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Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma Clinical research trials and Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma. Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma clinical trial. Human subjects often get the best healthcare possible for their Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma  Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
For Condition: Recurrent Melanoma,Stage 4 Melanoma,stage 3 melanoma
Status: Recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells. PURPOSE: Randomizedphase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastaticmelanoma.
Details: OBJECTIVES: - Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in patients with high-risk or metastatic melanoma. - Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens. - Compare tumor response in patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b combined and injected at one site, and MAGE-10.A2 injected at another site, intradermally once weekly on weeks 1-6. - Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim (GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days. Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for 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 high-risk stage III or IV melanoma - Stage III disease less than 6 months after surgical resection - Completed prior interferon alfa therapy OR - Progressive disease or major adverse events during prior interferon alfa therapy - Stage III disease at least 6 months after surgical resection - Declined, failed, or completed prior standard therapy - Stage IV disease - Declined, failed, or completed prior standard therapy - HLA-A2 positive - No CNS metastases unless treated and stable PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 80-100% Life expectancy: - At least 4 months Hematopoietic: - Neutrophil count at least 1,500/mm3 - Lymphocyte count at least 500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg) - No bleeding disorder Hepatic: - Bilirubin no greater than 2.0 mg/dL - No hepatitis B or C positivity Renal: - Creatinine no greater than 1.8 mg/dL Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - HIV negative - No other serious illness - No serious infection requiring antibiotics - No history of immunodeficiency disease or autoimmune disease - No psychiatric or addictive disorder that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior bone marrow or stem cell transplantation - At least 4 weeks since prior immunotherapy or biologic therapy - No other concurrent immunotherapy or biologic therapy Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No concurrent chemotherapy Endocrine therapy: - No concurrent systemic corticosteroids - No concurrent steroids except topical or inhalational steroids - Concurrent hormonal therapy allowed Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics - At least 4 weeks since prior surgery Other: - At least 4 weeks since prior investigational agents - Concurrent noncytotoxic anticancer therapy allowed - No concurrent immunosuppressive therapy - No concurrent antihistamines - No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KyriakosPapadopoulos, Study Chair, Columbia University
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Kyriakos Papadopoulos 212-305-9327
Additional Information:
Study ID Numbers: CDR0000069357; CPMC-IRB-13824,NCI-G02-2068,LUDWIG-LUD00-025
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037037
Other Stage 4 Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Metastatic Melanoma
2. Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301
3. Gene Therapy in Treating Patients With Metastatic Melanoma
4. Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma
5. PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
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