Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Syndrome

Communicable Diseases

Necrosis

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

Virus Diseases

RNA Virus Infections

Genital Diseases

Urogenital Diseases

Slow Virus Diseases

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Analgesics

Thalidomide

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Tumor Necrosis Factor Inhibitors

Immunoglobulins

Interleukin-2

Adjuvants, Immunologic

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

IL-2 plus Anti-TNF or Thalidomide

Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an extension phase of this study in which the drug prednisone will be eliminated from the treatment regimen. Prednisone is associated with avascular necrosis, a condition that has been found in a number of patients in this study. Also, certain patients in this protocol may receive future interleukin-2 treatment cycles at home. Home administration of IL-2 injections involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle.

To be eligible for home administration of IL-2, patients must:

* Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1 year of treatment on the protocol, with at least two well-tolerated outpatient cycles at a stable dose.
* Have a history of tolerable side effects while receiving IL-2 without frequent medical interventions, intravenous fluid replacement or dose reductions.
* Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of the last two outpatient cycles.
* Have a strong relationship with a private physician or health-care provider who has been involved in the patient's care and is willing to help supervise the patient's care during each home IL-2 cycle.
* Live in a home with easy telephone access and have proved reliable in responding to telephone calls from clinic staff.
* Give the clinic staff contact information for a close friend or relative who will agree to serve as a caregiver during each home cycle, providing the patient non-medical assistance and checking on his or her condition daily.
* Have reasonable access to emergency medical services and a nearby medical facility.
* Have proved reliable and consistent in using sterile technique, reconstituting IL-2 vials and administering subcutaneous IL-2 injections.
* Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of their normal protocol participation.
* Have access to a home weight scale and be able to weigh themselves each day for safety monitoring.

Participants will receive IL-2 cycles on the same schedule they followed in their original protocol participation. They will be seen at the Clinical Center at regularly scheduled follow-up visits between cycles and for a medical evaluation and blood drawing before the start of each cycle to determine the safety of administering the cycle. During the home cycle, the patient's case manager or other team member will place monitoring telephone calls on days 2 and 4 of the cycle and again a week later. The timing and number of these calls may change depending on the findings of ongoing assessments of their usefulness. Patients will be required to notify the study team promptly of any complications or other problems that develop with therapy.

In the initial phase of this study, HIV-infected patients with CD4 counts between 200 and 500 were randomized to receive either IL-2 alone by continuous IV infusion for 5 days every 8 weeks, IL-2 plus anti-TNF antibody, or IL-2 plus thalidomide. The primary endpoints of this study are safety and tolerability of the IL-2/TNF inhibitor combination. Secondary endpoints will include changes in CD4 counts, frequency and severity of IL-2 related side effects, changes in serum TNF levels, and plasma viral load changes. The study period is one year, with an optional extension period to follow. Enrollment was for up to forty-five IL-2-naive patients.

In the amended phase of this study, up to 60 patients with HIV infection and CD4 counts equal to or greater than 350 will be studied to determine the ability of prednisone to ameliorate IL-2 related toxicity. Patients will be randomized to one of four groups: IL-2 alone; IL-2 plus prednisone; prednisone alone; no treatment. All four groups will be treated with a combination regimen of antiretrovirals to include at least one protease inhibitor. IL-2 will be dosed SQ at a starting dosage of 7.5 mlU bid x 5 days every 8 weeks, and prednisone (or placebo) will be dosed at 0.5 mg/kg/day during IL-2 cycles. Primary endpoints are frequency of IL-2 associated fatigue and fever, CD4 count changes, and viral load changes. Secondary endpoints include frequency of other IL-2 side effects, concomitant medication use, steroid associated side effects, cytokine changes during IL-2, and IL-2 total exposure in the IL-2 plus steroid vs. IL-2 plus placebo arms. The study period is one year with an optional extension period to follow.

Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist

A Randomized Trial of Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist in Patients With HIV-1 Infection

National Institute of Allergy and Infectious Diseases (NIAID)

Neoplasms

Digestive System Diseases

Rare Diseases

Carcinoma

Glomerulonephritis, Membranous

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Membranous Nephropathy

Pharmaceutical Solutions

solution, 60 mg, twice a week, until progression

MGN1703

Placebo

Hans-Joachim Schmoll

This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC Stage IV) with disease control after first-line standard chemotherapy regimens.

