ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma

NCT00420888 | Completed Phase 2

• 1 other identifier: 06762004
• Study Type: interventional
• Target: 526
• Locations: 5 countries
• Sites: 51

Brief Summary

The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Time to death

  every 12 weeks, including after a maximum of 18 months of study treatment

Secondary Outcomes (11)

• Progression-free survival time

  every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period

• Objective tumor response rate

  every 12 weeks for the 18-month treatment period

• Best overall response

  every 12 weeks for the 18-month treatment period

• Duration of response

  every 12 weeks for the 18-month treatment period

• Changes in sum of target lesions

  every 12 weeks for the 18-month treatment period

Study Arms (3)

Safety group

EXPERIMENTAL

6-12 patients

Drug: ABR-217620/naptumomab estafenatox; Drug: IFN-alpha

1

EXPERIMENTAL

Drug: ABR-217620/naptumomab estafenatox; Drug: IFN-alpha

2

OTHER

Standard treatment with IFN-alpha without add-on of ABR-217620/naptumomab estafenatox

Drug: IFN-alpha

Interventions

ABR-217620/naptumomab estafenatox DRUG

10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times

Also known as: naptumomab estafenatox

1; Safety group

IFN-alpha DRUG

3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week

Also known as: Referon-A

1; 2; Safety group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed RCC (clear cell and papillary types)
• Metastatic or inoperable locally advanced RCC
• Eligible for therapy with IFN-alpha.
• Measurable disease defined by at least 1 measurable lesion on CT scan (lesion diameter greater than or equal to 2.0 cm by a standard CT scanner or greater than or equal to 1.0 cm by a spiral CT scanner)
• Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2)
• Karnofsky performance status greater than or equal to 70
• Age greater than or equal to 18
• Life expectancy greater than 3 months
• Baseline blood counts:
• Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L
• Platelets greater than or equal to 100 x 10\^9/L
• Haemoglobin greater than or equal to 100 g/L
• Baseline blood chemistry levels:
• Creatinine less than or equal to 1.5 x upper limit of normal (ULN)
• Bilirubin less than or equal to 2 x ULN

You may not qualify if:

• Pregnant or breastfeeding women
• Serious uncontrolled medical disorder or active infection ongoing or resolved within 2 weeks before first dose of study drug and that the investigator believes would impair the patient's ability to receive study drug
• History of malignancy within 5 years or concurrent malignancy, except successfully treated non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ or lobular carcinoma in situ of breast may be included
• History and/or signs of parenchymal brain metastases
• Significant cardiac disease including: history (within 6 months) or current unstable angina pectoris, congestive heart failure (NYHA stage III-IV), myocardial infarction within 12 months, or uncontrolled arterial hypertension.
• History of stroke within 5 years and/or transient ischemic attack within 6 months.
• Acute illness or evidence of infection, including unexplained fever (\>100.5ºF or 38.1ºC) within 2 weeks before start of treatment
• Treatment with biological response modifiers within 3 weeks prior to the start of treatment and up to the End-of-Study visit
• Treatment with beta-blockers, including topical therapy for glaucoma, within 5 days before start of treatment and during the 4-day ABR-217620/naptumomab estafenatox treatment
• Treatment with systemic corticosteroids within 2 weeks before start of treatment or likely need for such treatment during the study
• Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis
• Known positive serology for HIV
• Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of chronic virus hepatitis or known virus carrying; patients who recovered from Hepatitis A are allowed
• Treatment with anticoagulants within 2 weeks before start of treatment, except when used to maintain the patency of a central or peripheral venous line
• Radiotherapy less than 4 weeks before start of treatment

Sponsors & Collaborators

• Active Biotech AB: lead

Study Sites (51)

Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"

Pleven, 5800, Bulgaria

Location

1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital

Plovdiv, 4004, Bulgaria

Location

Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology

Sofia, 1431, Bulgaria

Location

Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna"

Sofia, 1527, Bulgaria

Location

Urology Clinic, General Hospital for Active Treatment "St. Anna"

Varna, 9002, Bulgaria

Location

Department of Chemotherapy, Inter-district Dispensary for Cancer Diseases with Inpatient Hospital

