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Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma Clinical research trials and Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma health trials happen in many 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 measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma. Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma clinical trial. Human subjects often get the best healthcare available for their Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma  Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Recruiting
Sponsor(s): Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen ,
Synopsis: RATIONALE: Vaccines made from a person's dendritic cells and antigens may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IVcutaneousmelanoma.
Details: OBJECTIVES: Primary - Determine the safety and tolerability of vaccination with autologous monocyte-derived dendritic cells (DC) transfected with RNAs encoding Melan-A, MAGE-3, and survivin antigens in patients with stage IV cutaneous melanoma. - Determine whether tumor antigen-specific T-cell responses are induced in patients treated with this vaccine. - Determine whether simultaneous loading of DC with keyhole limpet hemocyanin (KLH) significantly enhances induction of the Melan-A, MAGE-3, and survivin antigens in these patients. Secondary - Determine clinical antitumor activity (e.g., objective tumor response, time to tumor progression, progression-free interval, and overall survival) in patients treated with this vaccine. OUTLINE: This is an open-label, nonrandomized study. - Beginning 9-11 days before vaccination, patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs). PBMCs are processed for the generation of dendritic cells (DC) to be used for vaccinations. PBMCs are transfected with RNAs encoding for Melan-A, MAGE-3, and survivin antigens. DC are pulsed with keyhole limpet hemocyanin (KLH) for some patients. Patients receive antigen-pulsed (with or without KLH) DC vaccination subcutaneously (SC) on days 1, 15, 43, and 71 in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may proceed to the phase II portion of the study. - Phase II: Patients undergo leukapheresis as in phase I on days 102, 354, and 690. Patients receive up to 6 additional booster vaccinations SC as in phase I on days 127, 185, 269, 356, 521, and 692. Patients are followed for 10 years. PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed cutaneous* melanoma - Stage IV - Incurable by surgical resection - Progressive disease after at least 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy) - Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or noninvasive radiological procedures - No active CNS metastases by CT scan or MRI - Previously treated (e.g., excision of a single metastasis) CNS metastases are allowed provided there are no signs of active CNS metastases NOTE: *Metastatic melanoma with unidentified primary tumor allowed provided an ocular melanoma can be definitely excluded and origin from the skin is likely PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - At least 4 months Hematopoietic - WBC greater than 2,500/mm^3 - Neutrophil count greater than 1,000/mm^3 - Lymphocyte count greater than 700/mm^3 - Platelet count greater than 75,000/mm^3 - Hemoglobin greater than 9 g/dL - No bleeding disorder Hepatic - Bilirubin less than 2.0 mg/dL - No evidence of hepatitis B or C infection Renal - Creatinine less than 2.5 mg/dL Cardiovascular - No clinically significant heart disease Pulmonary - No respiratory disease Immunologic - HIV-1 and HIV-2 negative - HTLV-1 negative - No active systemic infection - No immunodeficiency disease - No active autoimmune disease (e.g., lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, or inflammatory bowel disease) - Vitiligo allowed Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 4 weeks after study participation - Stable medical condition - No other major serious illness - No contraindication to leukapheresis - No organic brain syndrome or significant psychiatric abnormality that would preclude study participation or follow-up - No other active malignant neoplasm PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior immunotherapy - No other concurrent immunotherapy during and for 2 weeks after study participation Chemotherapy - More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas [e.g., fotemustine]) - No concurrent chemotherapy during and for 2 weeks after study participation Endocrine therapy - No concurrent corticosteroids during and for 2 weeks after study participation Radiotherapy - More than 2 weeks since prior radiotherapy - No prior radiotherapy to the spleen - Concurrent palliative radiotherapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed Surgery - Recovered from prior surgery - No prior splenectomy - No prior organ allografts - Concurrent surgical therapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed - Selected accessible metastases may be removed for tumor infiltrating lymphocyte assay or other immunomonitoring investigations (e.g., expression of tumor antigens and HLA molecules) Other - No other concurrent investigational drug or paramedical substance during and for 2 weeks after study participation - No concurrent participation in another clinical trial - Concurrent palliative medication allowed (e.g., acetaminophen, indomethacin, or opiates)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeroldSchuler, Principal Investigator, Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen
Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen *Recruiting*
Erlangen, , D-91052
Germany
Recruiting Gerold Schuler 49-9131-85-33164
Additional Information:
Study ID Numbers: CDR0000343699; ERLANGEN-DERMA-ER-DC-06,EU-20317
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074230
Other Recurrent Melanoma Studies:
1. Combination Chemotherapy With or Without Interleukin-2 and Interferon alfa in Treating Patients With Metastatic Melanoma
2. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
3. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
4. Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
5. Vaccine Therapy and Interleukin-12 in Treating Patients With Metastatic Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Clinical Trials
Other Erlangen Clinical Trials
Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
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