Epithelial Neoplasms, MalignantPhase 1NCT01417546
NHS-IL12 for Solid Tumors
A Phase 1 study testing NHS-IL-12 in people with Epithelial Neoplasms, Malignant and Epithelial Tumors, Malignant, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Neoplasms, Malignant, Epithelial Tumors, Malignant, Malignant Mesenchymal Tumor
- What is being tested?
- NHS-IL-12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2011to 14 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet the following criteria for participation:
- Participants must have histologically confirmed malignancy that is metastatic or unresectable locally advanced solid tumors.
- Participants must have completed or had disease progression on at least one prior line of disease-appropriate therapy for unresectable locally advanced or metastatic disease, or not be a candidate for therapy of proven efficacy for their disease due to an underlying physical condition.
- Participants may have disease that is measurable or non-measurable but evaluable disease (e.g. present on bone scan, rising tumor markers, non-measurable by RECIST but visible on CT scan). Participants with third space fluid (for example pleural effusions) as only site of disease will not be eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at study entry.
- Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of NHS-IL12 in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
Show all 21Show fewer
- Participants must have normal organ and marrow function as defined below:
- Hematological eligibility parameters (within 16 days of starting therapy):
- Absolute granulocyte count greater than or equal to 1,500/mcL
- Absolute lymphocyte count greater than or equal to 500/mcL
- Platelet count greater than or equal to 100,000/mcL
- hemoglobin greater than or equal to 9 g/dL
- Adequate hepatic function defined by a
- total bilirubin level less than or equal to 1.5 times ULN or in participants with Gilbert s syndrome, a total bilirubin less than or equal to 3.0, and
- aspartate aminotransferase (AST) and alanine-aminotransferase (ALT) levels less than or equal to 2.5 times ULN or, for participants with documented metastatic disease to the liver, AST and ALT levels less than or equal to 5 times ULN.
- Adequate renal function defined by an estimated creatinine clearance greater than 60 mL/min determined by 24-hour urine sampling or by the Cockcroft-Gault formula:
- Ccr = (140 age) (weight, kg) (constant)/[72 times Crserum (mg/100 mL). The constant is 1 for men and 0.85 for women OR Ccr = (140 age) (weight, kg) (constant)/Crserum (micro mol/L). The constant is 1.23 for men and 1.04 for women.
- CD4 lymphocyte count or other T lymphocyte subset count will not be used to determine eligibility.
- Participants must agree to practice effective contraception (both male and female subjects, if the risk of conception exists). The effects of NHS-IL12 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 30 days after the last dose. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- A minimum of 4 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade 1 or less from reversible all reversible toxicities related to prior therapy is required at study entry. Prior immune therapy (e.g. related vaccinia and fowlpox vaccines or antigen-specific peptides) is allowed.
- Subject must sign a written informed consent document.
Who cannot join
- Participants with any of the following will not be eligible for participation in this study:
- Participants who are receiving any other investigational concurrent anticancer treatment (chemotherapy, radiotherapy, immunotherapy, cytokine therapy except erythropoietin) at the time of enrollment except for disease specific appropriate hormonal therapies (e.g., ADT for prostate cancer, anti-estrogen for breast cancer, somatostatin analogue for neuroendocrine cancer)
- Concurrent use of systemic steroids (within 10 days of enrollment) will be excluded, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in participants with exacerations of reactive airway disease) must have completed at least 10 days prior to enrollment. Steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed at any time prior to enrollment.
- Participants who have previously received rIL-12
- Acquired immune defects such as HIV or innate immunodeficiency because this agent requires an intact immune system. In addition, these participants are at increased risk of lethal infections when treated with marrow-altering therapy.
- Systemic autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, Addison s disease, autoimmune disease associated with lymphoma).
Show all 23Show fewer
- History of organ transplant.
- History of or active inflammatory bowel disease (e.g., Crohn s disease, ulcerative colitis).
- Chronic infections (e.g., hepatitis B or C, tuberculosis).
- Known hypersensitivity or allergic reactions attributed to any compounds of similar chemical or biologic composition to the study medication, such as recombinant IL-12 or other monoclonal antibodies
- Known hypersensitivity to methotrexate
- History of brain metastases because of the poor prognosis of participants with brain metastases and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke < 6 months prior to enrollment, myocardial infarction < 6 months prior to enrollment, unstable angina, congestive heart failure (greater than or equal to NYHA III) or serious cardiac arrhythmia requiring medication.
