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Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma Clinical research trials and Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma. Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma clinical trial. Subjects often receive the most expert healthcare possible for their Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma  Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
For Condition: stage 3 melanoma,Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Virginia, Health Sciences Center Cancer Center
Synopsis: RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and interleukin-2 may be kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma.
Details: OBJECTIVES: I. Compare the effectiveness of vaccination with synthetic melanoma peptides pulsed on autologous dendritic cells versus vaccination with synthetic melanoma peptides plus sargramostim (GM-CSF) in decreasing tumor burden in patients with high risk melanoma (pulsed autologous dendritic cell arm closed 1/8/2001). II. Determine whether these regimens result in increased tumor specific immune responses as measured in vitro and in vivo. III. Determine whether these regimens stimulate T-cell responses in these patients. PROTOCOL OUTLINE: This is an open label study. Patients are included in treatment arm II only (arm I closed 1/8/2001): Arm I: Patients undergo leukapheresis to collect dendritic cells. Patients receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus peptides) pulsed on autologous dendritic cells IV and subcutaneously (SC). Arm II: Patients receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus peptides) and sargramostim (GM-CSF) emulsified in Montanide ISA-51 SC and intradermally. Patients receive vaccination during weeks 0, 1, 2, 4, 5, and 6 for a total of 6 doses and interleukin-2 SC daily on days 7-49. Patients receive 3 additional vaccinations at different sites not involved with the tumor concurrently with the first 3 vaccinations. Patients are evaluated at 8 weeks, 12 weeks, 6 months, 12 months, and 24 months. PROJECTED ACCRUAL: A total of 27-54 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/79 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed stage III or IV melanoma; gp100 positive tumor cells and/or tyrosinase positive tumor cells - HLA type A1, A2, or A3 - Measurable disease - May have up to 3 brain metastases if all are less than 2 cm in diameter and are asymptomatic, and there is no mass effect or they have been treated successfully by surgical excision or by gamma knife radiation therapy --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 months since prior growth factors; At least 3 months since prior agents with putative immunomodulating activity (except nonsteroidal antiinflammatory agents); At least 1 year since other prior melanoma vaccinations - Chemotherapy: At least 3 months since prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: At least 3 months since prior corticosteroids; No concurrent corticosteroids - Radiotherapy: At least 3 months since prior radiotherapy; No concurrent radiotherapy - Surgery: See Disease Characteristics - Other: At least 3 months since other prior investigational drugs or therapy; At least 3 months since prior allergy desensitization injections; At least 14 days since completion of acute treatment for a serious infection; No concurrent allergy desensitization injections --Patient Characteristics-- - Age: 18 to 79 - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 1,000/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 9 g/dL - Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN); AST and ALT no greater than 2.5 times ULN; Alkaline phosphatase no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No New York Heart Association class II, III, or IV heart disease - Other: No known or suspected allergy to any component of the vaccine; No medical condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CraigSlingluff, Study Chair, University of Virginia, Health Sciences Center Cancer Center
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Additional Information:
Study ID Numbers: CDR0000066084; UVACC-HIC-7621,NCI-G98-1389,UVA-HIC-7621
Study Start Date: April 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003222
Other Stage 4 Melanoma Studies:
1. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
2. Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
3. O6-benzylguanine and Carmustine in Treating Patients with Unresectable Locally Recurrent or Metastatic Melanoma
4. Vaccine Therapy in Treating Patients With Metastatic Melanoma
5. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Virginia Clinical Trials
Other Charlottesville Clinical Trials
Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
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