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

NCT00107159 | Completed Phase 2

• 3 other identifiers: CDR0000422429UCLA-0408080-01IDM-DC-MEL-202
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage III melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• Safety

• Immune response

Interventions

autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

• 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.

  PMID: 20875102 RESULT

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Antoni Ribas, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: January 1, 2005
• Study Completion: September 1, 2010
• Last Updated: November 6, 2013

Record last verified: 2007-04

Locations

US (1)