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Randomized Phase II Trial of Autologous Vaccines Consisting of Adjuvant GM-CSF Plus Proliferating Tumor Cells Versus GM-CSF Plus Dendritic Cells Loaded With Proliferating Tumor Cells in Patients With Metastatic Melanoma (MAC-VAC)


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

Thank you

Trial Information

Randomized Phase II Trial of Autologous Vaccines Consisting of Adjuvant GM-CSF Plus Proliferating Tumor Cells Versus GM-CSF Plus Dendritic Cells Loaded With Proliferating Tumor Cells in Patients With Metastatic Melanoma (MAC-VAC)


OBJECTIVES:

- Compare overall survival, progression-free survival, event-free survival, and
failure-free survival of patients with metastatic melanoma treated with vaccine therapy
comprising irradiated autologous tumor cells vs autologous dendritic cells loaded with
irradiated autologous tumor cells in combination with sargramostim (GM-CSF).

- Compare the frequency of immune response based on delayed-type hypersensitivity to
irradiated autologous tumor cells and serologic and cellular assays at baseline and
during and after completion of autologous tumor cell-based vaccine therapy in these
patients.

- Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to measurable disease
(yes vs no) and location of disease (distant vs regional). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive irradiated autologous tumor cells subcutaneously (SC) and
sargramostim (GM-CSF) SC once weekly for 3 weeks and then once monthly for up to 5
months in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive autologous dendritic cells loaded with irradiated autologous
tumor cells SC and GM-CSF SC once weekly for 3 weeks and then once monthly for up to 5
months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of melanoma

- Regionally recurrent or distant metastatic disease

- Must have an established continuously proliferating cell line expanded to about 200
million cells that is free of stromal cells and contamination

- No active CNS metastases

- Prior treatment for brain metastases or spinal cord compression allowed

- No clear evidence of disease progression in the CNS

- No concurrent pharmacologic doses of corticosteroids

PATIENT CHARACTERISTICS:

- Karnofsky performance status (PS) 70-100% OR ECOG PS 0-1

- Platelet count > 100,000/mm³

- Hematocrit > 30%

- Creatinine < 2.0 mg/dL

- Bilirubin < 2.0 mg/dL

- Albumin > 3.0 mg/dL

- No significant hepatic or renal dysfunction

- No other invasive cancer within the past 5 years

- No active infection or other active medical condition that could be eminently life
threatening, including any of the following:

- Active blood clotting

- Bleeding diathesis

- No ongoing transfusion requirement

- No underlying cardiac disease associated with known myocardial dysfunction

- No unstable angina related to atherosclerotic cardiovascular disease

- No known autoimmune disease

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

- Prior surgery, radiotherapy, chemotherapy, biological therapy (including sargramostim
[GM-CSF]), or vaccine therapy allowed

- No concurrent anticancer therapy (e.g., hormone therapy for prostate or breast
cancer)

- No concurrent digoxin or other medications for the treatment of heart failure

- No concurrent immunosuppressive therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival, progression-free survival, event-free survival, and failure-free survival

Safety Issue:

No

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian

Authority:

Unspecified

Study ID:

CDR0000530026

NCT ID:

NCT00436930

Start Date:

December 2006

Completion Date:

Related Keywords:

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

Name

Location

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