary completion date | May 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
- Documented leptomeningeal metastases - Carcinomatous meningitis that is previously untreated or failed prior therapy OR - Lymphomatous meningitis - Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious - Age 18 and over - Karnofsky Performance Status 60-100% - Life expectancy of at least 6 weeks - Absolute neutrophil count greater than 1,500/µL - Platelet count greater than 100,000/µL - Creatinine no greater than 2.0 mg/dL - No congestive heart failure - No unstable angina - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir - No medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting) - No uncontrolled infection - Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed - No other concurrent chemotherapy for other sites of disease - No prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas - No prior radiotherapy to greater than 30% of bone marrow - Prior radiotherapy to the neuroaxis allowed - No concurrent radiotherapy for other sites of disease or for progressive disease - Recovered from any prior recent therapy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | National Cancer Institute (NCI) |
United States,
Davis TH, Fadul CE, Glantz MJ, et al.: Pilot phase II trial of temozolomide for leptomeningeal metastases: preliminary report. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-460, 2003. ISBN 1932312021
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response | Response will be assessed clinically, cytologically, and radiographically. | Every 6 weeks | No |
Secondary | Pharmacokinetics | Drug levels in cerebrospinal fluid assessed every 6 weeks | Every 6 weeks | Yes |
Secondary | Survival | every 6 weeks | No | |
Secondary | Quality of Life | FACT-Br | Baseline, weekly during cycle 1, before each additional cycle | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02846038 -
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
|
||
Completed |
NCT02537106 -
A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation
|
N/A | |
Completed |
NCT01951950 -
Nicardipine vs Esmolol Craniotomy Emergence
|
Phase 1 | |
Completed |
NCT01222780 -
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
|
Phase 1 | |
Completed |
NCT00873184 -
Study of Massage Therapy Within a Brain Tumor Setting
|
N/A | |
Active, not recruiting |
NCT01115777 -
Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies
|
||
Completed |
NCT00003935 -
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
|
Phase 1 | |
Completed |
NCT00724191 -
Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)
|
||
Recruiting |
NCT04128306 -
Brain Areas of Time-To-Contact Perception: an Awake Surgery Study
|
N/A | |
Recruiting |
NCT05202899 -
Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
|
Phase 4 | |
Completed |
NCT00707343 -
[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors
|
Phase 1 | |
Completed |
NCT00850278 -
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
|
N/A | |
Terminated |
NCT00107471 -
Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
|
Phase 1/Phase 2 | |
Completed |
NCT00528437 -
Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors
|
Phase 2 | |
Completed |
NCT00187174 -
Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors
|
Phase 1 | |
Completed |
NCT00135876 -
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
|
Phase 3 | |
Completed |
NCT00062478 -
Study of Karenitecin (BNP1350) in Patients With Brain Tumors
|
Phase 2 | |
Completed |
NCT00241670 -
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
|
Phase 3 | |
Not yet recruiting |
NCT01445691 -
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
|
Phase 2 | |
Terminated |
NCT01018290 -
Navigated Transcranial Magnetic Stimulation in Tumor Surgery
|
N/A |