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Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma


Phase 1/Phase 2
16 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma


OBJECTIVES:

- Determine the safety of immunization with autologous in vitro-treated tumor cells and
dendritic cells in combination with sargramostim (GM-CSF) in patients with stage IV or
recurrent melanoma.

- Determine the frequency of conversion of delayed tumor hypersensitivity tests in
patients treated with this regimen.

- Determine the progression-free and overall survival in patients treated with this
regimen.

- Determine the objective tumor response rate in patients with measurable melanoma
treated with this regimen.

OUTLINE: Patients are stratified according to presence of measurable disease at study
initiation (yes vs no).

Patients undergo tumor cell harvest. Patients with multiple persistent sites of metastatic
disease after harvest may receive systemic therapy (biologic therapy and/or chemotherapy)
during tumor cell line expansion over approximately 4 months. The tumor cell line is
expanded, irradiated, and treated with interferon gamma.

Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC) to
obtain dendritic cells (DC). The PBMC are treated with sargramostim (GM-CSF) and
interleukin-4 for 7 days to produce DC. The DC are then cultured with the treated tumor
cells for 18 hours.

Patients undergo delayed tumor hypersensitivity tests intradermally 1 week prior to
vaccination and again at week 4. Patients receive vaccine therapy comprising autologous
treated tumor cells and dendritic cells suspended in GM-CSF subcutaneously weekly for 3
weeks. Vaccine therapy continues monthly for an additional 5 months in the absence of
disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year and then every 3 months for 4 years.

PROJECTED ACCRUAL: A total of 30-80 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV or recurrent melanoma

- Metastatic disease confirmed by MRI or CT scan

- Planned resection of tumor

- No active CNS metastases

- Radiographically confirmed lack of CNS disease progression

- No requirement for pharmacologic doses of corticosteroids

PATIENT CHARACTERISTICS:

Age:

- Over 16

Performance status:

- ECOG 0-2

Life expectancy:

- At least 4 months

Hematopoietic:

- Hematocrit greater than 25%

- Platelet count greater than 100,000/mm^3

- No ongoing transfusion requirements

- No active blood clotting or bleeding diathesis

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- Albumin at least 3.0 g/dL

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No underlying cardiac disease associated with known myocardial dysfunction

- No unstable angina related to atherosclerotic cardiovascular disease

Other:

- No other malignancy within the past 5 years except for carcinoma in situ, basal cell
carcinoma, or localized squamous cell skin cancer

- No active, eminently life-threatening infection or medical condition

- Adequate venous access

- Not pregnant

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Other prior putative vaccines allowed

- Recovered from prior biologic therapy

- No other concurrent biologic therapy except epoetin alfa for patients with hematocrit
less than 36%

Chemotherapy:

- At least 3 weeks since prior chemotherapy and recovered

- No concurrent chemotherapy

Endocrine therapy:

- See Disease Characteristics

- No concurrent endocrine therapy

Radiotherapy:

- At least 3 weeks since prior radiotherapy (including whole brain radiotherapy) and
recovered

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- Recovered from prior surgery

Other:

- Concurrent bisphosphonates allowed for patients with lytic bone metastases

- No concurrent digoxin or other medications designed to improve cardiac output

- No other concurrent investigational therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF

Outcome Time Frame:

treatment

Safety Issue:

Yes

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Hoag Memorial Hospital Presbyterian

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068481

NCT ID:

NCT00012064

Start Date:

July 2000

Completion Date:

April 2011

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Hoag Cancer Center at Hoag Memorial Hospital PresbyterianNewport Beach, California  92663