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Home > "V" Clinical Trials Conditions > Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma  Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
For Condition: Recurrent Melanoma,Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): University of Illinois , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic melanoma.
Details: OBJECTIVES: - Define the antitumor activity of gp100:209-217 (210M), a melanoma peptide derived from gp100 mixed with Montanide ISA-51, in combination with high-dose interleukin-2 (IL-2) administered by various schedules in patients with advanced melanoma. - Examine the effect of the addition of gp100:209-217 (210M) peptide vaccine to high-dose IL-2 on the toxicity of the treatment in these patients. - Define the induction of T-cell responses to gp100:209-217 (210M) peptide and its gp100 (parent) protein by ELISA with interferon gamma production or CTL precursor frequencies in these patients after the initial course of treatment. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (adjuvant interferon vs chemotherapy for advanced disease vs both vs none), ECOG performance status (0 vs 1), and number of organ sites involved (1 vs more than 1). Patients are randomized into 1 of 3 treatment arms. (Arm III closed to accrual as of 11/30/1998.) - Arm I: Patients receive vaccination comprising gp100:209-217 (210M) peptide mixed with Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Patients also receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours on days 2-6 and 16-20. - Arm II: Patients receive vaccination as in arm I on days 1, 22, 43, and 64. Patients also receive high-dose IL-2 as in arm I on days 44-48 and 60-64. Patients who demonstrate rapid visible disease progression during the initial 4 weeks of therapy while maintaining good performance status may begin high-dose IL-2 on day 23. - Arm III (closed to accrual as of 11/30/1998): Patients receive vaccination as in arm I on day 1 and then high-dose IL-2 as in arm I on day 2. Patients with nonhematologic toxicity may only receive vaccination on weeks 4, 7, and 10. Other patients may also receive IL-2 beginning on day 2 of each treatment week (4, 7, and 10) for up to 14 doses. Patients in each arm may receive up to a total of 3 courses of treatment. Patients are followed until death. PROJECTED ACCRUAL: Approximately 90 patients (25 patients for arms I and II and 40 patients for arm III [arm III closed to accrual as of 11/30/1998]) will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed clearly progressive metastatic or unresectable melanoma - Must be HLA-A2.1 positive - Measurable disease - No active brain metastases, leptomeningeal disease, or seizure disorder - More than 4 months since prior definitive therapy (surgery or radiotherapy) for brain metastases and must not have evidence of disease on brain CT scan or MRI - No ascites or pleural effusions PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 OR - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No congestive heart failure - No symptoms of coronary artery disease - No serious cardiac arrhythmias - No evidence of prior myocardial infarction on EKG - Normal cardiac stress test required for all patients over 40 years Pulmonary: - FEV_1 greater than 2.0 liters or at least 75% of predicted - No chronic obstructive pulmonary disease Other: - HIV negative - No significant systemic infection - No contraindication to use of pressor agents - No history of major psychiatric illness - No other major illness that would significantly increase the risk of immunotherapy - No other active malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ or stage I carcinoma of the cervix - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior interleukin-2 - At least 4 weeks since prior vaccine therapy or other cytokine therapy Chemotherapy: - One prior chemotherapy regimen allowed - At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and recovered Endocrine therapy: - No concurrent steroids Radiotherapy: - See Disease Characteristics - No prior radiotherapy to areas of measurable disease unless there has been clearly progressive disease in this site or there is measurable disease outside of areas of prior radiation - At least 2 weeks since prior radiotherapy for local control or palliative therapy and recovered Surgery: - See Disease Characteristics - Recovered from prior major surgery - No prior organ allografts Other: - No antihypertensive therapy within 24 hours prior to interleukin-2
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidGustin, Study Chair, University of Illinois
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-0269
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Comprehensive Cancer Center at Our Lady of Mercy Medical CenterOur
Bronx, New York, 10466
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2516
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15236
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Additional Information:
Study ID Numbers: CDR0000066634; CWG-UIC-T98-0027,NCI-T98-0027
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003568
Other Stage 4 Melanoma Studies:
1. Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
2. Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
3. Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
4. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
5. E7070 in Treating Patients With Stage IV Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
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