Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

NCT00471471 | Completed Phase 1 DMC

• 4 other identifiers: 04-173NCI-2009-00159PCI-IRB-0607048CDR0000544402
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete Freund's adjuvant may make a stronger immune response and kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and how well vaccine therapy works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery.

Conditions

Intraocular Melanoma; Malignant Conjunctival Neoplasm; Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma; ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; iris melanoma; recurrent intraocular melanoma; metastatic intraocular melanoma; conjunctival melanoma; stage IIIA melanoma; stage IIIB melanoma; stage IIIC melanoma

Outcome Measures

Primary Outcomes (1)

• Safety

  Number of grade 2 or greater allergic reactions (including generalized urticaria) or any grade 3 or greater adverse event

  up to 1 year

Secondary Outcomes (3)

• Immunologic response

  up to 94 days

• Objective tumor regression

  2 months

• Depigmentation evaluation

  up to 2 years

Study Arms (1)

Peptide Vaccine + GM-CSF + Pfizer 3512676 in-ISA Oil

EXPERIMENTAL

The water-in-oil emulsion will consist of peptide (100 mcg/0.1 mL), GM-CSF (80 mcg/0.16 mL using lyophilized 500 mcg/vial reconstituted with 1 mL of sterile water), Pfizer PF3512676 (0.6 mg/0.04 mL using 15mg/mL vial) and 0.20 mLl of sterile saline. Vaccination will be given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).

Biological: Peptide vaccine; Biological: GM-CSF; Biological: PF3512676

Interventions

Peptide vaccine BIOLOGICAL

Multi-epitope peptide vaccine containing MART-1 (26-35, 27L), gp100 (209-217, 210M) and tyrosinase (368-376, 370D) peptides

Peptide Vaccine + GM-CSF + Pfizer 3512676 in-ISA Oil

GM-CSF BIOLOGICAL

80 mcg/0.16 mL using lyophilized 500 mcg/vial reconstituted with 1 mL of sterile water given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).

Also known as: Sargramostim

Peptide Vaccine + GM-CSF + Pfizer 3512676 in-ISA Oil

PF3512676 BIOLOGICAL

0.6 mg/0.04 mL given subcutaneously rotating truncal sites in the vicinity of the four nodal drainage groups of the four extremities, on days 1 and 15 of each cycle (1 cycle = 28 days) for a maximum of 13 cycles (1 year).

Also known as: CpG 7909, agatolimod

Peptide Vaccine + GM-CSF + Pfizer 3512676 in-ISA Oil

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed melanoma meeting the following criteria: * Unresectable recurrent disease * Stage III or IV disease * Cutaneous, ocular, or mucosal melanoma * Measurable disease as defined by the RECIST criteria * HLA-A2 positive * Prior brain metastases allowed provided adequate surgical or radiologic treatment for brain disease PATIENT CHARACTERISTICS: * ECOG performance status 0 or 1 * WBC ≥ 3,000/mm³ * Lymphocytes ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST and ALT ≤ 2.5 times ULN * Lactic dehydrogenase ≤ 2.0 times ULN * aPTT \< 40 seconds * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for ≥ 1 week before, during, and for ≥ 2 weeks after completion of study therapy * No conditions of immunosuppression * Negative titers for antinuclear antibody (≤ 1/80) and antidouble stranded DNA (≤ 1/10) * No serious illnesses including, but not limited to, any of the following: * Bleeding disorders * Autoimmune diseases * Severe obstructive or restrictive pulmonary diseases * Active systemic infections * Inflammatory bowel disorders * No serious cardiovascular disease including, but not limited to, any of the following: * Uncontrolled congestive heart failure * Hypertension * Cardiac ischemia * Myocardial infarction, * Severe cardiac arrhythmia * HIV1 and 2 negative * HTLV-1 negative * Hepatitis B and C negative * No significant psychiatric disease, medical intervention, or other condition that, in the opinion of the principal investigator, would limit study compliance * No active infection within the past week, including unexplained fever (temperature \> 38.1°C) PRIOR CONCURRENT THERAPY: * Fully recovered from prior major surgery * More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas), hormonal therapy, radiotherapy, or biological therapy * More than 1 week since prior antibiotics * More than 28 days since prior investigational agent * No prior vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides alone or in combination * Patients with history of vaccination with peptides other than MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides allowed * More than 4 weeks since prior and no concurrent systemic immunosuppressive therapy, including steroids * Patients on maintenance steroids given at physiologic doses because of adrenal insufficiency are eligible * More than 2 weeks since prior and no concurrent treatment with systemic steroids, including oral steroids, continuous use of topical steroid creams or ointments, or any inhaled steroids * No concurrent anticoagulants, except to keep an indwelling line patent * No other concurrent anticancer therapy, including chemotherapy, immunotherapy, radiotherapy, experimental programs, and/or surgery

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

Sponsors & Collaborators

• Ahmad Tarhini: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• Tarhini AA, Leng S, Moschos SJ, Yin Y, Sander C, Lin Y, Gooding WE, Kirkwood JM. Safety and immunogenicity of vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) in adjuvant with PF-3512676 and GM-CSF in metastatic melanoma. J Immunother. 2012 May;35(4):359-66. doi: 10.1097/CJI.0b013e31825481fe.

  PMID: 22495394 RESULT

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

Protein Subunit Vaccines; Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim; ProMune

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ahmad A. Tarhini, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 10, 2007
• Study Start: October 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

US (1)