Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

OBJECTIVES:

- Determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide.

- Determine adverse events related to this regimen in this patient population.

- Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients.

OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression.

Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response.

Quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter.

PROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00005812
Study type Interventional
Source Dartmouth-Hitchcock Medical Center
Contact
Status Terminated
Phase Phase 2
Start date January 2000
Completion date May 2004

See also
  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 NCT00724191 - Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)
Completed NCT00003935 - Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma Phase 1
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