| ID | Type | Description | Link |
|---|---|---|---|
| 06-C-0041 | |||
| NCI-7542 | |||
| NCI-P6702 | |||
| CDR0000462165 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive LMB-2 immunotoxin IV over 30 minutes twice on days 1-3. Patients then receive peptide vaccinations comprising gp100:209-217 (210M) antigen emulsified in Montanide ISA-51 subcutaneously (SC), and MART-1:27-35 vaccine emulsified in Montanide ISA-51 SC on days 4, 5, 6, and 24-27 (course 1). After week 8, patients achieving tumor response may receive 1 additional course in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically in the absence of disease progression.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMB-2 immunotoxin | Biological | |||
| MART-1 antigen | Biological | |||
| gp100 antigen | Biological | |||
| incomplete Freund's adjuvant | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Objective clinical response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in levels of CD4+, CD25+ regulatory T cells | ||
| Ability of LMB-2 to augment peptide vaccination | ||
| Toxicity |
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DISEASE CHARACTERISTICS:
Diagnosis of metastatic melanoma
HLA-A0201 positive
Measurable disease
The following are not allowed:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland | 20892-1182 | United States | ||
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| NCI - Surgery Branch |
| Bethesda |
| Maryland |
| 20892-1201 |
| United States |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C077707 | B3(Fv)-PE38KDEL recombinant immunotoxin |
| D058965 | MART-1 Antigen |
| C114843 | incomplete Freund's adjuvant |
| ID | Term |
|---|---|
| D058950 | Melanoma-Specific Antigens |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
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