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Home > "V" Clinical Trials Conditions > Vaccine Plus Interleukin-2 Treatment of Metastatic Melanoma  Vaccine Plus Interleukin-2 Treatment of Metastatic Melanoma
Vaccine Plus Interleukin-2 Treatment of Metastatic Melanoma
For Condition: Melanoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the safety and effectiveness of treatment with an experimental vaccine plus interleukin-2 (IL-2) for melanoma, a type of cancer that arises from pigmented areas, usually of the skin. The experimental vaccine is composed of two viruses fowlpox (which does not cause disease in healthy adults), and vaccinia (which was previously used to vaccinate people against smallpox). A gene for tyrosinase, a protein commonly found in melanoma tumors, will be placed in each virus. The viruses deliver the protein into the body, where it can activate the cells of the immune system to fight the cancer. IL-2 is a substance naturally produced by the immune system that may boost the body's response to the vaccine. Patients 16 years of age and older with metastatic melanoma (melanoma that has spread beyond the original tumor site) that is not responding to standard treatment may be eligible for this study. Patients whose tumors originated in the eye or mucous membranes, who are allergic to eggs, or who are pregnant or breast-feeding may not participate. Candidates will be screened with physical, neurological, and eye examinations; blood and urine tests, chest x-ray, electrocardiogram (EKG), magnetic resonance imaging (MRI) and computed tomography (CT) scans to measure the size and extent of disease, and possibly a tumor biopsy (see below) to determine how much tyrosinase the tumor produces. Participants will undergo the following procedures and tests: - Vaccine injections: Patients will be given a shot of the vaccinia-tyrosinase vaccine, followed by two fowlpox-tyrosinase vaccines. All injections will be separated by 2 weeks. - Interleukin-2 treatments: After the last vaccine injection, patients will be admitted to the NIH Clinical Center to begin the first course of IL-2 treatment. One dose of drug will be infused through a vein every 8 hours for 4 days. Each infusion takes 15 minutes. During this time, blood will be drawn periodically for tests. About 10 days after discharge from the Clinical Center, patients will return for a second IL-2 treatment. - Apheresis: Patients will undergo apheresis, a procedure for collecting quantities of lymphocytes (white blood cells) before and after treatment. Blood is collected through a needle in an arm vein and circulated through a cell separator machine, where it is separated it into its components by centrifugation (spinning). The white cells are removed, and the rest of the blood (red cells, plasma and platelets) is returned to the body through another needle in the other arm. The cells will be examined for reactions against cancer cells. - Biopsies: A tumor biopsy may be done before starting treatment, and a tumor or lymph node biopsy may be done during or after treatment. A biopsy is the removal of a small piece of tissue, which is examined under the microscope to evaluate the effects of treatment. For the procedure, a mall area of skin is numbed and a piece of the tumor or lymph node is removed with a needle or by a small cut in the tumor. Biopsies are not required for participation in the study. - Post-treatment evaluation: Patients will return to the Clinical Center for a physical examination, x-rays or scans, and blood tests 1 month after receiving their last IL-2 treatment. Patients whose tumors continues to grow during treatment will be taken off the study. Those whose tumors respond to therapy may continue treatment unless they develop unacceptable side effects.
Details: Patients with metastatic melanoma will be immunized with recombinant vaccinia and fowlpox viruses encoding the melanoma associated antigen tyrosinase, following which they will be treated with a standard regimen of high dose IL-2. Patients will be eligible for this protocol regardless of HLA type, since tyrosinase contains multiple immunogenic peptides recognized by CD4+ and CD8+ T cells in the context of a variety of HLA alleles. The two poxviruses will be administered intramuscularly on a sequential schedule, one vaccinia followed by two fowlpox inoculations (heterologous prime/boost), designed to minimize immune reactions against viral proteins and maximize responses against the tyrosinase transgene. In this phase II therapy trial, patients will be evaluated for clinical as well as immunological responses. The observed clinical response rate will be compared to the historical CR+PR rate of 15% for melanoma patients treated with high dose IL-2 alone.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: a. Any patient age greater than or equal to 16 years with measurable metastatic melanoma whose disease has progressed while receiving standard treatment and who has an expected survival of greater than three months will be considered. b. Serum creatinine of 1.6 mg/dl or less. c. Total bilirubin 1.6 mg/dl or less, except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dl. d. WBC 3000/mm(3) or greater. e. Platelet count 90,000 mm(3) or greater. f. Serum AST/ALT less than three times normal. g. ECOG performance status of 0 or1. h. Patients of both genders must be willing to practice effective birth control during this trial. i. Patients must be able to avoid close contact with children less than 5 years of age, pregnant women, individuals with active or a past history of eczema or other eczematoid skin disorders, or those with other acute or chronic or exfoliative skin condtions (e.g. burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) and immunosuppressed individuals for two weeks after the vaccinia vaccination. EXCLUSION CRITERIA: Patients will be excluded: a. who are undergoing or have undergone in the past 3 weeks any form of systemic therapy for their cancer, or who have not recovered from any acute toxicity related to prior therapy, including surgery. b. who have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems. c. who require steroid therapy, including oral, intravenous, topical and inhaled steroids. d. who are pregnant or nursing (because of possible side effects on the fetus or neonate). e. who are known to be positive for hepatitis B(s)Ag, anti-HIV or anti-HIV antibody (because of possible immune effects of these conditions). f. who have any form of primary or secondary immunodeficiency. g. who are allergic to eggs. h. who have uncontrolled brain metastases. i. who have active atopic dermatitis or active or a past history of eczema, because of the risk of eczema vaccinatum. Patients with active cases of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns or other traumatic or pruritic skin conditions or open wounds should not be treated until the condition has resolved. Surgical scars must be healed. Note: Patients with healed surgical stomas (e.g., colostomy) will be eligible. j. who have been inoculated with recombinant vaccinia or fowlpox vaccines to treat melanoma, because of anticipated high serum titers of neutralizing anti-viral antibodies. k. who have been inoculated with the full length tyrosine protein as a treatment for melanoma, or a vector encoding the full length protein. However, patients inoculated with individual tyrosinase peptides will be eligible. l. whose primary site of melanomas was ocular or mucosal. m. who have previously received treatment with high dose IL-2.
Total Enrollment: 35
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030080; 03-C-0080
Study Start Date: January 10, 2003
Record last reviewed: April 21, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051610
Other Melanoma Studies:
1. CTLA-4 Antibody (MDX-010) Plus Interleukin-2 to Treat Advanced Melanoma
2. A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer
3. Vaccine Therapy and/or Sargramostim in Treating Patients With Locally Advanced or Metastatic Melanoma
4. gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
5. Study of Karenitecin (BNP1350) to treat Malignant Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Vaccine Plus Interleukin-2 Treatment of Metastatic Melanoma
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