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Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma Clinical research trials and Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma. Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma  Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interferon alfa may interfere with the growth of the cancer cells and slow the growth of the tumor. Combining bevacizumab with interferon alfa may kill more tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of bevacizumab with or without interferon alfa in treating patients who have metastaticmalignantmelanoma.
Details: OBJECTIVES: - Compare the objective response rate and progression-free survival in patients with metastatic malignant melanoma treated with bevacizumab with or without interferon alfa. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive interferon alfa subcutaneously on days 1-14. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive bevacizumab as in arm I. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per arm) will be accrued for this study within 6-10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed cutaneous malignant melanoma - Must meet one of the following conditions: - Clinical evidence of metastatic disease - Unresectable regional lymphatic disease - Extensive in transit recurrent disease - Measurable disease - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No known brain metastases PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 6 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN - No clinical evidence of coagulopathy - PT INR less than 1.5 - PTT normal Renal: - Creatinine no greater than ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No history of thrombosis (e.g., deep vein thrombosis) - No uncontrolled hypertension Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to compounds of similar chemical or biologic composition to bevacizumab or interferon alfa - No ongoing or active infection - No other concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance - HIV allowed provided otherwise well PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior adjuvant interferon alfa - No prior interferon alfa for metastatic disease - No prior cytokine therapy for metastatic disease (e.g., high-dose interleukin-2) - No prior investigational antiangiogenic agents Chemotherapy: - No more than 1 prior chemotherapy regimen for metastatic disease - At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamCarson, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting William Carson 614-292-5819
Cincinnati Hematology-Oncology, Inc. *Recruiting*
Cincinnati, Ohio, 45209
United States
Recruiting Philip Leming 513-321-4333
Additional Information:
Study ID Numbers: CDR0000069010; NCI-2669,OSU-01H0185
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026221
Other Stage 4 Melanoma Studies:
1. Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
2. Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
3. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
4. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
5. Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
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