- Pulmonary disease which, in the opinion of the investigator, may impair the patient s respiratory tolerance to moderate pulmonary fluid overload (e.g., interstitial lung disease, severe chronic obstructive pulmonary disease).
- All conditions associated with significant necrosis of nontumor-bearing tissues: esophageal or gastroduodenal ulcers < 6 months prior to enrollment, organ infarction < 6 months prior to enrollment, or active ischemic bowel disease.
- Presence of medically significant third space fluid (symptomatic pericardial effusion, ascites or pleural effusion requiring repetitive paracentesis).
- History of active alcohol or drug abuse.
- Any significant disease that, in the opinion of the investigator, may impair the patient s tolerance of study treatment.
- Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Pregnancy (absence to be confirmed by beta-human chorionic gonadotropin test) or lactation.
- Pleural effusion as the only evidence of metastatic disease.
- Expansion Cohorts only
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured as greater than or equal to 5 times 5 mm.
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: First In-Human Phase I Trial of NHS-IL12 in Patients With Metastatic Solid Tumors
Background:
- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is needed to test NHS-IL12 in people who have solid tumors that have not responded to treatment.
Read more
Objectives:
- To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age with solid tumors that have not responded to standard treatments.
Design:
- Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
- Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the hospital for at least one day to be monitored with frequent blood tests.
- Participants will have periodic blood samples taken before treatment and during the first week after treatment for the first two cycles. They will then have blood samples taken before treatment for the rest of the cycles.
Read the detailed description
Background:
- Interleukin-12 (IL-12) is a proinflammatory cytokine produced by activated phagocytes and dendritic cells (DCs) that plays a critical role in regulating the transition from innate to adaptive immunity.
- IL-12 has shown some promising clinical activity in phase I trials, including stabilization of disease in renal cancer patients with partial regression of a metastatic lesion, but has not proceeded further in clinical development due to toxicity.
- The NHS-IL12 concept is a strategy to reduce the toxicity associated with systemic administration of recombinant human IL-12 by selectively targeting delivery to tumors. The NHS-IL12 immunocytokine is composed of 2 IL-12 heterodimers, each fused to one of the H-chains of the NHS76 antibody, which has affinity for both single- and doublestranded DNA. Thus, NHS-IL12 targets delivery to regions of tumor necrosis where DNA has become exposed.
Objectives:
-To determine the dose-limiting toxicities (DLTs) and Maximum Tolerated Dose (MTD) of NHS-IL12 administered subcutaneously every 4 weeks and subcutaneously every 2 weeks in participants with metastatic or locally advanced solid epithelial or mesenchymal tumors.
Eligibility:
- Adults with histologically or cytologically proven metastatic or locally advanced solid epithelial or mesenchymal tumors, except unstable brain metastases, for which standard curative or palliative measures do not exist or are no longer effective.
- Adequate organ function as defined by liver, kidney, and hematologic laboratory testing.
- Participants with acquired immune defects, systemic autoimmune disease, history of organ transplant, history of chronic infections, or history of active inflammatory bowel disease will be excluded.
Design:
- With amendment D, this is a phase I, open-label, dose-escalation study designed to assess the safety, tolerability, PK, and biological and clinical activity of NHS-IL12. Goals are to determine the MTD of every 4-week doses at a starting dose level of 2 mcg/kg of NHS IL12 and to define the biologically optimal treatment schedule.
- Participants will be enrolled in cohorts of 3 to 6 participants using a standard 3+3 approach until MTD is reached.
- The trial will include a planned schedule-optimization amendment with up to 12 participants at each of the 2 dose levels that are of greater biologic interest (MTD and dose below MTD), which will be submitted as soon as a clear biological response (changes in circulating cytokine levels) is measured in at least 3 participants at a given dose level. With amendment L, a cohort will be enrolled evaluating NHS-IL12 at 12 mcg/kg every 2 weeks with dose escalation to 16.8 mcg/kg every 2 weeks if 0 of 3 or 1 of 6 DLTS are observed.
- With a maximum accrual ceiling of 83 participants, this study will be completed within 1year, enrolling up to 2-3 participants per month.
