Blood and Lymph Conditions

All Conditions

Heart and Blood Diseases

Rare Diseases

Myeloproliferative Disorders

Thrombocytosis

Thrombocythemia, Essential

Blood Platelet Disorders

Hematologic Diseases

Bone Marrow Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Gastrointestinal Agents

All Drugs and Chemicals

Antineoplastic Agents

Antisickling Agents

Fibrinolytic Agents

Platelet Aggregation Inhibitors

Calcium Carbonate

Hydroxyurea

Anagrelide

Ropeginterferon alfa-2b (P1101) dosage: from 250 mcg to 500 mcg

Ropeginterferon alfa-2b

Anagrelide dosage: 0.5 mg per capsule, according to label and physician's judgement

Toshiaki Sato, MD/PhD

Craig Zimmerman, PhD

This is a Phase 3 open-label, multicenter, randomized, active-controlled study designed to compare the efficacy and safety and tolerability of P1101 compared with ANA after 12 months of treatment as second-line therapy for subjects with ET who have had a suboptimal or failed response to HU.

PharmaEssentia Corporation is developing a pegylated (PEG) IFN-α product, P1101, for the treatment of ET.

Available clinical data and experience with P1101 in PV shows that the compound, with proper dose modifications, is effective in controlling disease in a significant proportion of subjects with ET. Further, its increased serum half-life presents distinct advantages for ET treatment over that of standard IFN-α and other available PEG IFN-α therapy. This pivotal Phase 3 study will establish the efficacy and safety of P1101 in ET subjects.

In core study phase, the enrolled subjects will be randomized into two arms, the test arm is P1101, the control arm is ANA. The overall duration for each eligible patient is 14 months, including screening (1 month), treatment (12 months) and follow-up (1 month) period. Efficacy evaluations, safety assessments, and PK and immunogenicity evaluations of P1101 will be performed.

Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling, EQ-5D-3L, and MPN-SAF TSS completion.

Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs.

Subjects who completed the end of treatment (EoT) and safety follow-up (EoS) visits of the SURPASS ET study and may benefit from P1101 therapy have the opportunity to receive P1101 treatment.

Experimental Drug (Biological): Ropeginterferon alfa-2b (P1101), Q2W, SC injection Control Drug: Anagrelide, capsules, daily, p.o.

Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study.

platelets ≤400 x 10\^9/L AND white blood cells (WBC) \<9.5 x 10\^9/L

based on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)

absence of hemorrhagic or thrombotic events

PharmaEssentia

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Breast Neoplasms

Melanoma

Sarcoma

Carcinoma, Renal Cell

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Kidney Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Soft Tissue Sarcoma

Lymphosarcoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Interferons

Interferon-alpha

Interferon-alfa-1b

Antiviral Agents

Immunologic Factors

recombinant interferon alpha-1b

Ernest C. Borden, MD

RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in treating patients with stage IV solid tumors, lymphoma, or myeloma.

OBJECTIVES:

* Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV solid tumors, lymphoma, or myeloma.
* Determine the maximum tolerated dose (MTD) of IFN-α1b given daily by subcutaneous injection in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of interferon alfa-1b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma

Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma

National Cancer Institute (NCI)

The Cleveland Clinic

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urinary Bladder Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

BCG Vaccine

Intravesical administration of ADSTILADRIN into the bladder

ADSTILADRIN

Stephen Boorjian, MD

Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.

Recombinant IFN alpha2b has pleiotropic effects that contribute to antitumor activity in Non-Muscle Invasive Bladder Cancer (NMIBC). ADSTILADRIN is a non-replicating adenovirus vector harboring the human IFN alpha2b gene. When combined with the excipient Syn3, intravesical administration of the rAd-IFN results in transduction of the virus into the epithelial cell lining in the bladder. The IFN alpha2b gene is incorporated into the cellular DNA resulting in the synthesis and expression of large amounts of IFN alpha2b protein. Clinical studies have confirmed that IFN alpha2b protein can be measured in the urine of patients treated with ADSTILADRIN within 24 hours after dosing.

ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN® (rAd-IFN)/Syn3) Administered Intravesically to Patients With High Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

A patient in the CIS cohort was judged to have achieved CR where urine cytology was reported as normal, atypical, degenerative, reactive, inflammatory, or nonspecific AND cystoscopy was reported as normal or with findings that did not include evidence of low-grade or high-grade recurrence. Bladder biopsy, if performed (not mandatory), demonstrated an absence of low-grade or high-grade recurrence.

Durability will be measured by determining the number of patients without recurrence of high-grade disease using results from urine cytology, cystoscopy, and biopsy of the bladder.

Complete response rate will be measured by determining the number of patients without recurrence of high-grade disease using results from urine cytology, cystoscopy, and biopsy of the bladder.

