Status:
COMPLETED
S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Thalidomide may stop the growth of melanoma by blocking blood flow to the tumor. It may also stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in c...
Detailed Description
OBJECTIVES: * Determine the 6-month progression-free survival of patients with unresectable stage IV malignant cutaneous melanoma treated with thalidomide and temozolomide. * Determine the objective ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant cutaneous melanoma
- Unresectable, stage IV disease
- Unknown primary allowed
- Measurable or non-measurable disease
- If all known sites of disease are within a previously irradiated port, disease progression must be clearly demonstrated
- No brain metastases by CT scan or MRI within the past 42 days
- Prior brain metastasis allowed provided both of the following criteria are met:
- Completely resected and free of disease
- Treated with whole brain radiotherapy and completed treatment at least 28 days ago
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL (transfusions allowed)
- Hepatic
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- SGOT or SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- Renal
- Creatinine ≤ 1.5 times ULN
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception for 4 weeks before, during, and for 4 weeks after study participation
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
- No history of allergic reaction to dacarbazine
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior thalidomide for stage IV disease
- At least 28 days since prior biological therapy
- At least 28 days since prior immunotherapy
- At least 28 days since prior adjuvant interferon alfa
- Chemotherapy
- No prior temozolomide or dacarbazine for stage IV disease
- At least 28 days since prior chemotherapy
- Endocrine therapy
- At least 28 days since prior hormonal therapy
- Radiotherapy
- See Disease Characteristics
- At least 28 days since prior radiotherapy
- Surgery
- See Disease Characteristics
- At least 28 days since prior surgery for primary and stage IV disease
- Other
- No more than 1 prior systemic therapy regimen for stage IV disease
- At least 28 days since other prior systemic therapy
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00104988
Start Date
June 1 2005
End Date
August 1 2009
Last Update
August 22 2012
Active Locations (132)
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1
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Eden Medical Center
Castro Valley, California, United States, 94546
4
North Bay Cancer Center
Fairfield, California, United States, 94533