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

NCT00436930 | Completed Phase 2

• 2 other identifiers: CDR0000530026HOAG-HCC-06-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Arm I

EXPERIMENTAL

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; Biological: sargramostim

Arm II

EXPERIMENTAL

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; Biological: therapeutic autologous dendritic cells

Interventions

autologous tumor cell vaccine BIOLOGICAL

Given subcutaneously

Arm I

sargramostim BIOLOGICAL

Given subcutaneously

Arm I; Arm II

therapeutic autologous dendritic cells BIOLOGICAL

Given subcutaneously

Arm II

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead

Study Sites (1)

Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Related Publications (3)

• 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.

  PMID: 32316978 DERIVED

• 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.

  PMID: 31406564 DERIVED

• 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.

  PMID: 22996370 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

FANG vaccine; sargramostim

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert O. Dillman, MD, FACP

  Hoag Memorial Hospital Presbyterian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: December 1, 2006
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 10, 2014

Record last verified: 2009-06

Locations

US (1)