Continuous Infusion of rhIL-15 for Adults With Advanced Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01572493
First received: April 5, 2012
Last updated: July 19, 2014
Last verified: June 2014
  Purpose

Background:

- People with cancer can have a weak immune system as a result of the cancer itself, or from prior treatments. . Still, treatments that stimulate the immune system have been shown to be effective against a number of different cancers. Recombinant human interleukin-15 (rhIL-15) is a drug that is designed to boost the immune system. Researchers are interested in seeing if rhIL-15 can strengthen the immune system's response against cancer. The drug will be given through a vein without a break for 10 days (240 hours).

Objectives:

  • To see rhIL-15 given as a continuous infusion over 10 days can be used to treat advanced cancer
  • Identify the side effects associated with this treatment.

Eligibility:

- Individuals at least 18 years of age with advanced cancer for which there are no effective treatments.

Design:

  • Participants screening procedures will include a physical exam and medical history, laboratory (blood) tests and x-rays (Imaging studies) to determine suitability for the protocol. --Appropriate participants with easily accessible tumor deposits may also be asked to have one pretreatment and one post (cycle 1) treatment tumor biopsy. .
  • Eligible participants will be admitted to the hospital for the rhIL-15 treatment and will spend about 12 days in the hospital. .
  • Participants will receive one 10 day infusion each cycle (about every 42 days) for as long as there are no serious side effects and the disease does not progress.
  • Participants will continue treatment as long as imaging studies show that the tumor continues to shrink or for two additional cycles after it has disappeared from the x-rays to make that the cancer is completely gone.
  • Participants who stop treatment for side effects or because their tumor did not shrink or stopped responding to the treatment will continue to have follow-up visits to monitor the outcome of the rhIL-15 treatment until there is evidence their cancer has progress or they begin another treatment.

Condition Intervention Phase
Carcinoma
Lymphoma
Biological: rh IL-15
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of a Continuous Intravenous Infusion of Recombinant Human Interleukin IL-15 (rhIL-15) in Adults With Metastatic Cancers

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • MTD and DLT [ Time Frame: after one cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 33
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IL-15 IV for first 10 days of each 42 day cycle
Biological: rh IL-15
IL-15 IV for first 10 days of each 42 day cycle

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA
  • Age greater than or equal to 18 years.
  • Patients must have histologically confirmed (by the NCI Pathology Department) solid tumor malignancy or lymphoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are associated with minimal patient survival benefit (as defined the Metabolism Branch physicians or if the patient refuses standard of care treatment ). Enrollment of patients with tumors that can be safely biopsied is encouraged.
  • Patients must have evaluable or measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan.
  • Patients must have recovered to < grade 1 CTCAEv4 from toxicity of prior chemotherapy or biologic therapy and must not have had prior chemotherapy or biologic therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C, 8 weeks for UCN-01).
  • Patients must be at least 1 month since any prior radiation or major surgery.
  • Patients on bisphosphonates for any cancer or on hormone therapy for prostate cancer will not need to discontinue this therapy to be eligible. However, patients with prostate cancer will need to have metastatic prostate cancer that has progressed despite hormonal therapy. Castrate testosterone levels occur within hours after castration and within 2 to 3 weeks of a luteinizing hormone-releasing hormone agonist. The current standard is to continue androgen suppression despite progressive disease.
  • DLCO/VA and FEV-1.0 > 50% of predicted on pulmonary function tests.
  • Serum creatinine of less than or equal to 1.5 X the upper limit of normal.
  • AST and ALT < 2.5 x the upper limit of normal.
  • Absolute neutrophil count greater than or equal to 1,500/mm(3) and platelets greater than or equal to 100,000/mm(3).
  • Karnofsky performance status greater than or equal to 70% or ECOG less than or equal to 1
  • 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 MRI scan at least 3 months after completion of treatment with no signs of cerebral edema are eligible.

EXCLUSION CRITERIA:

  • Patients who have received any systemic corticosteroid therapy within 3 weeks prior to the start of therapy with the exception of physiological replacement doses of cortisone acetate or equivalent.
  • Patients who have received any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies in the 4 weeks prior to the start of the study.
  • Life expectancy of less than 3 months.
  • History of complex ventricular or supraventricular arrhythmias
  • Documented HIV, active bacterial infections, active or chronic hepatitis B, or hepatitis C infection.
  • A positive hepatitis B serology indicative of previous immunization (i.e., HBsAb positive and HBc Ab negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion.
  • A positive hepatitis C serology is an exclusion criterion.
  • Concurrent anticancer therapy (including other investigational agents), with the exception of hormone therapy for prostate cancer.
  • Active CNS metastases (inactive CNS metastases are defined).
  • History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma not requiring therapy are eligible).
  • History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-CTLA-4) therapy that has been completely resolved for more than 4 weeks.
  • 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 4 months after completion of treatment).
  • Cognitive impairment, history of medical or psychiatric disease, other uncontrolled intercurrent illness, active substance abuse, or social circumstances, which in the view of the Principal Investigator (PI), would preclude safe treatment or the ability to give informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572493

Contacts
Contact: Tatyana Worthy, R.N. (301) 496-6653 worthyt@mail.nih.gov
Contact: Kevin C Conlon, M.D. (301) 402-2913 conlonkc@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Kevin C Conlon, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01572493     History of Changes
Other Study ID Numbers: 120113, 12-C-0113
Study First Received: April 5, 2012
Last Updated: July 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Immunotherapy
Effects of rhlL-15 on T-cells and NK cells
Pharmacokinetics of lL-15
Cytokine Therapy

Additional relevant MeSH terms:
Carcinoma
Lymphoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014