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

November 5, 2013 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Safety
Immune response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Antoni Ribas, MD, Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 5, 2005

First Submitted That Met QC Criteria

April 5, 2005

First Posted (Estimate)

April 6, 2005

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000422429
  • UCLA-0408080-01
  • IDM-DC-MEL-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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