MelanomaPhase 1NCT01021059
A Phase I Study of Intravenous Recombinant Human IL-15 in Adults With Refractory Metastatic Malignant Melanoma and Metastatic Renal Cell Cancer
A Phase 1 study testing rh IL-15 in people with Melanoma and Carcinoma, Renal Cell, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Recombinant human interleukin-15 (rhIL-15) is a substance that is naturally produced in the body that has many properties that increase the activity and strength of the immune system, the body s natural defense system. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Melanoma, Carcinoma, Renal Cell
- What is being tested?
- rh IL-15
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2009to 25 Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years.
- Diagnosis of metastatic malignant melanoma or metastatic renal cell cancer confirmed by the Laboratory of Pathology, NCI.
- Patients must have metastatic malignant melanoma or metastatic renal cell 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.
- Patients must have measurable disease.
- DLCO/VA and FEV-1.0 greater than 50% of predicted on pulmonary function tests.
- AST and ALT less than 3 times the upper limit of normal.
Show all 12Show fewer
- Absolute neutrophil count greater than or equal to 1,500/mm(3).
- Platelets greater than or equal to 75,000/mm(3).
- PT/PTT within 1.5 times upper limit of normal. Patients with a history of DVT and who are on anticoagulation therapy may be eligible, provided their DVT was at least 8 weeks prior to enrollment and they have had no further complications.
- Karnofsky performance status greater than or equal to 70% (ECOG less than or equal to 1)
- Serum creatinine of less than or equal to 1.5 times the upper limit of normal.
- 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 greater than or equal to 3 months after completion of treatment and no signs of cerebral edema are eligible.
Who cannot join
- 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.
- 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.
- History of any hematopoietic malignancy.
- Life expectancy of less than 3 months.
- Presence of serum antibodies to IL-15.
- Patients must not have a marked baseline prolongation of QT/QTc interval (e.g., demonstration of a QTc interval greater than 500 milliseconds (ms)).
Show all 16Show fewer
- Documented HIV, active or chronic hepatitis B, hepatitis C or HTLV-I infection.
- A positive hepatitis B serology indicative of previous immunization (i.e., HBsAb positive and HBc Ab negative), or a fully resolved acute HBV infection is not an exclusion criterion.
- A positive hepatitis C serology is an exclusion criterion.
- Concurrent anticancer therapy (Including other investigational agents).
- History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible).
- History of autoimmune disease, with the exception of an autoimmune event associated with prior ipilimumab (anti-CTLA-4) therapy that has completely resolved for a period of 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 four months after completion of treatment).
- History of medical or psychiatric disease, active substance abuse or social circumstances which in the view of the Principal Investigator, would preclude safe treatment.
- Patients with cognitive impairment or likely to develop cognitive impairment while on study.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Study of Intravenous Recombinant Human IL-15(rhIL-15) in Adults With Metastatic Malignant Melanoma and Metastatic Renal Cell Cancer
Background:
- Recombinant human interleukin-15 (rhIL-15) is a substance that is naturally produced in the body that has many properties that increase the activity and strength of the immune system, the body s natural defense system. It is hoped that rhIL-15 can boost or strengthen patients immune systems and restore immune responses against cancer and infectious diseases like HIV.
- rhIL-15 is being studied in patients with malignant melanoma, an aggressive type of skin cancer, and in patients with renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. Researchers are interested in determining if rhIL-15 can help stimulate the immune system and aid in the treatment process for cancers that have not responded well to standard therapies.
Read more
Objectives:
- To determine whether rhIL-15 is safe and effective in the treatment of metastatic malignant melanoma or metastatic renal cell carcinoma
- To examine how the body processes rhIL-15 after each infusion and determine how it acts on the treated cancer.
Eligibility:
- Patients older than 18 years of age that have been diagnosed with metastatic malignant melanoma or metastatic renal cell carcinoma that has not responded to standard treatments.
- Eligible patients may not have received prior treatment with interleukin-2.
Design:
- Prior to treatment, patients will have baseline blood tests and imaging scans.
- Participants will be admitted to an in-patient unit of the NIH Clinical Center for this treatment. rhIL-15 will be given intravenously once a day for 12 consecutive days, for a total of twelve doses of the drug. The injection of rhIL-15 will take about 30 minutes. Patients will be evaluated daily before each treatment and more frequently if necessary.
- During the 12-day treatment and for at least 42 days from the start of the treatment, patients will be closely followed for possible side effects and for tumor response. Blood will be drawn frequently for monitoring purposes, and other procedures such as chest x-rays and imaging scans will be performed to monitor the state of the tumor and the patient response to treatment.
