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| Sponsor: | Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00056134 |
Purpose
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. Biological therapies such as denileukin diftitox may be able to deliver cancer-killing substances directly to melanoma cells. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining vaccine therapy with denileukin diftitox in treating patients who have stage III or stage IV melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: denileukin diftitox Biological: recombinant CD40-ligand Biological: therapeutic autologous dendritic cells |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vaccination of HLA-A1 and/or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide-Loaded Autologous Dendritic Cells With Prior Depletion of CD25-Positive Cells Using Denileukin Difitox (ONTAK) |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2002 |
OBJECTIVES:
OUTLINE:
Patients who show a tumor response (at least stable disease) may receive vaccination #5 and further booster vaccinations.
Patients are followed for 10 years.
PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed locoregional or metastatic cutaneous malignant melanoma
Stage III or IV disease
HLA-A1 and/or HLA-A2 expression by serologic HLA typing
No active CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
No immunodeficiency disease
No active autoimmune disease including, but not limited to:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Germany | |
| Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen | |
| Erlangen, Germany, D-91052 | |
| Study Chair: | Gerold Schuler | Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen |
More Information
| ClinicalTrials.gov Identifier: | NCT00056134 History of Changes |
| Other Study ID Numbers: | CDR0000270762, ERLANGEN-ONTAK, EU-20246 |
| Study First Received: | March 6, 2003 |
| Last Updated: | November 29, 2011 |
| Health Authority: | United States: Federal Government |
|
recurrent melanoma stage IV melanoma stage IIIA melanoma stage IIIB melanoma stage IIIC melanoma |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Denileukin diftitox Interleukin-2 |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |