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

NCT00726739 | Completed Phase 2 Results DMC

• 2 other identifiers: 2006LS046UMN-0701M01001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage IV Melanoma

Keywords

recurrent melanoma

Outcome Measures

Primary Outcomes (1)

• Median Time of Progression-free Survival

  Progression free survival (PFS) was measured in months from date of randomization to date of disease progression, or date of death. For patients who died without tumor progression, PFS assumes their deaths are randomly related to tumor progression. Therefore, PFS includes deaths if they came first.

  From Date of Randomization to Date of Disease Progression or Last Contact - up to 2 years.

Secondary Outcomes (4)

• Clinical Response of Lesion(s)

  Month 2 through Month 12

• Overall Survival at 2 Years

  2 Years

• Overall Survival at 1 Year

  1 Year

• Immune Response

  48 hours After Study Medication

Study Arms (3)

Arm I - LMI + aldesleukin

EXPERIMENTAL

Patients receive allogeneic large multivalent immunogen vaccine (LMI) 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.

Biological: aldesleukin; Biological: allogeneic large multivalent immunogen vaccine

Arm II (control) - aldesleukin

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.

Biological: aldesleukin

Arm III - Crossover Patients

EXPERIMENTAL

Patients who have progressive disease on Arm II were be offered crossover to Arm I provided they continued to meet all study criteria. Patients receive allogeneic large multivalent immunogen vaccine (LMI) 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

Biological: aldesleukin; Biological: allogeneic large multivalent immunogen vaccine

Interventions

aldesleukin BIOLOGICAL

IL-2 Alone - administer 10 x 10\^6 International Units subcutaneously (SQ) will be given on day 1 and day 2 every 4 weeks until disease progression or for a maximum of 12 treatment cycles.

Also known as: IL-2, Interleukin-2, Proleukin

Arm I - LMI + aldesleukin; Arm II (control) - aldesleukin; Arm III - Crossover Patients

allogeneic large multivalent immunogen vaccine BIOLOGICAL

Allogeneic tumor cell membrane-coated large multivalent immunogen (LMI \[1 x 10\^7, 5-μm silica spheres\]) will be given as an intradermal injection every 4 weeks for up to 12 injections. Each vaccine dose will be 0.2 ml.

Also known as: LMI vaccine

Arm I - LMI + aldesleukin; Arm III - Crossover Patients

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; Interleukin-2

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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Results Point of Contact

• Title: Arkadiusz Dudek, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

dudek002@umn.edu

612-624-0123

Study Officials

• Arkadiusz Dudek, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 1, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 28, 2017
• Results First Posted: December 13, 2012

Record last verified: 2017-12

Locations

US (1)