- After completing the rhIL-15 treatment and discharge from the hospital, patients will have an evaluation with a member of the research team once a week from the end of the treatment period to 42 days from the start of the treatment.
- Study doctors may ask patients to return for evaluation (including blood draws) at 3 and 6 months after the completion of the treatment, checking for potential long-term effects or toxicity of the treatment.
Background:
- Recombinant human interleukin-15 (rhIL-15) is a substance that is naturally produced in the body that has many properties that increase the activity and strength of the immune system, the body s natural defense system. It is hoped that rhIL-15 can boost or strengthen patients immune systems and restore immune responses against cancer and infectious diseases like HIV.
- rhIL-15 is being studied in patients with malignant melanoma, an aggressive type of skin cancer, and in patients with renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. Researchers are interested in determining if rhIL-15 can help stimulate the immune system and aid in the treatment process for cancers that have not responded well to standard therapies.
Objectives:
- To determine whether rhIL-15 is safe and effective in the treatment of metastatic malignant melanoma or metastatic renal cell carcinoma
- To examine how the body processes rhIL-15 after each infusion and determine how it acts on the treated cancer.
Eligibility:
- Patients older than 18 years of age that have been diagnosed with metastatic malignant melanoma or metastatic renal cell carcinoma that has not responded to standard treatments.
- Eligible patients may not have received prior treatment with interleukin-2.
Design:
- Prior to treatment, patients will have baseline blood tests and imaging scans.
- Participants will be admitted to an in-patient unit of the NIH Clinical Center for this treatment. rhIL-15 will be given intravenously once a day for 12 consecutive days, for a total of twelve doses of the drug. The injection of rhIL-15 will take about 30 minutes. Patients will be evaluated daily before each treatment and more frequently if necessary.
- During the 12-day treatment and for at least 42 days from the start of the treatment, patients will be closely followed for possible side effects and for tumor response. Blood will be drawn frequently for monitoring purposes, and other procedures such as chest x-rays and imaging scans will be performed to monitor the state of the tumor and the patient response to treatment.
- After completi...
Read the detailed description
Background:
- Interleukin-15 (IL-15) is a powerful immunostimulatory cytokine with a broad range of biological activities.
- In contrast to IL-2, IL-15 inhibits the activation-induced cell death (AICD) of T-cells and is not involved in the maintenance of CD4+CD25+ T regulatory cells that act as inhibitory checkpoints on the immune response.
- IL-15 is involved in the proliferation, differentiation and activation of CD8+ T-cells and NK-cells, and the maintenance of long term CD8+ memory T-cells.
- In preclinical studies, vaccinia-based vaccines expressing IL-15 induced long lasting, high-avidity cytotoxic CD8+ T-lymphocyte (CTL) mediated immunity, whereas the immunity mediated by IL-2 expressing vaccines was short-lived. Furthermore, IL-15 can overcome the lack of CD4 help in CTL induction.
- IL-15 is highly active against a number of syngeneic mouse tumor models and it is also effective in augmenting the activity of NK-cells and CD8+ T-cells in rhesus macaques indicating that it may be active against human cancers.
Objectives:
- The primary objective of this trial is to determine the safety, toxicity profile, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of intravenous recombinant human IL-15 (rhIL-15) administered as a daily intravenous bolus infusion for 12 consecutive days in subjects with metastatic malignant melanoma and renal cell cancer.
- Secondary objectives include determination of rhIL-15 pharmacokinetics, in particular the time course of the decline of rhIL-15 from the serum following intravenous administration and the definition of the immunogenicity of rhIL-15 in subjects receiving this drug.
- To characterize the biological effects of rhIL-15 on the proportions and absolute numbers of circulating NK-cells, and CD45RO+CD8+ T-cells and central or effector memory subsets based on expression of CD28, CD95, CCR7 and CD62L by flow cytometry and to determine its effects on the plasma levels of pro-inflammatory cytokines.
- Obtain preliminary information on the antitumor effects of repeat cycles of rhIL-15 in patients with metastatic malignant melanoma and renal cell cancer.
Eligibility Criteria:
- Patients greater than or equal to 18 years-old with pathologically confirmed metastatic malignant melanoma or metastatic renal cell cancer.
- Patients with metastatic renal cell cancer must either have refused treatment with, failed to tolerate, or have progressive disease after receiving sorafenib or sunitinib, and temsirolimus.
- Patients with measurable disease.
- Absolute granulocyte count (AGC) of at least 1500/mm(3) and a platelet count of at least 75,000/mm(3).