Durability will be measured by determining the number of patients without recurrence of high-grade disease using results from urine cytology, cystoscopy, and biopsy of the bladder if clinically indicated.

The incidence of and time to cystectomy will be measured in the study

The incidence of and time to survival will be measured in the study

Measurement of anti-adenoviral antibody levels at each dosing period, withdrawal, and at 12 months were done. A patient was considered to have a positive immunogenic response in anti-adenoviral antibodies if a post-baseline titration demonstrated a greater than 2-fold increase from baseline.

The table represent data at any time during the 12 months period, which means that the patient will be included in the Yes group if they at any measurement during the trial has a 2-fold increase from baseline.

The type, incidence, relatedness and severity of treatment emergent adverse events of ADSTILADRIN as assessed by NCI-CTCAE V4.03 will be monitored.

FKD Therapies Oy

Society of Urologic Oncology Clinical Trials Consortium

Ferring Pharmaceuticals

The Month 12 final dataset was used for all Adverse Event Reporting data.

Patients had at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only or Ta/T1 high-grade disease with concomitant CIS and were "BCG unresponsive" which referred to patients with high-grade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term "BCG unresponsive" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with CIS within 12 months of their last intravesical treatment with BCG or relapsed with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.

Carcinoma in Situ

Patients had at entry, confirmed by a pathology report Ta/T1 high-grade disease without concomitant CIS and were "BCG unresponsive" which referred to patients with high-grade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term "BCG unresponsive" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with high-grade Ta/T1 high-grade disease without concomitant CIS within 12 months of their last intravesical treatment with BCG or relapsed with high- grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.

Ta/T1 High-grade Disease Without Concomitant CIS

Total Treatment-Emergent Adverse Events in the Study.

TEAE Total Study

Patients with Carcinoma in situ (CIS) with or without concomitant high-grade Ta or T1 papillary disease

Patients with high-grade Ta or T1 papillary disease (without concomitant CIS)

Papillary Disease

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Height

Weight

Body Mass Index

Total ECOG of 0

Total ECOG of 1

Total ECOG of 2

The ECOG performance status was assessed according to a scale from 0 to 5, where 0 is fully active, able to carry on all pre-disease performance without restriction and where 4 is completely disabled, cannot carry on any self-care, totally confined to bed or chair and 5 is dead.

ECOG Status

Global Clinical Compliance

CIS participants had at entry, confirmed by a pathology report: Carcinoma in situ (CIS) only or Ta/T1 highgrade disease with concomitant CIS AND were "BCG unresponsive" which referred to patients with highgrade NMIBC who were unlikely to benefit from and who did not receive further intravesical BCG. The term "BCG unresponsive" included patients who did not respond to BCG treatment and had a persistent high-grade recurrence within 12 months after BCG was initiated, and those who, despite an initial CR to BCG, relapsed with CIS within 12 months of their last intravesical treatment with BCG or relapsed with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG.

Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure.

Number of Patients With a Complete Response Rate in Patients With Carcinoma in Situ (CIS), With or Without Concomitant High-grade Ta or T1 Papillary Disease.

Durability of Complete Response in Patients With CIS (With or Without Concomitant Ta or T1 Papillary Disease) Who Achieve a Complete Response.

Rate of Event-free Survival, Where Event-free Survival is Defined as High-grade Recurrence Free Survival in Patients With High-grade Ta or T1 Disease (Without Concomitant CIS)

Durability of Event-free Survival in Patients With High-grade Ta or T1 Papillary Disease (Without Concomitant CIS), Who Have no Recurrence of High-grade Ta or T1 Papillary Disease.

Incidence of Cystectomy in the Study

Overall Survival in All Patients

Patients with Positive Immunogenic Response in Anti-Adenoviral Antibodies at Post-Baseline based on patients who have achieved High-Grade Recurrence Free Survival at 12 months

Anti-adenoviral Antibody Levels for Correlation to Response Rate

Safety of ADSTILADRIN

Durability of Response During the Long Term Follow up Period.

Overall Study

Adenocarcinoma

Clear Cell Renal Cell Carcinoma

Analgesics

Vaccines

Bevacizumab

Interleukin-2

Interferon alpha-2

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)

DC Vaccine therapy 10E7 intranodally every cycle

DC vaccine

IL-2

Marc S Ernstoff, MD

Immune therapies, such as a IL-2, for metastatic renal cell carcinoma (mRCC) are designed to mobilize immune effector cells that recognize and destroy cancer. The investigators have recently observed a 50% objective response rate (16% CR) in mRCC patients treated with autologous tumor lysate -dendritic cell (DC)-vaccine, IL-2 and interferon alfa (IFN). New agents inhibiting vascular endothelial growth factor (VEGF) pathways have demonstrated significant benefit in mRCC patients as well, but rarely induce CRs. High blood VEGF is associated with poor response to IL-2 and can cause tumor specific immune dysregulation. To test whether complementary mechanisms of immune activation and disruption of regulatory pathways enhance outcome the investigators plan to treat 24 mRCC patients in a phase II trial using bevacizumab, DC vaccine, IL-2, and IFN. Observations from this project will be used in the development of novel cancer therapies which, if successful, will decrease the burden of cancer on the public.

