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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cutaneous Melanoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Antoni Ribas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000422429

NCT ID:

NCT00107159

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Cutaneous Melanoma
  • recurrent melanoma
  • stage III melanoma
  • stage IV melanoma
  • Melanoma
  • Skin Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781