Design:
- This is a single institution, open-label, non-randomized 3 + 3 design phase I dose-escalation study to determine the safety, toxicity and MTD of rhIL-15 in patients with metastatic malignant melanoma and renal cell cancer.
- Groups of 3 to 6 patients will receive rhIL-15 at doses of 0.3, 1, 3, 7, 10, 15, 20 or 25 mcg/kg/day for 12 days provided that DLT had not been observed.
- Correlative protocol studies will be obtained prior to treatment and at specific times points during and after treatment including pharmacokinetics for the clearance of rhIL-15 from the serum, immunogenicity testing for the development of neutralizing anti-rhIL-15 antibodies and immunological study endpoint evaluation for the effect of rhIL-15 on immune cell subset populations and pro-inflammatory cytokine levels in the peripheral blood.
- Conditions
- Melanoma, Carcinoma, Renal Cell
- Being tested
- rh IL-15
- Keywords
- Biological Effects of rhIL-15, Estimate Antitumor Activity, rhIL-15 Pharmacokinetics, Dose and Safety Determination of IL-15, Kidney Cancer, Melanoma, Renal Cell Cancer
- Medical subject headings
- Melanoma, Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rh IL-15Biological
rh IL-15 daily for 12 days of 42 days cycle. Additional cycles may be given if patient is responding to therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | rh IL-15 daily for 12 days of 42 days cycle. Receives: Biological: rh IL-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety, toxicity profile, dose-limiting toxicity and a maximum tolerated dose if IV recombinant Human IL-15 administered in melanoma and renal cell cancers.
Measured: After first cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
10 Nov 200925 Oct 2016
- First posted26 Nov 2009 (estimated)
- Study start10 Nov 2009
- Primary completion31 May 2013
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas A Waldmann, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021059
- Sponsor's protocol ID
- 100021
- Other IDs
- 10-C-0021
- Status last verified
- 25 Oct 2016
- First submitted
- 25 Nov 2009
- Last updated
- 8 Nov 2019
- Results posted
- No
Publications
Waldmann TA, Tagaya Y. The multifaceted regulation of interleukin-15 expression and the role of this cytokine in NK cell differentiation and host response to intracellular pathogens. Annu Rev Immunol. 1999;17:19-49. doi: 10.1146/annurev.immunol.17.1.19.
PubMed 10358752Waldmann TA, Dubois S, Tagaya Y. Contrasting roles of IL-2 and IL-15 in the life and death of lymphocytes: implications for immunotherapy. Immunity. 2001 Feb;14(2):105-10. No abstract available.
PubMed 11239443Waldmann TA. The biology of interleukin-2 and interleukin-15: implications for cancer therapy and vaccine design. Nat Rev Immunol. 2006 Aug;6(8):595-601. doi: 10.1038/nri1901.
PubMed 16868550Conlon KC, Lugli E, Welles HC, Rosenberg SA, Fojo AT, Morris JC, Fleisher TA, Dubois SP, Perera LP, Stewart DM, Goldman CK, Bryant BR, Decker JM, Chen J, Worthy TA, Figg WD Sr, Peer CJ, Sneller MC, Lane HC, Yovandich JL, Creekmore SP, Roederer M, Waldmann TA. Redistribution, hyperproliferation, activation of natural killer cells and CD8 T cells, and cytokine production during first-in-human clinical trial of recombinant human interleukin-15 in patients with cancer. J Clin Oncol. 2015 Jan 1;33(1):74-82. doi: 10.1200/JCO.2014.57.3329. Epub 2014 Nov 17.
PubMed 25403209
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intravenous Recombinant Human IL-15(rhIL-15) in Adults With Metastatic Malignant Melanoma and Metastatic Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT01021059
- Acronym / sponsor ID
- 100021
- Conditions
- Melanoma, Carcinoma, Renal Cell
- Keywords
- Biological Effects of rhIL-15, Estimate Antitumor Activity, rhIL-15 Pharmacokinetics, Dose and Safety Determination of IL-15, Kidney Cancer, Melanoma, Renal Cell Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 10 Nov 2009
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Recombinant human interleukin-15 (rhIL-15) is a substance that is naturally produced in the body that has many properties that increase the activity and strength of the immune system, the body s natural defense system. It is hoped that rhIL-15 can boost or strengthen patients immune systems and restore immune responses against cancer and infectious diseases like HIV.
- rhIL-15 is being studied in patients with malignant melanoma, an aggressive type of skin cancer, and in patients with renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. Researchers are interested in determining if rhIL-15 can help stimulate the immune system and aid in the treatment process for cancers that have not responded well to standard therapies.
