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Cilengitide in Treating Patients With Metastatic Melanoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Cilengitide in Treating Patients With Metastatic Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Cilengitide in Treating Patients With Metastatic Melanoma Clinical research trials and Cilengitide in Treating Patients With Metastatic Melanoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Cilengitide in Treating Patients With Metastatic Melanoma. Cilengitide in Treating Patients With Metastatic Melanoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Cilengitide in Treating Patients With Metastatic Melanoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Cilengitide in Treating Patients With Metastatic Melanoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cilengitide in Treating Patients With Metastatic Melanoma  Cilengitide in Treating Patients With Metastatic Melanoma
Cilengitide in Treating Patients With Metastatic Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Not yet recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Cilengitide may stop the growth of melanoma by stopping blood flow to the tumor. PURPOSE: Randomizedphase II trial to study the effectiveness of cilengitide in treating patients who have metastatic melanoma.
Details: OBJECTIVES: Primary - Determine the clinical efficacy of cilengitide at 2 different doses, in terms of the 8-week progression-free survival rate, in patients with metastatic melanoma. Secondary - Determine the response rate in patients treated with this drug. - Determine the overall survival rate of patients treated with this drug. - Determine the safety and toxicity of this drug in these patients. - Determine the population pharmacokinetics of this drug in these patients. - Determine the biological activity of this drug in these patients. OUTLINE: This is a randomized, double-blind study. Patients are stratified according to prior systemic treatment (yes vs no), visceral metastases (yes vs no), serum lactic dehydrogenase level (normal vs abnormal), and tumor integrin α_vβ_3 overexpression (yes vs no). Patients are randomized into 1 of 2 treatment arms. - Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11*, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: *For the first course only, treatment is omitted on day 11 - Arm II: Patients receive cilengitide as in arm I at a higher dose. Patients are followed at 1 month, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 20-44 patients (10-22 per treatment arm) will be accrued for this study within 14-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic melanoma - Stage IV disease - Cutaneous, mucosal, or unknown origin - Measurable disease - At least one unidimensional lesion 15 mm by conventional techniques or spiral CT scan - In case of obviously visible cutaneous metastatic lesions, at least one unidimensional lesion 10 mm with clearly defined margins - No metastatic melanoma of choroidal origin - No known brain metastases - Patients who have no radiographical evidence of recurrence in the brain for at least 3 months after prior complete resection of brain metastases OR who have asymptomatic brain metastases that are stable for at least 3 months after prior whole brain radiotherapy and/or stereotactic radiosurgery AND do not require steroids are eligible PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - WBC 3,000/mm^3 - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - Hemoglobin 9 g/dL (transfusion allowed) Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) - ALT 2.5 times ULN Renal - Creatinine 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia, including LOWN IV arrhythmia (defined as 2 or more consecutive ventricular premature complexes) - No advanced coronary artery disease - No New York Heart Association class III or IV cardiac disease Other - No prior wound-healing disorders - No peptic ulcer disease within the past 6 months - No ongoing or active infection - No other concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance - No other malignancy within the past 5 years except for the following: - Adequately treated basal cell or squamous cell skin cancer - Carcinoma of the cervix - Adequately treated stage I or II cancer currently in complete remission - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 30 days after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - Prior interferon alfa in the adjuvant setting for resected stage III melanoma allowed - No prior antiangiogenic drugs - No more than 1 prior systemic biotherapy or biochemotherapy regimen for stage IV disease - Active vaccine therapy is not considered prior systemic therapy Chemotherapy - See Biologic therapy - No more than 1 prior systemic chemotherapy regimen for stage IV disease - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - Prior radiotherapy allowed provided there is objective evidence of disease progression for response assessment - More than 4 weeks since prior radiotherapy and recovered Surgery - See Disease Characteristics Other - Prior embolization or perfusion allowed provided there is objective evidence of disease progression for response assessment - No concurrent anticoagulant therapy (e.g., warfarin, heparin, or hirudin derivatives) - Concurrent low molecular weight heparin or other low-dose anticoagulants for flushing IV port devices or for thrombosis prophylaxis allowed - No other concurrent anticancer therapy - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KevinKim, Study Chair, M.D. Anderson Cancer Center
Additional Information:
Study ID Numbers: CDR0000360886; MDA-2003-0988,NCI-6387
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082875
Other Recurrent Melanoma Studies:
1. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
2. Biological Therapy in Treating Patients With Metastatic Melanoma
3. Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
4. Vaccine Therapy in Treating Patients With Stage IV Melanoma
5. PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
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Cilengitide in Treating Patients With Metastatic Melanoma
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