Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436930
• Other study ID #: CDR0000530026
• Secondary ID: HOAG-HCC-06-03
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2007
• Last updated: January 9, 2014
• Start date: December 2006
• Est. completion date: October 2012

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for melanoma.

PURPOSE: This randomized phase II trial is studying two different vaccine therapy regimens to compare how well they work when given together with GM-CSF in treating patients with recurrent or metastatic melanoma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• autologous tumor cell vaccine
Given subcutaneously
• sargramostim
Given subcutaneously
• therapeutic autologous dendritic cells
Given subcutaneously

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoag Memorial Hospital Presbyterian

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival, progression-free survival, event-free survival, and failure-free survival			No
Primary	Frequency of immune response as measured by delayed-type hypersensitivity and serologic and cellular assays at baseline and during and after completion of study treatment			No
Primary	Safety			Yes