Recombinant Interleukin-15 in Treating Patients with Metastatic Melanoma or Kidney Cancer

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IBiomarker/Laboratory analysis, Treatment18 to 8510-C-0021
NCI-2015-00085, 100021, 10-C-0021 G, 9850, NCT01021059

Trial Description

Summary

This phase I trial studies the side effects and best dose of recombinant interleukin-15 in treating patients with melanoma or kidney cancer that has spread to other parts of the body. Recombinant interleukin-15 is a substance that may help strengthen the body’s immune system and allow it to attack cancer or other diseases.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine the safety, toxicity profile, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of recombinant human interleukin (IL)-15 (rhIL-15) in subjects with metastatic malignant melanoma and metastatic renal cell cancer.

SECONDARY OBJECTIVES:

I. Define the pharmacokinetic and pharmacodynamic characteristics of rhIL-15 in humans with the administration schedule defined above.

II. Determine the immunogenicity of rhIL-15 in subjects using a two-arm capture enzyme-linked immunosorbent assay (ELISA).

III. Obtain preliminary information on the effectiveness of rhIL-15 in increasing the proportion and absolute number of circulating natural killer (NK) cells, cluster of differentiation (CD)45RO+CD8+ T-cells and central or effector memory subsets based on expression of CD28, CD95, chemokine (C-C motif) receptor 7 (CCR7) and CD62L in study subjects by fluorescence-activated cell sorting (FACS) analysis.

IV. Obtain preliminary information on the antitumor effects of repeat cycles of rhIL-15 in patients with metastatic malignant melanoma and renal cell cancer.

OUTLINE:

Patients receive recombinant interleukin-15 intravenously (IV) over 30 minutes on days 1-12. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity for patients achieving response.

After completion of study treatment, patients are followed up for 3 months.

Eligibility Criteria

Inclusion Criteria:

Serum creatinine of =< 1.5 X the upper limit of normal

Karnofsky performance status >= 70% or Eastern Cooperative Oncology Group (ECOG) =< 1

Absolute neutrophil count >= 1,500/mm^3

Diagnosis of metastatic malignant melanoma or metastatic renal cell cancer confirmed by the Laboratory of Pathology, National Cancer Institute (NCI)

Central nervous system (CNS) metastases: Patients who remain asymptomatic after successful definitive treatment of brain metastases (i.e., surgical resection, curative whole brain irradiation, stereotactic radiation therapy, or a combination of these) demonstrating stable or improved radiographic appearance on magnetic resonance imaging (MRI) scan >=3 months after completion of treatment and no signs of cerebral edema are eligible

Platelets >= 75,000/mm^3

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x the upper limit of normal

Diffusion capacity of the lung for carbon monoxide (DLCO)/DLCO corrected for alveolar volume (VA) and forced expiratory volume in one second (FEV-1.0) > 50% of predicted on pulmonary function tests

Patients must have measurable disease

Patients must have metastatic malignant melanoma or metastatic renal cell cancer (American Joint Committee on Cancer [AJCC] stage IV [M1] or equivalent disease); metastatic renal cell cancer patients must either have refused treatment with, have been unable to tolerate or have experienced progressive disease after treatment with sorafenib or sunitinib, and temsirolimus

Exclusion Criteria:

Inability to give informed consent

Patients with cognitive impairment or likely to develop cognitive impairment while on study

Inability or refusal to practice effective contraception during therapy or the presence of pregnancy or active breastfeeding (men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for four months after completion of treatment)

History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4]) therapy that has completely resolved for a period of more than 4 weeks

History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)

Concurrent anticancer therapy (Including other investigational agents)

Documented human immunodeficiency virus (HIV), active or chronic hepatitis B, hepatitis C or human T-lymphotropic virus (HTLV)-I infection

A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis C antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion

Positive hepatitis C serology is an exclusion criterion

Patients must not have a marked baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration of a QTc interval > 500 milliseconds (ms)

Life expectancy of less than 3 months

History of any hematopoietic malignancy

Patients must not have received any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies in the 4 weeks prior to the start of the study

Patients must not have received any systemic corticosteroid therapy for 3 weeks prior to the start of therapy with the exception of physiological replacement doses of cortisone acetate or equivalent

History of medical or psychiatric disease, active substance abuse or social circumstances which in the view of the Principal Investigator, would preclude safe treatment

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NCI - Center for Cancer Research

  • National Cancer Institute
Thomas Alexander Waldmann, Principal Investigator

Trial Sites

U.S.A.

Maryland
Bethesda

Mark O Hatfield-Warren Grant Magnuson Clinical Center

Thomas Alexander Waldmann
Ph: 301-496-6656
Email: tawald@mail.nih.gov

Thomas Alexander Waldmann
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01021059

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.