|
Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma Clinical research trials and Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma. Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma clinical trial. Test subjects typically obtain the finest healthcare available for their Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma  Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor. Interleukin-2 and interleukin-12 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy and interleukin-12 with interleukin-2 may be a more effective treatment for metastatic melanoma. PURPOSE: Randomizedphase II trial to study the effectiveness of vaccine therapy and interleukin-12 with or without interleukin-2 in treating patients who have metastatic melanoma.
Details: OBJECTIVES: - Compare peptide-interferon-gamma production by CD8+ T cells in patients with metastatic melanoma immunized with MAGE-3, Melan-A, gp100 antigen, and NA17-A peptide-pulsed autologous peripheral blood mononuclear cells and interleukin-12 with or without low-dose interleukin-2. - Compare the clinical response rate (complete and partial 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 immunization comprising MAGE-3, Melan-A, gp100 antigen, and NA17-A peptide-pulsed autologous peripheral blood mononuclear cells subcutaneously (SC) on day 1 and interleukin-12 (IL-12) SC on days 1, 3, and 5. - Arm II: Patients receive immunization and IL-12 as in arm I and low-dose interleukin-2 SC on days 7-18. Treatment in both arms repeats every 21 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response or stable disease may receive additional treatment sets of 3 courses for up to a total of 9 courses. Patients are followed every 8 weeks until disease progression and then at least every 3 months thereafter. PROJECTED ACCRUAL: A total of 36 patients (18 per treatment arm) will be accrued for this study within 1.25 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed melanoma - Evidence of metastatic disease by radiological or physical examination - In-transit metastases allowed - HLA-A2 positive - No untreated brain metastases - Brain lesions successfully treated by stereotactic radiotherapy or surgery with no recurrence at 28-day follow-up are allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Hemoglobin at least 9 g/dL - Platelet count at least 100,000/mm^3 Hepatic - SGPT no greater than 2 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 times ULN - Lactic dehydrogenase less than 1.25 times ULN - Hepatitis B and C negative Renal - Creatinine no greater than 1.5 times ULN - Calcium no greater than 11 mg/dL Cardiovascular - No significant cardiovascular disease - No cardiac arrhythmia requiring medical intervention Immunologic - HIV negative - No intrinsic immunosuppression - No serious concurrent infection, including active tuberculosis - No prior or active autoimmune disease including: - Rheumatoid arthritis (rheumatoid factor-positive with current or recent flare) - Inflammatory bowel disease - Systemic lupus erythematosus - Clinical evidence and antibody titer at least 1:80 - Ankylosing spondylitis - Scleroderma - Multiple sclerosis - Autoimmune hemolytic anemia - Immune thrombocytopenic purpura Other - Not pregnant or nursing - Negative pregnancy test - No psychiatric illness that would preclude study compliance or giving informed consent - No active gastrointestinal bleeding - No uncontrolled peptic ulcer disease PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy - No prior melanoma vaccine therapy containing the same MAGE-3, Melan-A, gp100 antigen, or NA17 peptides used in the study Chemotherapy - Prior chemotherapy allowed Endocrine therapy - No concurrent systemic corticosteroids except physiologic replacement doses Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics Other - No concurrent immunosuppressive drugs (e.g., cyclosporine)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasGajewski, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Thomas Gajewski 773-702-4601
Additional Information:
Study ID Numbers: CDR0000309519; UCCRC-11447A,NCI-1330
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064168
Other Recurrent Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Metastatic Melanoma
2. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
3. Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
4. Boron Neutron Capture Therapy in Treating Patients With Melanoma
5. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Vaccine Therapy and Interleukin-12 With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
|
|
|
|
|
|
|
|
