Vaccine Therapy in Treating Patients With Advanced Stage III-IV Melanoma

NCT01744171 | Terminated Phase 1

• 2 other identifiers: I 215912NCI-2012-02231
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with stage III-IV melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells.

Conditions

Recurrent Melanoma; Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma; Stage IV Skin Melanoma

Outcome Measures

Primary Outcomes (1)

• MTD of recombinant human hsp110-gp100 chaperone complex melanoma vaccine based on the probability of dose-limiting toxicity (DLT), graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4

  DLT is defined as grade 3 or 4 toxicity or grade 3 injection site toxicity, with the exception of grade 3 rigors/chills which will be tolerated for 48-72 hours if attributable to vaccine reaction.

  Up to 30 days after the last vaccine dose

Secondary Outcomes (1)

• Objective tumor response according to RECIST version 1.1

  Up to 6 months

Study Arms (1)

Treatment (recombinant hsp110-gp100 chaperone complex vaccine)

EXPERIMENTAL

Patients receive recombinant hsp110-gp100 chaperone complex vaccine ID on days 1, 15, and 43 in the absence of unacceptable toxicity.

Biological: Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine; Other: Laboratory Biomarker Analysis

Interventions

Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine BIOLOGICAL

Given ID

Treatment (recombinant hsp110-gp100 chaperone complex vaccine)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (recombinant hsp110-gp100 chaperone complex vaccine)

Eligibility Criteria

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

You may qualify if:

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Absolute neutrophil count (ANC) \> 1500/uL
• Platelets \>= 120,000/uL
• Total bilirubin =\< 1.5 mg/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 1.5 x upper limit of normal (ULN)
• Serum creatinine =\< 1.5 mg/dL (if \> 1.5 mg/dL, then creatinine clearance should be \> 60 mL/min)
• Blood urea nitrogen (BUN) =\< 1.5 x ULN
• Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam
• An anticipated overall survival of at least 6 months
• Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
• Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status
• Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin \[IL\]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen)
• Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen)

You may not qualify if:

• Pregnant or nursing female patients
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug
• Received an investigational agent within 30 days prior to enrollment
• Melanoma specific systemic therapy within 30 days of enrollment
• A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease
• Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded
• Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis
• Previous history of splenectomy or whole spleen radiation
• Systemic immunoglobulin therapy within the last 30 days
• Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens
• Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years
• Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Melanoma

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

• John Kane

  Roswell Park Cancer Institute

  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

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: March 26, 2013
• Primary Completion: June 11, 2018
• Study Completion: June 11, 2018
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

US (1)