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


Phase 2
16 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

event-free survival [death or disease progression]

Outcome Time Frame:

5.5 years after treatment initation

Safety Issue:

No

Principal Investigator

Robert O Dillman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hoag Memorial Hospital Presbyterian

Authority:

United States: Food and Drug Administration

Study ID:

NCT00012064

NCT ID:

NCT00948480

Start Date:

October 2000

Completion Date:

September 2007

Related Keywords:

  • Metastatic Melanoma
  • autologous tumor cell vaccine
  • metastatic melanoma
  • sargramostim (GM-CSF)
  • Melanoma

Name

Location

Hoag Memorial Hospital PresbyterianNewport Beach, California  92658