Objectives:
- To determine whether rhIL-15 is safe and effective in the treatment of metastatic malignant melanoma or metastatic renal cell carcinoma
- To examine how the body processes rhIL-15 after each infusion and determine how it acts on the treated cancer.
Eligibility:
- Patients older than 18 years of age that have been diagnosed with metastatic malignant melanoma or metastatic renal cell carcinoma that has not responded to standard treatments.
- Eligible patients may not have received prior treatment with interleukin-2.
Design:
- Prior to treatment, patients will have baseline blood tests and imaging scans.
- Participants will be admitted to an in-patient unit of the NIH Clinical Center for this treatment. rhIL-15 will be given intravenously once a day for 12 consecutive days, for a total of twelve doses of the drug. The injection of rhIL-15 will take about 30 minutes. Patients will be evaluated daily before each treatment and more frequently if necessary.
- During the 12-day treatment and for at least 42 days from the start of the treatment, patients will be closely followed for possible side effects and for tumor response. Blood will be drawn frequently for monitoring purposes, and other procedures such as chest x-rays and imaging scans will be performed to monitor the state of the tumor and the patient response to treatment.
- After completing the rhIL-15 treatment and discharge from the hospital, patients will have an evaluation with a member of the research team once a week from the end of the treatment period to 42 days from the start of the treatment.
- Study doctors may ask patients to return for evaluation (including blood draws) at 3 and 6 months after the completion of the treatment, checking for potential long-term effects or toxicity of the treatment.
Background:
- Recombinant human interleukin-15 (rhIL-15) is a substance that is naturally produced in the body that has many properties that increase the activity and strength of the immune system, the body s natural defense system. It is hoped that rhIL-15 can boost or strengthen patients immune systems and restore immune responses against cancer and infectious diseases like HIV.
- rhIL-15 is being studied in patients with malignant melanoma, an aggressive type of skin cancer, and in patients with renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. Researchers are interested in determining if rhIL-15 can help stimulate the immune system and aid in the treatment process for cancers that have not responded well to standard therapies.
Objectives:
- To determine whether rhIL-15 is safe and effective in the treatment of metastatic malignant melanoma or metastatic renal cell carcinoma
- To examine how the body processes rhIL-15 after each infusion and determine how it acts on the treated cancer.
Eligibility:
- Patients older than 18 years of age that have been diagnosed with metastatic malignant melanoma or metastatic renal cell carcinoma that has not responded to standard treatments.
- Eligible patients may not have received prior treatment with interleukin-2.
Design:
- Prior to treatment, patients will have baseline blood tests and imaging scans.
- Participants will be admitted to an in-patient unit of the NIH Clinical Center for this treatment. rhIL-15 will be given intravenously once a day for 12 consecutive days, for a total of twelve doses of the drug. The injection of rhIL-15 will take about 30 minutes. Patients will be evaluated daily before each treatment and more frequently if necessary.
- During the 12-day treatment and for at least 42 days from the start of the treatment, patients will be closely followed for possible side effects and for tumor response. Blood will be drawn frequently for monitoring purposes, and other procedures such as chest x-rays and imaging scans will be performed to monitor the state of the tumor and the patient response to treatment.
- After completi...
Detailed description
Background:
- Interleukin-15 (IL-15) is a powerful immunostimulatory cytokine with a broad range of biological activities.
- In contrast to IL-2, IL-15 inhibits the activation-induced cell death (AICD) of T-cells and is not involved in the maintenance of CD4+CD25+ T regulatory cells that act as inhibitory checkpoints on the immune response.
- IL-15 is involved in the proliferation, differentiation and activation of CD8+ T-cells and NK-cells, and the maintenance of long term CD8+ memory T-cells.
- In preclinical studies, vaccinia-based vaccines expressing IL-15 induced long lasting, high-avidity cytotoxic CD8+ T-lymphocyte (CTL) mediated immunity, whereas the immunity mediated by IL-2 expressing vaccines was short-lived. Furthermore, IL-15 can overcome the lack of CD4 help in CTL induction.
- IL-15 is highly active against a number of syngeneic mouse tumor models and it is also effective in augmenting the activity of NK-cells and CD8+ T-cells in rhesus macaques indicating that it may be active against human cancers.
Objectives:
- The primary objective of this trial is to determine the safety, toxicity profile, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of intravenous recombinant human IL-15 (rhIL-15) administered as a daily intravenous bolus infusion for 12 consecutive days in subjects with metastatic malignant melanoma and renal cell cancer.
- Secondary objectives include determination of rhIL-15 pharmacokinetics, in particular the time course of the decline of rhIL-15 from the serum following intravenous administration and the definition of the immunogenicity of rhIL-15 in subjects receiving this drug.