The investigators propose to determine 1) the objective clinical response rate to treatment and progression free survival, 2) the clinical and autoimmune related toxicity profile of therapy, and 3) the treatment related tumor-specific immune response and the relationship of tumor-specific immune response and objective clinical response.

All eligible patients will receive a total of five treatment weeks, each consisting of approximately 5 days. Prior to therapy, patients will undergo apheresis for DC preparation. DC-Tumor vaccines will be frozen in 90% pooled human AB serum/ 10% DMSO to be used for treatment Patients will be dosed with bevacizumab (10mg/kg, Genentech) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2, Novartis), and three subcutaneous injections of IFNa-2b (6 MiU, Schering -Plough Corp.) (every other day). The first two treatment weeks, the induction phase, will be separated by a 9 day rest. Three additional treatment weeks, the maintenance phase, will be separated by 23 rest days.

Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients

A Phase II Study of VEGF Blockade With Bevacizumab Combined With Autologous Tumor/Dendritic Cell Vaccine (DC Vaccine), Interleukin-2 (IL-2) and Interferon-α-2b (IFNα-2b) in Patients With Metastatic Renal Cell Carcinoma (RCC)

percent of CD4 and CD8 positive lymphocyte subsets

To characterize the clinical and autoimmune related toxicity profile of the combined treatment regimen using CTCAE 3. Toxicity reported are those expected from high dose IL-2 and were not considered adverse events.

Dartmouth-Hitchcock Medical Center

Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)

DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle

Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks

IL-2: IL-2 18 MiU/m2 CI 5 days

IFN: IFN 6 MiU subc TIW

Bevacizumab,IL-2, IFN, DC Vaccine

Age is the mean of the age of the 8 patients at time of consent for study participation.

Age, Continuous

Number was the actual number of patients who signed consent and received treatment on study.

This study closed early due to difficulty enrolling patients with enrollment limited due to new competing therapies. Though enrollment numbers per statistical design were not met, the primary objective may still be reviewed.

Dr. Marc Ernstoff

Progression Free Survival

To Characterize the Number of Participants With Clinical and Autoimune Related Toxicity of Treatment

CD4 Central memory: baseline

CD4 Central memory: Day 28

CD4 Central memory: Day 70

CD8 Central memory: baseline

CD8 Central memory: day 28

CD8 Central memory: day 70

Peripheral blood lymphocyte subsets: 5 subjects at baseline and same 5 at day 70. 6 subjects analyzed at day 28

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance	NCT04285086	Essential Throm...	Ropeginterferon... Anagrelide	18 Years -	PharmaEssentia
Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma	NCT00276536	Breast Cancer Kidney Cancer Lymphoma Melanoma Multiple Myelom... Sarcoma Unspecified Adu...	recombinant int... IFN	18 Years - 120 Years	The Cleveland Clinic
ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)	NCT02773849	Superficial Bla...	ADSTILADRIN	18 Years -	Ferring Pharmaceuticals
Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance	NCT04285086	Essential Throm...	Ropeginterferon... Anagrelide	18 Years -	PharmaEssentia
Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma	NCT00276536	Breast Cancer Kidney Cancer Lymphoma Melanoma Multiple Myelom... Sarcoma Unspecified Adu...	recombinant int... IFN	18 Years - 120 Years	The Cleveland Clinic
Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients	NCT00913913	Metastatic Rena...	DC vaccine Bevacizumab IL-2 IFN	18 Years -	Dartmouth-Hitchcock Medical Center
Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients	NCT00577993	Lymphoma	Fludarabine Novantrone Decadron Rituximab Interferon Doxorubicin Vincristine Bleomycin Cyclophosphamid... Etoposide Cisplatin Ara-C Methyl-Predniso... Procarbazine Prednisone	- 76 Years	M.D. Anderson Cancer Center
Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients	NCT00913913	Metastatic Rena...	DC vaccine Bevacizumab IL-2 IFN	18 Years -	Dartmouth-Hitchcock Medical Center
ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)	NCT02773849	Superficial Bla...	ADSTILADRIN	18 Years -	Ferring Pharmaceuticals
Anakinra in Previously Untreated Chronic Lymphocytic Leukemia Patients	NCT04691765	Chronic Lymphoc...	Kineret	18 Years -	Sunnybrook Health Sciences Centre

Spots Global Cancer Trial Database for ifn

Every month we try and update this database with for ifn cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ifn

Every month we try and update this database with for ifn cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ifn cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.