Vaccine Biotherapy of Cancer: Autologous Tumor Cells and Dendritic Cells

Metastatic Melanoma Clinical Trial

— DCVaccineMel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948480
• Other study ID #: DC Melanoma
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2009
• Last updated: July 13, 2016
• Start date: October 2000
• Est. completion date: September 2007

Study information

• Verified date: July 2016
• Source: Hoag Memorial Hospital Presbyterian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This protocol was conducted as a single institution trial at Hoag Cancer Center, Hoag Hospital, Newport Beach, California. It was a single-arm phase II trial in which patients with metastatic melanoma received subcutaneous (s.c.) injections of irradiated autologous tumor cells that had been established as short-term cell lines, in conjunction with their own dendritic cells (DC) and granulocyte macrophage colony-stimulating factor [GM-CSF]. Eligible patients had regionally recurrent and/or distant metastatic cancer.

Description:

Patients were stratified by whether they had no measurable disease [NMD] at the time of treatment (usually because of surgical resection of metastases), or whether they had objectively measurable disease (OMD) by physical examination or radiologic scans per response evaluation criteria in solid tumors (RECIST criteria). Key endpoints were the results of delayed type hypersensitivity (DTH) skin testing to their own irradiated tumor cells, event-free survival [death or disease progression], overall survival, and objective tumor regression in patients who have measurable disease at the time vaccine therapy was initiated. This study was activated in the fall of 2000, and closed to accrual in June 2007.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Recurrent or metastatic melanoma as defined by stage IV disease (distant metastases), or any recurrent melanoma manifested by lymph node metastases or soft tissue nodules

• ECOG Performance status of 0-2

• Satisfactory medical condition for treatment in a phase I-II trial of anticancer therapy

• Age > 16 years

• Venous access for leukopheresis procedure to obtain peripheral blood lymphocytes to generate dendritic cells.

• Serum pregnancy test must be negative for women of childbearing potential.

Exclusion Criteria:

• Active central nervous system metastases

• Known autoimmune disease or disease process that involves the use of immunosuppressive therapy.

• Underlying cardiac disease associated with New York Heart Association class III or IV function, or unstable angina related to atherosclerotic cardiovascular disease.

• Ongoing transfusion requirements, no significant hepatic or renal dysfunction, creatinine < 2.0 mg/dl, bilirubin < 2.0 mg/dl, albumin > 3.0 mg/dl, hematocrit > 25, platelets > 100,000.

• Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis.

Study Design

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Biological:
• Autologous tumor cells plus dendritic cells
A series of 8 vaccinations are administered over 6 months

Drug:
• GM-CSF
500 mcg

Locations

Country	Name	City	State
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoag Memorial Hospital Presbyterian

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dillman RO, Selvan SR, Schiltz PM, McClay EF, Barth NM, DePriest C, de Leon C, Mayorga C, Cornforth AN, Allen K. Phase II trial of dendritic cells loaded with antigens from self-renewing, proliferating autologous tumor cells as patient-specific antitumor — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	event-free survival [death or disease progression]		5.5 years after treatment initation	No
Secondary	Overall survival		5.5 years after treatment initation	No