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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00107159
First received: April 5, 2005
Last updated: November 5, 2013
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Immune response [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: January 2005
Study Completion Date: September 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107159

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Antoni Ribas, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00107159     History of Changes
Other Study ID Numbers: CDR0000422429, UCLA-0408080-01, IDM-DC-MEL-202
Study First Received: April 5, 2005
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 14, 2014