Aldesleukin With or Without Vaccine Therapy in Treating Patients With Stage IV Melanoma - Full Text View

Sponsors and Collaborators:	Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00726739

Purpose

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.

Condition	Intervention	Phase
Melanoma (Skin)	Drug: aldesleukin Drug: allogeneic large multivalent immunogen melanoma vaccine LP2307	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Aldesleukin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response [ Designated as safety issue: No ]
Survival at 1 and 2 years [ Designated as safety issue: No ]
Immune response [ Designated as safety issue: No ]

Estimated Enrollment:	102
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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.	Drug: aldesleukin Given subcutaneously Drug: allogeneic large multivalent immunogen melanoma vaccine LP2307 Given intradermally
Arm II (control): Active Comparator 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.	Drug: aldesleukin Given subcutaneously

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.

After completion of study treatment, patients are followed every 2 months for 1 year, every 3 months until disease progression, and then periodically thereafter.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of melanoma
- Stage IV disease
Measurable or nonmeasurable disease as defined by RECIST criteria
Shares ≥ 1 class I HLA allele (A1, A2, B7, B8, C7) with the HLA-type SK23-CD80+ cell
Concurrent enrollment in clinical trial UMN-MT1999-06 (IRB # 9904M01581, CPRC #2002LS032): "Vaccination with Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses" required
- Patients who received tetanus toxoid within the past 7 years do not receive the tetanus toxoid component of the vaccine
- Patients initially randomized to arm II on this study who cross over to arm I do not receive a second KLH vaccination on UMN-MT1999-06
No history of brain metastases or positive brain scan

PATIENT CHARACTERISTICS:

Karnofsky performance status (PS) 80-100% OR ECOG PS 0-1
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 g/dL
Bilirubin < 3 times upper limit of normal (ULN)
AST < 3 times ULN
Creatinine ≤ 2.0 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
FEV_1 ≥ 50% of predicted OR DLCO (corrected) ≥ 50% in patients meeting any of the following criteria:
- History of symptomatic pulmonary disease
- Symptoms of dyspnea, rales, wheezes, or rhonchi on physical exam
No cardiac disease, including any of the following:
- Myocardial infarction within the past 3 months
- Unstable angina
- Heart failure requiring medical intervention
- Exercise-induced ischemia
- Ejection fraction < 40% by MUGA or ECHO
No autoimmune disease requiring immunosuppressive therapy
No history of seafood allergy
No hypersensitivity to any component of the vaccine, including thimerosal
No history of neurologic symptoms from tetanus toxoid vaccine

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 4 weeks since prior systemic chemotherapy, immunotherapy, or biological therapy and recovered
No prior organ transplantation
No concurrent immunosuppressive therapy or steroid therapy (e.g., prednisone)
- Concurrent topical or inhalational steroids allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726739

Locations

United States, Minnesota
Masonic Cancer Center at University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Arkadiusz Dudek, MD 612-624-0123 dudek002@umn.edu

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Arkadiusz Dudek, MD

Masonic Cancer Center, University of Minnesota

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Masonic Cancer Center at University of Minnesota ( Arkadiusz Dudek )
Study ID Numbers:	CDR0000601698, UMN-2006LS046, UMN-0701M01001
Study First Received:	July 31, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00726739
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Aldesleukin
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms
Anti-HIV Agents
Neoplasms by Histologic Type
Anti-Retroviral Agents
Antineoplastic Agents

Therapeutic Uses
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009