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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00436930
First received: February 15, 2007
Last updated: January 9, 2014
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: autologous tumor cell vaccine
Biological: sargramostim
Biological: therapeutic autologous dendritic cells
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival, progression-free survival, event-free survival, and failure-free survival [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: December 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: autologous tumor cell vaccine
Given subcutaneously
Biological: sargramostim
Given subcutaneously
Experimental: 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.
Biological: sargramostim
Given subcutaneously
Biological: therapeutic autologous dendritic cells
Given subcutaneously

Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436930

Locations
United States, California
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Sponsors and Collaborators
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Investigators
Study Chair: Robert O. Dillman, MD, FACP Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert O. Dillman, Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier: NCT00436930     History of Changes
Other Study ID Numbers: CDR0000530026, HOAG-HCC-06-03
Study First Received: February 15, 2007
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 28, 2014