- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00012064
Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV or recurrent melanoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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California
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Newport Beach, California, United States, 92663
- Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biological/Vaccine
Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product. |
Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: treatment
|
treatment
|
To determine the frequency of conversion of delayed tumor hypersensitivity (DTH) tests with irradiated autologous tumor cells, in patients who received an autologous dendritic cell/tumor cell vaccine with GMCSF
Time Frame: treatment
|
treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the objective tumor response rate in patients with metastatic melanoma who still had measurable disease at the time vaccine treatment was given
Time Frame: follow-up
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follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Robert O. Dillman, MD, FACP, Hoag Memorial Hospital Presbyterian
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000068481
- HOAG-VACCINE-MEL
- NCI-V01-1646
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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Mayo ClinicNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
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