The phase 2 study will be conducted in patients with advanced colorectal carcinoma with disease control after first-line standard chemotherapy regimens with oral or intravenous fluoropyrimidines/leucovorin and irinotecan or oxaliplatin combined with a standard dose of bevacizumab lasted between 4.5 and 6 months, whereas the treatment duration with irinotecan or oxaliplatin should not be less than 3 months. Studies confirmed that completely chemotherapy-free intervals can be applicable in patients with advanced colorectal carcinoma who achieved disease control after initial first-line chemotherapy. Those therapy holidays minimize toxicity and unnecessary treatment load, reduce intensity of treatment, allow patients to stay longer on therapy, prevent therapy discontinuations due to toxicity, preserve the ability to re-administer chemotherapy later, and increase quality of life of the patients. The therapy-free interval represents a possibility to evaluate the efficacy of the study drug, MGN1703.

Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma

Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma With Disease Control After Initial First-line Therapy

Mologen AG

Blood and Lymph Conditions

Lymphoma

Hematologic Neoplasms

Hematologic Diseases

Lymphosarcoma

This portion of the study will evaluate the safety and pharmacology of a range of Tomivosertib (eFT-508) doses administered daily in subjects with previously treated lymphomas

This portion of the study provides cohort expansion to further explore the safety, pharmacology, and clinical activity of a single dose level of Tomivosertib (eFT-508) monotherapy in subjects with specific previously treated lymphomas

Tomivosertib (eFT-508)

Jeremy Barton, MD

This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of Tomivosertib (eFT-508). The study will evaluate oral daily administration of Tomivosertib (eFT-508). Treatment and study subject evaluation will be performed in 21-day cycles.

A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies

Effector Therapeutics

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Antirheumatic Agents

Cyclophosphamide

Imiquimod

Antineoplastic Agents, Alkylating

Alkylating Agents

Interferons

This arm has been closed as of 6/4/2014.

* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment

Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.

* Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment

Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.

For patients with only non-skin metastatic sites

First cycle (Cycle 1):

* Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Week 9: response assessment

Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.

Radiation

Sylvia Adams, MD

This study is to find an optimal dose of Imiquimod (IMQ) in the first part (Phase I) and test the effectiveness of the combination treatment of IMQ, cyclophosphamide (CTX), and radiotherapy (RT) in patients with skin metastases from breast cancer in the second part (Phase II). Currently this trial is in its Phase II part.

By harnessing the cytocidal and immunostimulatory properties of two local treatment modalities, RT and IMQ, an effective, adaptive immune response can be generated, resulting in systemic control of metastatic breast cancer after local treatment of cutaneous metastases. Additionally, based on investigators' recent preclinical data, the investigators intend to estimate in patients with metastatic breast cancer, if the addition of immunomodulatory cyclophosphamide can increase anti-tumor responses.

This trial originally had one treatment arm IMQ/RT(patients were treated with IMQ and RT). Recent evidence has emerged that the addition of immunomodulatory cyclophosphamide (CTX) increased anti-tumor responses, therefore the IMQ/RT arm is closed and the trial will continue with two additional cohorts (CTX/IMQ/RT and CTX/RT) which include cyclophosphamide.

Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases

Phase I/II Study of TLR7 Agonist Imiquimod, Cyclophosphamide, and Radiotherapy in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).

The response refers to the best overall response, based on European Organization for Research and Treatment of Cancer's definitions for chest wall tumors (Kouloulias, et al., 2002).

National Cancer Institute (NCI)

NYU Langone Health

This arm has been closed as of 6/4/2014.

Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.

Week 9: response assessment

Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.

Radiation Imiquimod

IMQ+RT

Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.

Week 9: response assessment

Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.

Radiation Imiquimod Cyclophosphamide

CTX/IMQ/RT

For patients with only non-skin metastatic sites

First cycle (Cycle 1):

Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W) Week 9: response assessment

Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.

