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Aldesleukin With or Without Vaccine Therapy in Treating Patients With Stage IV Melanoma

Information source: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage IV Melanoma

Intervention: aldesleukin (Biological); allogeneic large multivalent immunogen vaccine (Biological)

Phase: Phase 2

Status: Terminated

Sponsored by: Masonic Cancer Center, University of Minnesota

Official(s) and/or principal investigator(s):
Arkadiusz Dudek, MD, Principal Investigator, Affiliation: Masonic Cancer Center, University of Minnesota


RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving aldesleukin together with vaccine therapy may kill more tumor cells. It is not yet known whether aldesleukin is more effective with or without vaccine therapy in treating melanoma. PURPOSE: This randomized phase II trial is studying how well aldesleukin works when given with or without vaccine therapy in treating patients with stage IV melanoma.

Clinical Details

Official title: A Randomized Phase II Study of IL-2 With or Without an Allogeneic Large Multivalent Immunogen (LMI) Vaccine for the Treatment of Stage IV Melanoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Median Time of Progression-free Survival

Secondary outcome:

Clinical Response of Lesion(s)

Overall Survival at 2 Years

Overall Survival at 1 Year

Immune Response

Detailed description: OBJECTIVES: Primary

- To compare the progression-free survival of patients with stage IV melanoma treated

with aldesleukin with vs without allogeneic large multivalent immunogen melanoma vaccine LP2307. Secondary

- To compare the clinical response in patients treated with these regimens.

- To compare the 1- and 2-year survival rates in patients treated with these regimens.

- To determine whether an immune response is generated after vaccination in these

patients. OUTLINE: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive allogeneic large multivalent immunogen melanoma vaccine LP2307

intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

- Arm II (control): Patients receive aldesleukin SC on days 1 and 2. Treatment repeats

every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on arm I. Patients undergo blood sample collection periodically for correlative laboratory studies. Samples are analyzed for immune responses to keyhole limpet hemocyanin and tetanus toxoid (control antigens) by ELISA assay; IFN-γ production by CD8 T cells in response to melanoma-derived peptides by ELISpot assay; delayed-type hypersensitivity response to vaccination; and frequency of peripheral blood lymphocytes, including T cells, B cells, NK cells, and monocytes, by flow cytometry.

- Arm III Crossover: Patients who have progressive disease on Arm II will be offered

crossover to Arm I provided they continue to meet all study criteria. After completion of study treatment, patients are followed every 2 months for 1 year, every 3 months until disease progression, and then periodically thereafter.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Stage IV melanoma.

- Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed if at

least 4 weeks since last treatment. Patient must recover from the acute toxic effects of the treatment prior to study enrollment.

- Disease status must be that of measurable or nonmeasurable disease as defined by

Solid Tumor Response Criteria (RECIST)

- Karnofsky performance status >70% (Eastern Cooperative Oncology Group 0-1)

- Age 18 years or older

- Adequate organ function within 14 days of study enrollment including the following:

- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count

(ANC) ≥ 1. 5 x 10^9/L, platelets ≥100 x 10^9/L, and hemoglobin ≥ 10 g/dL

- Hepatic: bilirubin < 3 times the upper limit of normal (× ULN), aspartate

transaminase (AST) < 3 × ULN

- Renal: creatinine ≤ 2. 0

- Must share at least one class I HLA allele with the HLA-type SK23-CD80+ cell (class I

alleles (A1, A2, B7, B8, C7))

- Meets eligibility criteria for and agrees to enroll in "MT1999- 06: Vaccination with

Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses" (IRB # 9904M01581, CPRC #2002LS032)

- Women of childbearing potential and men whose partners are of childbearing potential

are required to use an effective method of contraception (ie, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 3 months after the last dose of study drug.

- Voluntary written informed consent before performance of any study-related procedure

not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion criteria:

- History of brain metastases or positive brain scan at on-study

- Immunosuppressive therapy i. e., prednisone or organ transplant patients, however

topical or inhalational steroids are allowed.

- Autoimmune diseases requiring immunosuppressive therapy.

- History of symptomatic pulmonary disease will have pulmonary function tests (PFTs)

performed. Patients with symptoms of dyspnea or rales, wheezes or rhonchi on physical exam will undergo PFTs. Those with FEV1 <50% of predicted or corrected DLCO <50% are not eligible.

- Patients with cardiac disease such as recent myocardial infarction (< 3 months

prior), unstable angina, or heart failure requiring medical intervention will undergo cardiac evaluation. Cardiac testing may include ECG, MUGA or echocardiogram, and/or thallium stress test as indicated to evaluate cardiac risks. Those patients with exercise-induced ischemia or an ejection fraction by MUGA or echocardiogram < 40% are not eligible.

- Due to the origin of the KLH protein, patients with a history of seafood allergy are

excluded from receiving KLH.

- Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury

derivative, is a contraindication (taken from tetanus toxoid package insert).

- The occurrence of any type of neurologic symptoms to tetanus vaccine in the past is a

contraindication to further use (taken from tetanus toxoid package insert).

- Subjects who have had tetanus toxoid within the last 7 years will not receive the

tetanus vaccine component of this

- Pregnant (positive pregnancy test) or lactating women. Use of LMI vaccine during

pregnancy is not approved for use by the FDA during pregnancy. IL-2 is pregnancy

category C - risk in pregnancy cannot be ruled out.

Locations and Contacts

Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota 55455, United States
Additional Information

Starting date: June 2008
Last updated: November 7, 2012

Page last updated: August 23, 2015

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