Status:
COMPLETED
Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 contro...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00107159
Start Date
January 1 2005
End Date
September 1 2010
Last Update
November 6 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781