Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	Over 16	Other	HOAG-VACCINE-MEL NCI-V01-1646, NCT00012064

Objectives

1. 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.
2. Determine the frequency of conversion of delayed tumor hypersensitivity tests in patients treated with this regimen.
3. Determine the progression-free and overall survival in patients treated with this regimen.
4. Determine the objective tumor response rate in patients with measurable melanoma treated with this regimen.

Entry 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

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

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/mm³
• 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

Expected Enrollment

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

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.

Dillman RO, Schiltz PM, Selvan R, et al.: Patient-specific cancer vaccine of cultured autologous tumor cells and autologous dendritic cells. [Abstract] J Immunother 24 (5): S5, 2001.

Trial Contact Information

Trial Lead Organizations

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Robert Dillman, MD, FACP, Protocol chair		Ph: 949-764-8091 Email: rdillman@hoaghospital.org

Registry Information
Official Title		Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients with Metastatic Melanoma
Trial Start Date		2000-07-12
Registered in ClinicalTrials.gov		NCT00012064
Date Submitted to PDQ		2001-01-09
Information Last Verified		2005-05-04

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