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

Primary Purpose

Melanoma (Skin)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

autologous tumor cell vaccine

sargramostim

therapeutic autologous dendritic cells

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I

Arm II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

Safety

Secondary Outcome Measures

Full Information

NCT ID

NCT00436930

First Posted

February 15, 2007

Last Updated

January 9, 2014

Sponsor

Hoag Memorial Hospital Presbyterian

1. Study Identification

Unique Protocol Identification Number

NCT00436930

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hoag Memorial Hospital Presbyterian

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

Keywords

recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Arm Title

Arm II

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

autologous tumor cell vaccine

Intervention Description

Given subcutaneously

Intervention Type

Biological

Intervention Name(s)

sargramostim

Intervention Description

Given subcutaneously

Intervention Type

Biological

Intervention Name(s)

therapeutic autologous dendritic cells

Intervention Description

Given subcutaneously

Primary Outcome Measure Information:

Title

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

Title

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

Title

Safety

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert O. Dillman, MD, FACP

Organizational Affiliation

Hoag Memorial Hospital Presbyterian

Official's Role

Study Chair

Facility Information:

Facility Name

Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32316978

Citation

Nistor GI, Dillman RO. Cytokine network analysis of immune responses before and after autologous dendritic cell and tumor cell vaccine immunotherapies in a randomized trial. J Transl Med. 2020 Apr 21;18(1):176. doi: 10.1186/s12967-020-02328-6.

Results Reference

derived

PubMed Identifier

31406564

Citation

Dillman RO, Cornforth AN, McClay EF, Depriest C. Patient-specific dendritic cell vaccines with autologous tumor antigens in 72 patients with metastatic melanoma. Melanoma Manag. 2019 May 31;6(2):MMT20. doi: 10.2217/mmt-2018-0010.

Results Reference

derived

PubMed Identifier

22996370

Citation

Dillman RO, Cornforth AN, Depriest C, McClay EF, Amatruda TT, de Leon C, Ellis RE, Mayorga C, Carbonell D, Cubellis JM. Tumor stem cell antigens as consolidative active specific immunotherapy: a randomized phase II trial of dendritic cells versus tumor cells in patients with metastatic melanoma. J Immunother. 2012 Oct;35(8):641-9. doi: 10.1097/CJI.0b013e31826f79c8.

Results Reference

derived

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

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