A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain
Overview
- Phase
- Phase 2
- Intervention
- temozolomide
- Conditions
- Recurrent Melanoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Response rate (defined as complete or partial)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells
Detailed Description
OBJECTIVES: Primary I. Determine the objective response rate in patients with brain metastases secondary to melanoma treated with temozolomide and thalidomide. Secondary I. Determine the toxic effects of and tolerance to this regimen in these patients. II. Determine the objective response rate in extracranial metastases of patients treated with this regimen. III. Determine the time to first disease progression (intra- or extracranial) in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 2 years. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 1.5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed metastatic melanoma
- •Clinical evidence of brain metastases
- •At least 1 unidimensionally measurable brain lesion at least 2.0 cm by conventional techniques OR at least 1.0 cm by spiral CT scan or MRI
- •The following lesions are not considered measurable:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (temozolomide, thalidomide)
Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses of therapy beyond CR.
Intervention: temozolomide
Treatment (temozolomide, thalidomide)
Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses of therapy beyond CR.
Intervention: thalidomide
Outcomes
Primary Outcomes
Response rate (defined as complete or partial)
Time Frame: Up to 5 years
90% confidence intervals will be used.
Secondary Outcomes
- Time to first progression(Up to 5 years)
- Overall survival(Up to 5 years)