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Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma Clinical research trials and Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma. Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma clinical trial. Human subjects often obtain the finest healthcare possible for their Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma  Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma,stage 3 melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Albert Einstein Cancer Research Center
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma. II. Determine all clinical toxicities associated with this regimen in this patient population. III. Determine the safety of this regimen in this patient population. IV. Assess evidence of host antimelanoma immune reactivity following this regimen. V. Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response in this patient population receiving this regimen. VII. Evaluate quality of life of these patients during this regimen. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities. Quality of life is assessed before treatment, every 4 weeks, and at end of treatment. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study over 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven metastatic, unresectable melanoma; Dermal, subcutaneous, or lymph node metastases; Accessible for injection; Lesions must measure at least 1 cm - Patients with no prior treatment allowed - Patients must have one of the following as proof of prior vaccinia immunization: Physician certification; Recollection and appropriate vaccination scar site - No encephalitis, untreated cerebral metastases, other structural brain lesions, or leptomeningeal disease - No ascites or pleural effusions - No leukemia or lymphoma --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; At least 8 weeks since prior immunotherapy and recovered; No prior live pox virus vector - Chemotherapy: No more than 2 prior chemotherapy regimens; At least 4 weeks since prior chemotherapy and recovered - Endocrine therapy: At least 4 weeks since prior systemic corticosteroids; No systemic corticosteroids for concurrent illness; No concurrent immunosuppressive steroids - Radiotherapy: At least 2 weeks since prior radiotherapy and recovered (no bone marrow toxicity); At least 6 months since prior radiotherapy for brain metastases and recovered - Surgery: At least 4 weeks since prior surgery for management of the primary or metastatic lesions and recovered with remaining measurable disease; At least 6 months since prior surgery for brain metastases and recovered - Other: No concurrent immunosuppressive drugs --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-1; Karnofsky 80-100% - Life expectancy: Greater than 3 months - Hematopoietic: WBC greater than 4,000/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 10g/dL - Hepatic: Bilirubin less than 1.5 mg/dL; Transaminases no greater than 2 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2 times ULN; PT/PTT no greater than 2 fold elevation in patients not receiving anticoagulation medications; No alcoholic cirrhosis - Renal: Creatinine less than 2.0 mg/dL OR Creatine clearance greater than 60 mL/min - Cardiovascular: No congestive heart failure; No serious cardiac arrhythmias; No recent prior myocardial infarction; No clinical coronary artery disease - Pulmonary: No chronic obstructive pulmonary disease - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No seizure disorders; No underlying immunosuppressive disorder; No autoimmune disease; HIV negative; No skin diseases; No open wounds; No eczema or other contraindications to vaccinia virus administration; Patients must be able to avoid high risk individuals (e.g., immunosuppressed patients, children under 3 years, pregnant women, patients with active or a history of eczema, or patients with other skin conditions) for 7-10 days following treatment; No significant allergy or hypersensitivity to eggs; No active or chronic infections; No concurrent medical illness; No other significant medical disease which would increase risk to patient; No other prior malignancy within the past 5 years except stage I carcinoma of the cervix or basal cell carcinoma
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardKaufman, Study Chair, Albert Einstein Cancer Research Center
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Additional Information:
Study ID Numbers: CDR0000067380; AECM-99-101,NCI-T99-0006
Study Start Date: October 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004148
Other Recurrent Melanoma Studies:
1. CCI-779 in Treating Patients With Metastatic Melanoma
2. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
3. Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
4. Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
5. Imatinib Mesylate in Treating Patients With Metastatic Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
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