Melanoma (Skin) Clinical Trial
Official title:
Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma
RATIONALE: The LMB-2 immunotoxin can find tumor cells and kill them without harming normal
cells. Vaccines made from peptides may help the body build an effective immune response to
kill tumor cells. Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor
cells.
PURPOSE: This phase II trial is studying how well giving LMB-2 immunotoxin together with
vaccine therapy works in treating patients with metastatic melanoma that cannot be removed
by surgery.
Status | Completed |
Enrollment | 26 |
Est. completion date | July 2008 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of metastatic melanoma - Unresectable disease - Progressive disease while receiving standard therapy (e.g., interleukin-2 or dacarbazine) - HLA-A0201 positive - Measurable disease - The following are not allowed: - Resectable local/regional disease - Patients whose serum neutralizes LMB-2 in tissue culture, due either to antitoxin or antimouse-immunoglobulin G antibodies (> 75% of the activity of 1 ug/mL of LMB-2) - Received LMB-2 on another trial PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy more than 3 months - WBC = 3,000/mm^3 - Absolute lymphocyte count > 500/mm^3 - Platelet count = 90,000/mm^3 - Bilirubin = 2.0 mg/dL (= 3.0 mg/dL for patients with Gilbert's syndrome) - AST and ALT = 2.5 times normal - Albumin = 3.0 g/dL - No hepatitis B surface antigen or hepatitis C positivity - Creatinine = 1.4 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No ongoing or active infection - Ejection fraction = 45% by echocardiogram or thallium stress test (for patients > 50 years of age OR who have a history of cardiovascular disease) - LVEF = 45% - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No psychiatric illness or social situation that would preclude study compliance - No other uncontrolled illness - No known HIV positivity - No autoimmune disease - No immunodeficiency - No other malignancies - Must be willing to undergo leukapheresis PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 12 weeks since prior monoclonal antibody therapy - More than 3 weeks since prior and no concurrent systemic therapy for cancer - No concurrent chronic anticoagulant therapy - No concurrent systemic steroid therapy |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | NCI - Surgery Branch | Bethesda | Maryland |
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective clinical response rate | No | ||
Secondary | Changes in levels of CD4+, CD25+ regulatory T cells | No | ||
Secondary | Ability of LMB-2 to augment peptide vaccination | No | ||
Secondary | Toxicity | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04062032 -
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
|
Phase 2 | |
Completed |
NCT03620019 -
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT03291002 -
Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC
|
Phase 1 | |
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Completed |
NCT00962845 -
Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
|
Early Phase 1 | |
Completed |
NCT00324623 -
Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma
|
Phase 1 | |
Completed |
NCT00104845 -
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
|
Phase 1 | |
Completed |
NCT00096382 -
Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00072124 -
Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma
|
Phase 3 | |
Completed |
NCT00072085 -
Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00089193 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT00039234 -
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
|
Phase 3 | |
Completed |
NCT00049010 -
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
|
N/A | |
Completed |
NCT00042783 -
Vaccine Therapy in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
Completed |
NCT00005610 -
Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
|
Phase 2 | |
Completed |
NCT00006022 -
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|
Phase 1 | |
Completed |
NCT00006385 -
Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00020358 -
Vaccine Therapy in Treating Patients With Melanoma
|
Phase 2 | |
Recruiting |
NCT03767348 -
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
|
Phase 2 | |
Withdrawn |
NCT00006126 -
Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
|
Phase 1 |