Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005815
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-06-02
Brief Title:
Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase III Study of Temozolamide and Thalidomide in the Treatment of Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Thalidomide may stop the growth of melanoma by stopping blood flow to the tumor Combining chemotherapy with thalidomide may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness temozolomide plus thalidomide in treating patients who have stage III or stage IV melanoma that cannot be removed during surgery
PURPOSE Phase III trial to study the effectiveness temozolomide plus thalidomide in treating patients who have stage III or stage IV melanoma that cannot be removed during surgery
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of temozolomide using an extended continuous schedule in combination with thalidomide in patients with advanced melanoma
Determine the response rate to this combination using an extended continuous schedule at the MTD in 30 patients who have advanced metastatic melanoma without brain metastases and in 15 patients who have metastatic melanoma in the brain
Further characterize the safety and toxicity of this combination in these patients
OUTLINE This is a dose escalation study of temozolomide phase I followed by a response rate determination study phase II
Patients receive oral temozolomide daily for 6 weeks followed by 2-4 weeks of rest Patients receive oral thalidomide daily for the entire 8-10 week course Treatment continues in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Once the MTD is determined additional patients are accrued to receive treatment with temozolomide and thalidomide at the recommended phase II dose
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for phase I and then an additional 45 patients 15 with CNS disease 30 without CNS disease will be accrued for phase II of this study within 18 months
Determine the maximum tolerated dose MTD of temozolomide using an extended continuous schedule in combination with thalidomide in patients with advanced melanoma
Determine the response rate to this combination using an extended continuous schedule at the MTD in 30 patients who have advanced metastatic melanoma without brain metastases and in 15 patients who have metastatic melanoma in the brain
Further characterize the safety and toxicity of this combination in these patients
OUTLINE This is a dose escalation study of temozolomide phase I followed by a response rate determination study phase II
Patients receive oral temozolomide daily for 6 weeks followed by 2-4 weeks of rest Patients receive oral thalidomide daily for the entire 8-10 week course Treatment continues in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Once the MTD is determined additional patients are accrued to receive treatment with temozolomide and thalidomide at the recommended phase II dose
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for phase I and then an additional 45 patients 15 with CNS disease 30 without CNS disease will be accrued for phase II of this study within 18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1786 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067818 | REGISTRY | None | None |