Radiation Cyclophosphamide

CTX/RT

This arm has been closed as of 6/4/2014.

* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment

Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.

Radiation

Imiquimod

* Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.
* Week 9: response assessment

Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.

Radiation

Imiquimod

Cyclophosphamide

For patients with only non-skin metastatic sites

First cycle (Cycle 1):

* Week -1 (day -7): cyclophosphamide 200mg/m2 IV as single infusion
* Weeks 1-2: RT given to one site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)
* Week 9: response assessment

Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.

Radiation

Cyclophosphamide

Total

Mean Age

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Sylvia Adams

Systemic Tumor Response Rates (Complete Response+Partial Response)

Local Area A; irradiated area

Local Area B; non-irradiated area

Arm "CTX/RT" is not applicable, as it includes only patients with non-skin metastatic sites.

Local Skin Tumor Response Rates (Complete Response + Partial Response)

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Immune Checkpoint Inhibitors

Lung cancer patients received immunological checkpoint inhibitors (ICIs) and any immunomodulatory drugs.

Lung cancer patients received immunological checkpoint inhibitors (ICIs).

Shih-Ming TSAI, M.D., Ph.D.

The main objective of this study is to evaluate the change of neutrophil to lymphocyte ratio (NLR) after 6-week treatment of immune checkpoint inhibitors (ICIs) with or without immunomodulatory drugs and recognize the effect of post-treatment NLR and overall survival in advanced lung cancer patients by retrospective review.

In recent years, the therapeutic strategies for lung cancer have been enriched with small molecular targeted therapy and immunotherapy. In this retrospective study, we will observe the change in NLR and explore its possible association with survival among advanced lung cancer patients receiving Immune checkpoint inhibitors (ICIs) with and without such immuno-modulator, Astragalus Polysaccharide Injection. It can be used to understand the relationship between NLR values and the survival rate of lung cancer patients after ICIs treatment. Physicians can refer to this result to give patients the suitable treatment recommendations.

Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator

Change in Neutrophil to Lymphocyte Ratio (NLR) and Survival Among Advanced Lung Cancer Patients Receiving Immune Checkpoint Inhibitors With Immunomodulator: a Retrospective Study

Chung Shan Medical University

Attending physician

Carcinoma, Basal Cell

Neoplasms, Basal Cell

Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)

Imiquimod 5% cream

Erick Macedo

E M Macedo

E M macedo

This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.

This is a prospective study including patients presenting in aggregate primary lesions affected by nodular BCC of the eyelid (all subjects were submitted to incisional biopsy at 2 mm punch) at the commencement of this study. All were submitted to a local treatment with Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average). All subjects were submitted to a new incisional biopsy at 2 mm punch, after 12 weeks of treatment, and all of them were monitored monthly up to now.If positive biopsy (residue tumor) cases will managed with surgery.

Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma

University of Sao Paulo

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist	NCT00001475	Acquired Immuno... HIV Infection	IL-2 plus Anti-...	-	National Institutes of Health Clinical Center (CC)
Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma	NCT01208194	Advanced Colore...	MGN1703 Placebo	18 Years -	Mologen AG
A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies	NCT02937675	Lymphoma	Tomivosertib (e...	18 Years -	Effector Therapeutics
Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases	NCT01421017	Breast Cancer Metastatic Brea... Recurrent Breas...	Radiation Imiquimod Cyclophosphamid...	18 Years -	NYU Langone Health
Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist	NCT00001475	Acquired Immuno... HIV Infection	IL-2 plus Anti-...	-	National Institutes of Health Clinical Center (CC)
Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator	NCT04352335	Advanced Lung C...		20 Years -	Chung Shan Medical University
Change in NLR and Survival Among Advanced Lung Cancer Patients Receiving ICIs With Immunomodulator	NCT04352335	Advanced Lung C...		20 Years -	Chung Shan Medical University
Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma	NCT00803907	Carcinoma, Basa...	Imiquimod 5% cr...	18 Years - 90 Years	University of Sao Paulo
Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist	NCT00001475	Acquired Immuno... HIV Infection	IL-2 plus Anti-...	-	National Institutes of Health Clinical Center (CC)

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