Veliko Tarnovo, 5000, Bulgaria

Location

Fundeni Clinical Institute - Urology Department

Bucharest, 022328, Romania

Location

Dinu Uromedica

Bucharest, 041345, Romania

Location

"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic

Bucharest, 050659, Romania

Location

"I. Chiricuta" Institute of Oncology

Cluj-Napoca, 400015, Romania

Location

E-URO Medical Center

Cluj-Napoca, 400016, Romania

Location

Provita Center SRL

Constanța, 900635, Romania

Location

Sibiu Clinical Country Hospital - Urology Clinic

Sibiu, 550245, Romania

Location

Oncomed SRL

Timișoara, 300239, Romania

Location

Arkhangelsk Regional Oncology Center

Arkhangelsk, Russia

Location

Chelyabinsk Regional Oncology Center

Chelyabinsk, 454087, Russia

Location

Republican Clinical Oncology Center

Kazan', 420029, Russia

Location

Kazan City Oncology Center

Kazan', 420111, Russia

Location

Research Institute of Urology

Moscow, 105425, Russia

Location

Russian Oncological Research Center n.a. N.N. Blokhin

Moscow, 115478, Russia

Location

Russian Research Center of Radiology

Moscow, 117997, Russia

Location

Medical Radiology Research Center

Obninsk, 249036, Russia

Location

Orenburg Regional Clinical Oncology Center

Orenburg, 460021, Russia

Location

Leningrad Regional Oncological Center

Saint Petersburg, 191104, Russia

Location

Municipal Aleksandrovskaya Hospital

Saint Petersburg, 193312, Russia

Location

Municipal Multi-Speciality Hospital #2

Saint Petersburg, 194354, Russia

Location

Municipal Hospital #26

Saint Petersburg, 196247, Russia

Location

Municipal Clinical Oncology Center

Saint Petersburg, 197022, Russia

Location

Central Research Institute of Roentgenology and Radiology

Saint Petersburg, 197758, Russia

Location

Research Institute of Oncology n.a. Professor N.N. Petrov

Saint Petersburg, 197758, Russia

Location

Municipal Hospital #15

Saint Petersburg, 198205, Russia

Location

Stavropol Territorial Clinical Oncology Center

Stavropol, 355047, Russia

Location

Regional Clinical Oncology Hospital

Yaroslavl, 150054, Russia

Location

Cherkassy Regional Oncology Center

Cherkassy, 18009, Ukraine

Location

Chernigov Regional Oncology Center

Chernihiv, 14029, Ukraine

Location

Urology Department, Dnepropetrovsk State Medical Academy

Dnipro, 49005, Ukraine

Location

City General Hospital #4

Dnipro, 49102, Ukraine

Location

Donetsk Regional Antitumor Center

Donetsk, 83092, Ukraine

Location

Ivano-Frankovsk Regional Oncology Center

Ivano-Frankivsk, 76000, Ukraine

Location

Kharkiv Regional Urology and Nephrology Center

Kharkiv, 61037, Ukraine

Location

Institute of Urology under the Academy of Medical Sciences of Ukraine, Department of Plastic and Supportive Urology

Kiev, 04053, Ukraine

Location

Institute of Urology under the Academy of Medical Sciences of Ukraine, Urology Department

Kiev, 04053, Ukraine

Location

State Regional Diagnostics and Treatment Oncology Center

Lviv, 79031, Ukraine

Location

Regional Oncology Center

Uzhhorod, 88014, Ukraine

Location

Addenbrooke's Hospital, Cambridge Clinical Trials Centre

Cambridge, CB2 0QQ, United Kingdom

Location

Derby Hospital NHS Trust

Derby, DE1 2QY, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

St. James's Institute of Oncology

Leeds, LS9 7TF, United Kingdom

Location

The Royal Marsden NHS Trust

London, SW6 6JJ, United Kingdom

Location

The Christie Hospital NHS Trust

Manchester, M20 4BX, United Kingdom

Location

South Wales Cancer Institute, Singleton Hospital

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (4)

• Hawkins R, Gore M, Shparyk Y, Bondar V, Gladkov O, Ganev T, Harza M, Polenkov S, Bondarenko I, Karlov P, Karyakin O, Khasanov R, Hedlund G, Forsberg G, Nordle Ö, Eisen T. A randomized phase 2/3 study of naptumomab estafenatox plus IFN-α vs IFN-α in advanced renal cell carcinoma. ASCO Annual Meeting 2013; Abstract ID: 3073.

  RESULT

• Eisen T, Hedlund G, Forsberg G, Nordle Ö, Hawkins R. Baseline biomarker trend analysis of a randomized phase 2/3 study of naptumomab estafenatox plus IFN-α vs IFN-α in advanced renal cell carcinoma. European Cancer Congress (ECCO) 2013; Abstract ID: 2710.

  RESULT

• Elkord E, Burt DJ, Sundstedt A, Nordle O, Hedlund G, Hawkins RE. Immunological response and overall survival in a subset of advanced renal cell carcinoma patients from a randomized phase 2/3 study of naptumomab estafenatox plus IFN-alpha versus IFN-alpha. Oncotarget. 2015 Feb 28;6(6):4428-39. doi: 10.18632/oncotarget.2922.

  PMID: 25669986 RESULT

• Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

  PMID: 37146227 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

naptumomab estafenatox; Interferon-alpha

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Thore Nederman, PhD

  Active Biotech AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 22, 2015

Record last verified: 2014-06

Locations

GB (7); RU (19); BU (6); RO (8); UA (11)