- Conditions
- Epithelial Neoplasms, Malignant, Epithelial Tumors, Malignant, Malignant Mesenchymal Tumor
- Being tested
- NHS-IL-12
- Keywords
- Maximum Tolerated Dose, Immune Response, Pharmacokinetics, Dose Escalation, Dose Limited Toxicity
- Medical subject headings
- Carcinoma, Malignant mesenchymal tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHS-IL-12Drug
NHS-IL12 is an investigational agent supplied to investigators by the manufacturer EMD Serono, Inc.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NHS-IL12 escalating doses on a 4 week schedule (Completed). Receives: Drug: NHS-IL-12 |
| 2 | Experimental | NHS-IL12 escalating doses on a 2 week schedule Receives: Drug: NHS-IL-12 |
| 3 | Experimental | NHS-IL12 expansion group on a 4 week schedule (Completed). Receives: Drug: NHS-IL-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs) and Maximum Tolerated Dose (MTD)
Determination of DLTs and MTD.
Measured: During the first 6 weeks or at least 2 weeks after administration of the second dose.
Secondary outcomes (1)
To determine immunogenicity, safety and pharmacokinetic parameters
Determination of safety, immune response and pharmacokinetic parameters
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study start12 Dec 2011
- Primary completion2 Jun 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Epithelial Neoplasms, MalignantStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James L Gulley, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417546
- Sponsor's protocol ID
- 110225
- Other IDs
- 11-C-0225
- Status last verified
- Oct 2021
- First submitted
- 13 Aug 2011
- Last updated
- 18 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Portielje JE, Kruit WH, Schuler M, Beck J, Lamers CH, Stoter G, Huber C, de Boer-Dennert M, Rakhit A, Bolhuis RL, Aulitzky WE. Phase I study of subcutaneously administered recombinant human interleukin 12 in patients with advanced renal cell cancer. Clin Cancer Res. 1999 Dec;5(12):3983-9.
PubMed 10632329Mortarini R, Borri A, Tragni G, Bersani I, Vegetti C, Bajetta E, Pilotti S, Cerundolo V, Anichini A. Peripheral burst of tumor-specific cytotoxic T lymphocytes and infiltration of metastatic lesions by memory CD8+ T cells in melanoma patients receiving interleukin 12. Cancer Res. 2000 Jul 1;60(13):3559-68.
PubMed 10910069Gollob JA, Mier JW, Veenstra K, McDermott DF, Clancy D, Clancy M, Atkins MB. Phase I trial of twice-weekly intravenous interleukin 12 in patients with metastatic renal cell cancer or malignant melanoma: ability to maintain IFN-gamma induction is associated with clinical response. Clin Cancer Res. 2000 May;6(5):1678-92.
PubMed 10815886Gatti-Mays ME, Tschernia NP, Strauss J, Madan RA, Karzai FH, Bilusic M, Redman J, Sater HA, Floudas CS, Toney NJ, Donahue RN, Jochems C, Marte JL, Francis D, McMahon S, Lamping E, Cordes L, Schlom J, Gulley JL. A Phase I Single-Arm Study of Biweekly NHS-IL12 in Patients With Metastatic Solid Tumors. Oncologist. 2023 Apr 6;28(4):364-e217. doi: 10.1093/oncolo/oyac244.
PubMed 36640137Bekaii-Saab T, Wesolowski R, Ahn DH, Wu C, Mortazavi A, Lustberg M, Ramaswamy B, Fowler J, Wei L, Overholser J, Kaumaya PTP. Phase I Immunotherapy Trial with Two Chimeric HER-2 B-Cell Peptide Vaccines Emulsified in Montanide ISA 720VG and Nor-MDP Adjuvant in Patients with Advanced Solid Tumors. Clin Cancer Res. 2019 Jun 15;25(12):3495-3507. doi: 10.1158/1078-0432.CCR-18-3997. Epub 2019 Feb 25.
PubMed 30804020
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First In-Human Phase I Trial of NHS-IL12 in Patients With Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01417546
- Acronym / sponsor ID
- 110225
- Conditions
- Epithelial Neoplasms, Malignant, Epithelial Tumors, Malignant, Malignant Mesenchymal Tumor
- Keywords
- Maximum Tolerated Dose, Immune Response, Pharmacokinetics, Dose Escalation, Dose Limited Toxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 12 Dec 2011 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 16 Aug 2011 (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:
- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is needed to test NHS-IL12 in people who have solid tumors that have not responded to treatment.
Objectives:
- To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age with solid tumors that have not responded to standard treatments.
Design:
- Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
- Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the hospital for at least one day to be monitored with frequent blood tests.
- Participants will have periodic blood samples taken before treatment and during the first week after treatment for the first two cycles. They will then have blood samples taken before treatment for the rest of the cycles.
Detailed description
Background:
- Interleukin-12 (IL-12) is a proinflammatory cytokine produced by activated phagocytes and dendritic cells (DCs) that plays a critical role in regulating the transition from innate to adaptive immunity.
- IL-12 has shown some promising clinical activity in phase I trials, including stabilization of disease in renal cancer patients with partial regression of a metastatic lesion, but has not proceeded further in clinical development due to toxicity.
- The NHS-IL12 concept is a strategy to reduce the toxicity associated with systemic administration of recombinant human IL-12 by selectively targeting delivery to tumors. The NHS-IL12 immunocytokine is composed of 2 IL-12 heterodimers, each fused to one of the H-chains of the NHS76 antibody, which has affinity for both single- and doublestranded DNA. Thus, NHS-IL12 targets delivery to regions of tumor necrosis where DNA has become exposed.
Objectives:
-To determine the dose-limiting toxicities (DLTs) and Maximum Tolerated Dose (MTD) of NHS-IL12 administered subcutaneously every 4 weeks and subcutaneously every 2 weeks in participants with metastatic or locally advanced solid epithelial or mesenchymal tumors.
Eligibility:
- Adults with histologically or cytologically proven metastatic or locally advanced solid epithelial or mesenchymal tumors, except unstable brain metastases, for which standard curative or palliative measures do not exist or are no longer effective.
- Adequate organ function as defined by liver, kidney, and hematologic laboratory testing.
- Participants with acquired immune defects, systemic autoimmune disease, history of organ transplant, history of chronic infections, or history of active inflammatory bowel disease will be excluded.
Design:
- With amendment D, this is a phase I, open-label, dose-escalation study designed to assess the safety, tolerability, PK, and biological and clinical activity of NHS-IL12. Goals are to determine the MTD of every 4-week doses at a starting dose level of 2 mcg/kg of NHS IL12 and to define the biologically optimal treatment schedule.
- Participants will be enrolled in cohorts of 3 to 6 participants using a standard 3+3 approach until MTD is reached.
- The trial will include a planned schedule-optimization amendment with up to 12 participants at each of the 2 dose levels that are of greater biologic interest (MTD and dose below MTD), which will be submitted as soon as a clear biological response (changes in circulating cytokine levels) is measured in at least 3 participants at a given dose level. With amendment L, a cohort will be enrolled evaluating NHS-IL12 at 12 mcg/kg every 2 weeks with dose escalation to 16.8 mcg/kg every 2 weeks if 0 of 3 or 1 of 6 DLTS are observed.
- With a maximum accrual ceiling of 83 participants, this study will be completed within 1year, enrolling up to 2-3 participants per month.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NHS-IL-12NHS-IL12 escalating doses on a 4 week schedule (Completed). |
| 2 | Experimental | Drug: NHS-IL-12NHS-IL12 escalating doses on a 2 week schedule |
| 3 | Experimental | Drug: NHS-IL-12NHS-IL12 expansion group on a 4 week schedule (Completed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participants must have histologically confirmed malignancy that is metastatic or unresectable locally advanced solid tumors.
- Participants must have completed or had disease progression on at least one prior line of disease-appropriate therapy for unresectable locally advanced or metastatic disease, or not be a candidate for therapy of proven efficacy for their disease due to an underlying physical condition.
- Participants may have disease that is measurable or non-measurable but evaluable disease (e.g. present on bone scan, rising tumor markers, non-measurable by RECIST but visible on CT scan). Participants with third space fluid (for example pleural effusions) as only site of disease will not be eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at study entry.
- Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of NHS-IL12 in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
Key exclusion criteria (23 listed)
- Participants with any of the following will not be eligible for participation in this study:
- Participants who are receiving any other investigational concurrent anticancer treatment (chemotherapy, radiotherapy, immunotherapy, cytokine therapy except erythropoietin) at the time of enrollment except for disease specific appropriate hormonal therapies (e.g., ADT for prostate cancer, anti-estrogen for breast cancer, somatostatin analogue for neuroendocrine cancer)
- Concurrent use of systemic steroids (within 10 days of enrollment) will be excluded, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in participants with exacerations of reactive airway disease) must have completed at least 10 days prior to enrollment. Steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed at any time prior to enrollment.
- Participants who have previously received rIL-12
- Acquired immune defects such as HIV or innate immunodeficiency because this agent requires an intact immune system. In addition, these participants are at increased risk of lethal infections when treated with marrow-altering therapy.
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 |
|---|---|---|
| NHS-IL-12NHS-IL12 is an investigational agent supplied to investigators by the manufacturer EMD Serono, Inc. | Drug | 1, 2, 3 |
Primary outcome
Dose-limiting toxicities (DLTs) and Maximum Tolerated Dose (MTD)
Time frame: During the first 6 weeks or at least 2 weeks after administration of the second dose.
Determination of DLTs and MTD.
1 secondary outcome
To determine immunogenicity, safety and pharmacokinetic parameters
Time frame: Ongoing
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 18 Oct 2021.
- Background: PubMed 10632329Portielje JE, Kruit WH, Schuler M, Beck J, Lamers CH, Stoter G, Huber C, de Boer-Dennert M, Rakhit A, Bolhuis RL, Aulitzky WE. Phase I study of subcutaneously administered recombinant human interleukin 12 in patients with advanced renal cell cancer. Clin Cancer Res. 1999 Dec;5(12):3983-9.
- Background: PubMed 10910069Mortarini R, Borri A, Tragni G, Bersani I, Vegetti C, Bajetta E, Pilotti S, Cerundolo V, Anichini A. Peripheral burst of tumor-specific cytotoxic T lymphocytes and infiltration of metastatic lesions by memory CD8+ T cells in melanoma patients receiving interleukin 12. Cancer Res. 2000 Jul 1;60(13):3559-68.
- Background: PubMed 10815886Gollob JA, Mier JW, Veenstra K, McDermott DF, Clancy D, Clancy M, Atkins MB. Phase I trial of twice-weekly intravenous interleukin 12 in patients with metastatic renal cell cancer or malignant melanoma: ability to maintain IFN-gamma induction is associated with clinical response. Clin Cancer Res. 2000 May;6(5):1678-92.
- Derived from this study: PubMed 36640137Gatti-Mays ME, Tschernia NP, Strauss J, Madan RA, Karzai FH, Bilusic M, Redman J, Sater HA, Floudas CS, Toney NJ, Donahue RN, Jochems C, Marte JL, Francis D, McMahon S, Lamping E, Cordes L, Schlom J, Gulley JL. A Phase I Single-Arm Study of Biweekly NHS-IL12 in Patients With Metastatic Solid Tumors. Oncologist. 2023 Apr 6;28(4):364-e217. doi: 10.1093/oncolo/oyac244.
- Derived from this study: PubMed 30804020Bekaii-Saab T, Wesolowski R, Ahn DH, Wu C, Mortazavi A, Lustberg M, Ramaswamy B, Fowler J, Wei L, Overholser J, Kaumaya PTP. Phase I Immunotherapy Trial with Two Chimeric HER-2 B-Cell Peptide Vaccines Emulsified in Montanide ISA 720VG and Nor-MDP Adjuvant in Patients with Advanced Solid Tumors. Clin Cancer Res. 2019 Jun 15;25(12):3495-3507. doi: 10.1158/1078-0432.CCR-18-3997. Epub 2019 Feb 25.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Epithelial Neoplasms, Malignant
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
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.
James L Gulley, 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 NHS-IL-12 in people with Epithelial Neoplasms, Malignant and Epithelial Tumors, Malignant, 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 21 inclusion and 23 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 18 Oct 2021. 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?
Dose-limiting toxicities (DLTs) and Maximum Tolerated Dose (MTD) (time frame: During the first 6 weeks or at least 2 weeks after administration of the second dose.). 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 NCT01417546, which also lists 5 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 18 Oct 2021.