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Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed primary cutaneous or unknown primary melanoma, including 1 of the following stages: Stage IIIB or IIIC disease Unresected, in-transit lymph node metastases (N2c or N3) Stage IV disease Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b) No cerebral, bone, or other visceral metastases At least 1 measurable or evaluable lesion Small-volume multiple cutaneous deposits allowed Progressive disease, as defined by 1 of the following criteria: At least 20% increase in size in ≥ 1 measurable or evaluable lesion Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 6 months Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10.0 g/dL (transfusion allowed) Hepatic SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) Lactic dehydrogenase normal No active hepatitis B or C infection Renal Creatinine ≤ 1.5 times ULN Immunologic No history of autoimmune disease Vitiligo allowed No history of immunodeficiency syndrome No active bacterial, viral, or fungal infection within the past 72 hours HIV-1 or -2 negative Human T-cell lymphotrophic virus-I or -II negative Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No contraindication to apheresis No other significant medical or surgical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No prior vaccine therapy with ≥ 1 melanoma antigen or peptide More than 4 weeks since prior biologic therapy Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy No concurrent chronic systemic corticosteroids Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 4 weeks since prior investigational products More than 4 weeks since prior chronic systemic immunosuppressive treatment No concurrent medication or treatment regimen that would prelude study participation No other concurrent anticancer treatment No other concurrent immunosuppressive treatment

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Outcomes

Primary Outcome Measures

Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks

Secondary Outcome Measures

Safety
Immune response

Full Information

First Posted
April 5, 2005
Last Updated
November 5, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00107159
Brief Title
Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma
Official Title
A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma.
Detailed Description
OBJECTIVES: Primary Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates (IDD-3), as measured by tumor control, in patients with unresected stage IIIB or IIIC or stage IV melanoma. Secondary Determine the immunologic activity of this vaccine, as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides, in these patients. Determine the safety of this vaccine, as measured by the incidence and severity of adverse events, in these patients. OUTLINE: This is an open-label, multicenter study. Patients undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). The PBMCs are cultured with sargramostim (GM-CSF) and interleukin-13 for the production of dendritic cells. The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor cell lines (IDD-3) to produce the vaccine. Patients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5 intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks 0, 2, 4, 6, 8, 10, 16, and 22 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 2, 10, 18, and 26 weeks. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage III melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine
Primary Outcome Measure Information:
Title
Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
Secondary Outcome Measure Information:
Title
Safety
Title
Immune response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary cutaneous or unknown primary melanoma, including 1 of the following stages: Stage IIIB or IIIC disease Unresected, in-transit lymph node metastases (N2c or N3) Stage IV disease Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b) No cerebral, bone, or other visceral metastases At least 1 measurable or evaluable lesion Small-volume multiple cutaneous deposits allowed Progressive disease, as defined by 1 of the following criteria: At least 20% increase in size in ≥ 1 measurable or evaluable lesion Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 6 months Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10.0 g/dL (transfusion allowed) Hepatic SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) Lactic dehydrogenase normal No active hepatitis B or C infection Renal Creatinine ≤ 1.5 times ULN Immunologic No history of autoimmune disease Vitiligo allowed No history of immunodeficiency syndrome No active bacterial, viral, or fungal infection within the past 72 hours HIV-1 or -2 negative Human T-cell lymphotrophic virus-I or -II negative Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No contraindication to apheresis No other significant medical or surgical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No prior vaccine therapy with ≥ 1 melanoma antigen or peptide More than 4 weeks since prior biologic therapy Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy No concurrent chronic systemic corticosteroids Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 4 weeks since prior investigational products More than 4 weeks since prior chronic systemic immunosuppressive treatment No concurrent medication or treatment regimen that would prelude study participation No other concurrent anticancer treatment No other concurrent immunosuppressive treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Ribas, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20875102
Citation
Ribas A, Camacho LH, Lee SM, Hersh EM, Brown CK, Richards JM, Rodriguez MJ, Prieto VG, Glaspy JA, Oseguera DK, Hernandez J, Villanueva A, Chmielowski B, Mitsky P, Bercovici N, Wasserman E, Landais D, Ross MI. Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma. J Transl Med. 2010 Sep 27;8:89. doi: 10.1186/1479-5876-8-89.
Results Reference
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Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma

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