Gastrointestinal Stromal Tumor Clinical Trial
Official title:
Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
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 unresectable or metastatic gastrointestinal stromal tumors.
OBJECTIVES:
- Determine the complete and partial response (confirmed and unconfirmed) in patients
with unresectable or metastatic gastrointestinal stromal tumors treated with
temozolomide.
- Determine the qualitative or quantitative toxic effects of this regimen in these
patients.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 4 weeks
in the absence of disease progression or unacceptable toxicity. Patients achieving a
confirmed complete response (CR) receive 2 additional courses after a confirmed CR.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 13-27
months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04933669 -
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
|
Phase 2 | |
| Completed |
NCT01769248 -
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
|
N/A | |
| Completed |
NCT01774162 -
EUS-guided Fine Needle Biopsy With a New Core Histology Needle Versus Conventional Fine Needle Aspiration
|
N/A | |
| Completed |
NCT01110668 -
Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
|
Phase 2 | |
| Terminated |
NCT00091078 -
Oblimersen and Imatinib Mesylate in Treating Patients With Advanced Gastrointestinal Stromal Tumors That Cannot Be Removed By Surgery
|
Phase 2 | |
| Completed |
NCT00025246 -
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
|
Phase 2 | |
| Active, not recruiting |
NCT00265798 -
Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate
|
Phase 2 | |
| Recruiting |
NCT04143048 -
A Study on Non-invasive Early Diagnosis of Gastrointestinal Stromal Tumors and Differentiation of Benign and Malignant Nodules
|
||
| Recruiting |
NCT02931981 -
Serum Dickkopf-4 as a Biomarker for the Diagnosis and Treatment of Gastrointestinal Stromal Tumor
|
N/A | |
| Not yet recruiting |
NCT02576080 -
Efficacy of Imatinib in Patients With Intermediate-risk Gastrointestinal Stromal Tumor With a High-risk Genomic Grade Index
|
Phase 3 | |
| Recruiting |
NCT01389583 -
A Study of AUY922 for GIST(Gastrointestinal Stromal Tumor) Patients
|
Phase 2 | |
| Recruiting |
NCT00777504 -
Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
|
Phase 4 | |
| Completed |
NCT00764595 -
Imatinib Mesylate in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
|
Phase 2 | |
| Completed |
NCT00769782 -
Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
|
Phase 2 | |
| Completed |
NCT00098579 -
Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery
|
Phase 1 | |
| Completed |
NCT00005862 -
SU5416 in Treating Patients With Advanced, Metastatic, or Recurrent Soft Tissue Sarcomas
|
Phase 2 | |
| Completed |
NCT00004895 -
Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
|
Phase 2 | |
| Recruiting |
NCT02776878 -
A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST
|
N/A | |
| Completed |
NCT01751919 -
A Clinical Trial to Compare the Pharmacokinetics of Imatinib Mesylate Tablet 400mg (1 Tablet) and Glivec Film-coated Tablet 100mg (4 Tablets)(Phase I)
|
Phase 1 | |
| Completed |
NCT01267695 -
Perioperative Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
|
Phase 2 |