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BMS-247550 in Treating Patients With 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 using a real mD. We aren't mDs. Always confer with your physician on BMS-247550 in Treating Patients With Stage IV Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Stage IV Melanoma Clinical research trials and BMS-247550 in Treating Patients With Stage IV Melanoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as BMS-247550 in Treating Patients With Stage IV Melanoma. BMS-247550 in Treating Patients With Stage IV Melanoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a BMS-247550 in Treating Patients With Stage IV Melanoma clinical trial. Human subjects often receive the most effective healthcare possible for their BMS-247550 in Treating Patients With Stage IV Melanoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Stage IV Melanoma  BMS-247550 in Treating Patients With Stage IV Melanoma
BMS-247550 in Treating Patients With Stage IV Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): Kaplan 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. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage IV melanoma.
Details: OBJECTIVES: - Determine the efficacy of BMS-247550 in patients with stage IV melanoma. - Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to the number of prior chemotherapy regimens (0 vs 1-2, including dacarbazine or temozolomide). Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 23-88 patients (11-50 who have not received prior chemotherapy and 12-38 who have received prior chemotherapy) will be accrued for this study within 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed stage IV melanoma - At least 1 measurable lesion - Greater than 20 mm by conventional techniques OR - Greater than 10 mm by spiral CT scan - Known brain metastases allowed if all of the following criteria are met: - Radiologically stable for at least 6 weeks after completion of whole brain radiotherapy - Stable at time of study - No mass effect present radiologically - No concurrent steroids to control symptoms of brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal (ULN) Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior severe allergic reactions (grade III or IV or grade II not responsive to steroids) to taxanes or medications containing Cremophor EL - No pre-existing grade 2 or greater peripheral neuropathy - No HIV-positive patients receiving combination antiretroviral therapy - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior vaccine therapy allowed - Prior immunotherapy (e.g., interleukin-2 or interferon) allowed Chemotherapy: - Stratum I: - No prior chemotherapy - Stratum II: - No more than 2 prior chemotherapy regimens (must have included dacarbazine or temozolomide) Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics Surgery: - Not specified Other: - Prior limb-perfusion therapy allowed (stratum II) - No other concurrent investigational or commercial agents or therapies intended to treat malignancy - No concurrent Hypericum perforatum
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnaPavlick, Study Chair, Kaplan Cancer Center
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
New York Weill Cornell Cancer Center at Cornell University
New York City, New York, 10021
United States
Austin Hospital
Heidelberg, Victoria, 3084
Australia
Royal Prince Alfred Hospital, Sydney
Sydney, New South Wales, 2050
Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050
Australia
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Additional Information:
Study ID Numbers: CDR0000069320; NCI-4470,NYU-0057
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036764
Other Stage 4 Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage IV Melanoma
2. O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma
3. Interferon alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin
4. Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
5. Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Victoria Clinical Trials
Other Parkville Clinical Trials
BMS-247550 in Treating Patients With Stage IV Melanoma
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