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Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma Clinical research trials and Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma. Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma  Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
For Condition: Melanoma,intraocular melanoma
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 I/II 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic malignant melanoma that is considered unresectable - Stage III or IV ocular, mucosal, or cutaneous melanoma - Measurable disease - No CNS disease (phase I only) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT/SGPT no greater than 3 times ULN - Alkaline phosphatase no greater than 3 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No history of active angina - No myocardial infarction within past 6 months - No history of significant ventricular arrhythmia requiring medication with antiarrhythmics Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 4 weeks before and after study - No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction) - No preexisting neurotoxicity grade 2 or greater - No serious concurrent infections treated with antibiotics - No nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study - No psychiatric disorders that would preclude study compliance - No other medical condition or reason that would preclude study - No other malignancy within the past 2 years except: - Nonmelanoma skin cancer - Carcinoma in situ of the cervix - History of T1a or b prostate cancer detected incidentally at TURP and comprising less than 5% of resected tissue with PSA normal since TURP - No AIDS related illness - HIV negative PRIOR CONCURRENT THERAPY: - Recovered from prior therapy Biologic therapy: - At least 4 weeks since prior biologic therapy - At least 4 weeks since prior immunotherapy - No concurrent immunotherapy Chemotherapy: - No prior systemic chemotherapy for metastatic melanoma - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery - At least 3 weeks since prior radiotherapy to the brain if brain metastases from melanoma - Prior radiotherapy to only indicator lesion allowed provided recent evidence of disease progression at that site - No concurrent radiotherapy Surgery: - At least 2 weeks since prior surgery requiring general anesthesia
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Wen-JenHwu, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067818; MSKCC-99103,NCI-G00-1786
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005815
Other Intraocular Melanoma Studies:
1. Study of ILX651 in Patients with Inoperable Locally Advanced or Metastatic Melanoma
2. A Phase III Multi-Institutional Randomized Study of Immunization with the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients with Metastatic Melanoma
3. Study of Karenitecin (BNP1350) to treat Malignant Melanoma
4. Vaccine Treatment for Advanced Melanoma
5. ADI-PEG in Patients With Metastatic Melanoma
Related Studies:
Other intraocular melanoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
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