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A Phase I Trial of a Recombinant Human hsp110-gp100 Chaperone Complex Vaccine for Advanced Stage IIIB/C or IV Melanoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Recurrent Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

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Trial Information

A Phase I Trial of a Recombinant Human hsp110-gp100 Chaperone Complex Vaccine for Advanced Stage IIIB/C or IV Melanoma


PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) of human hsp (heat shock protein)110-gp100
chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to
recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients.

SECONDARY OBJECTIVES:

I. To examine the effect of the recombinant human hsp110-gp100 chaperone complex vaccine on
measurable clinical tumor.

II. To determine gp100 and hsp110 specific cell mediated and humoral immune responses
elicited by the chaperone complex vaccine.

III. To determine the effect of dose and serial administration of the chaperone complex
vaccine on cell mediated and humoral immune responses.

IV. To quantify patient characteristics (human leukocyte antigen [HLA] subtype, immune cell
function, etc.) that may correlate with immune response to the chaperone complex vaccine.

OUTLINE: This is a dose-escalation study.

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

After completion of study treatment, patients are followed up for 6 months.


Inclusion Criteria:



- 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 BRAF V600 mutation status

- Patients must have documented, clinically measurable 7th edition American Joint
Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or
stage IV (distant metastatic) melanoma; patients with brain metastases that have been
appropriately treated with surgical resection and/or radiation are eligible for
inclusion if they meet the performance status and life expectancy criteria; 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 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, vemurafenib, ipilimumab, or participation in a clinical
trial); 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, vemurafenib, ipilimumab, or participation in a clinical
trial)

- Stage IV patients must have refused, be ineligible for, or have failed at least 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)

Exclusion Criteria:

- 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 immunoglobin 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

- Concomitant systemic treatment with anti-histamine or non-steroidal anti-inflammatory
drugs; specific cyclooxygenase (COX)-2 inhibitors are permitted

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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 (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4

Outcome Description:

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.

Outcome Time Frame:

Up to 30 days after the last vaccine dose

Safety Issue:

Yes

Principal Investigator

John Kane

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 215912

NCT ID:

NCT01744171

Start Date:

April 2013

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma
  • Melanoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263