Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma
This study is currently recruiting participants.
Verified June 2009 by National Cancer Institute (NCI)
Sponsor:
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00436930
First received: February 15, 2007
Last updated: September 27, 2011
Last verified: June 2009
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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 |
| Estimated Primary Completion Date: | December 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436930
Locations
| United States, California | |
| Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian | Recruiting |
| Newport Beach, California, United States, 92663 | |
| Contact: Clinical Trials Office - Hoag Cancer Institute 949-764-5543 | |
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: | September 27, 2011 |
| 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 May 19, 2013