- To characterize the biological effects of rhIL-15 on the proportions and absolute numbers of circulating NK-cells, and CD45RO+CD8+ T-cells and central or effector memory subsets based on expression of CD28, CD95, CCR7 and CD62L by flow cytometry and to determine its effects on the plasma levels of pro-inflammatory cytokines.
- Obtain preliminary information on the antitumor effects of repeat cycles of rhIL-15 in patients with metastatic malignant melanoma and renal cell cancer.
Eligibility Criteria:
- Patients greater than or equal to 18 years-old with pathologically confirmed metastatic malignant melanoma or metastatic renal cell cancer.
- Patients with metastatic renal cell cancer must either have refused treatment with, failed to tolerate, or have progressive disease after receiving sorafenib or sunitinib, and temsirolimus.
- Patients with measurable disease.
- Absolute granulocyte count (AGC) of at least 1500/mm(3) and a platelet count of at least 75,000/mm(3).
Design:
- This is a single institution, open-label, non-randomized 3 + 3 design phase I dose-escalation study to determine the safety, toxicity and MTD of rhIL-15 in patients with metastatic malignant melanoma and renal cell cancer.
- Groups of 3 to 6 patients will receive rhIL-15 at doses of 0.3, 1, 3, 7, 10, 15, 20 or 25 mcg/kg/day for 12 days provided that DLT had not been observed.
- Correlative protocol studies will be obtained prior to treatment and at specific times points during and after treatment including pharmacokinetics for the clearance of rhIL-15 from the serum, immunogenicity testing for the development of neutralizing anti-rhIL-15 antibodies and immunological study endpoint evaluation for the effect of rhIL-15 on immune cell subset populations and pro-inflammatory cytokine levels in the peripheral blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: rh IL-15rh IL-15 daily for 12 days of 42 days cycle. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age greater than or equal to 18 years.
- Diagnosis of metastatic malignant melanoma or metastatic renal cell cancer confirmed by the Laboratory of Pathology, NCI.
- Patients must have metastatic malignant melanoma or metastatic renal cell 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.
- Patients must have measurable disease.
- DLCO/VA and FEV-1.0 greater than 50% of predicted on pulmonary function tests.
Key exclusion criteria (16 listed)
- 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.
- 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.
- History of any hematopoietic malignancy.
- Life expectancy of less than 3 months.
- Presence of serum antibodies to IL-15.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rh IL-15rh IL-15 daily for 12 days of 42 days cycle. Additional cycles may be given if patient is responding to therapy. | Biological | 1 |
Primary outcome
Determine the safety, toxicity profile, dose-limiting toxicity and a maximum tolerated dose if IV recombinant Human IL-15 administered in melanoma and renal cell cancers.
Time frame: After first cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Background: PubMed 10358752Waldmann TA, Tagaya Y. The multifaceted regulation of interleukin-15 expression and the role of this cytokine in NK cell differentiation and host response to intracellular pathogens. Annu Rev Immunol. 1999;17:19-49. doi: 10.1146/annurev.immunol.17.1.19.
- Background: PubMed 11239443Waldmann TA, Dubois S, Tagaya Y. Contrasting roles of IL-2 and IL-15 in the life and death of lymphocytes: implications for immunotherapy. Immunity. 2001 Feb;14(2):105-10. No abstract available.
- Background: PubMed 16868550Waldmann TA. The biology of interleukin-2 and interleukin-15: implications for cancer therapy and vaccine design. Nat Rev Immunol. 2006 Aug;6(8):595-601. doi: 10.1038/nri1901.
- Derived from this study: PubMed 25403209Conlon KC, Lugli E, Welles HC, Rosenberg SA, Fojo AT, Morris JC, Fleisher TA, Dubois SP, Perera LP, Stewart DM, Goldman CK, Bryant BR, Decker JM, Chen J, Worthy TA, Figg WD Sr, Peer CJ, Sneller MC, Lane HC, Yovandich JL, Creekmore SP, Roederer M, Waldmann TA. Redistribution, hyperproliferation, activation of natural killer cells and CD8 T cells, and cytokine production during first-in-human clinical trial of recombinant human interleukin-15 in patients with cancer. J Clin Oncol. 2015 Jan 1;33(1):74-82. doi: 10.1200/JCO.2014.57.3329. Epub 2014 Nov 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas A Waldmann, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rh IL-15 in people with Melanoma and Carcinoma, Renal Cell, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the safety, toxicity profile, dose-limiting toxicity and a maximum tolerated dose if IV recombinant Human IL-15 administered in melanoma and renal cell cancers. (time frame: After first cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01021059, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.