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IMC-1121B in Patients With Metastatic Renal Cell Carcinoma With Disease Progression on or Intolerance to Tyrosine Kinase Inhibitor Therapy
This study is currently recruiting participants.
Verified by ImClone Systems, January 2009
Sponsored by: ImClone Systems
Information provided by: ImClone Systems
ClinicalTrials.gov Identifier: NCT00515697
  Purpose

The purpose of this study is to determine whether IMC-1121B is effective treatment in patients with metastatic renal cell carcinoma who have developed progressive disease or become intolerant to tyrosine kinase inhibitor therapy.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: 1121B
Phase II

Drug Information available for: Tyrosine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: Phase II Single Arm Study of IMC-1121B in Patients With Metastatic Renal Cell Carcinoma With Disease Progression on or Intolerance to Tyrosine Kinase Inhibitor Therapy

Further study details as provided by ImClone Systems:

Primary Outcome Measures:
  • Patients will be evaluated for response after every 6 weeks. [ Time Frame: Response to treatment is Response Evaluation Criteria in Solid Tumors (RECIST). ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: August 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Injectable solution in single-use, 50 mL vials containing 250 mg (5.0 mg/mL)of product administered as an i.v. infusion at 8 mg/kg every 2 weeks in the absence of disease progression or other withdrawal criteria. Cycles will be 14 days in length. As additional safety, pharmacokinetic and efficacy data are available from phase I studies, the dose and schedule may be modified.
Drug: 1121B
IMC-1121B injectable solution in single-use, 50 mL vials containing 250 mg (5.0 mg/mL)of product administered as an i.v. infusion at 8 mg/kg every 2 weeks in the absence of disease progression or other withdrawal criteria. Cycles will be 14 days in length. As additional safety, pharmacokinetic and efficacy data are available from phase I studies, the dose and schedule may be modified.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. The patient has histologically or cytologically confirmed clear cell RCC.
  2. The patient is ≥ 18 years of age.
  3. The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 or Karnofsky Performance Status (KPS) ≥ 80%.
  4. The patient has had a prior nephrectomy (as therapy for RCC).
  5. The patient has metastatic RCC.
  6. The patient has a life expectancy of > 3 months.
  7. The patient has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
  8. The patient has received prior therapy with a TKI (sunitinib and/or sorafenib) with either disease progression on TKI therapy (progression within 60 days of the last dose of TKI) or intolerance to TKI (unable to continue therapy because of side-effects). A patient with progression during a protracted treatment break is not eligible unless the patient has had progression or intolerance as defined above.
  9. The patient has resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 (NCI-CTCAE).
  10. The patient has adequate hematological functions (absolute neutrophil count [ANC] ≥ 1500 cells/mL, hemoglobin ≥ 9 g/dL and platelets ≥ 100,000 cells/mL).
  11. The patient has adequate hepatic function (bilirubin within normal limits [WNL], aspartate transaminase [AST] and/or alanine transaminase [ALT] ≤ 2.5 times the upper limit of normal [ULN], or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases).
  12. The patient has normal renal function or mild renal dysfunction (creatinine ≤ 2.2 mg/dL).
  13. The patient's urinary protein ≤ 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study).
  14. The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.8 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight (LMW) heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices).
  15. The patient is able to provide informed written consent.
  16. The patient, if sexually active, is postmenopausal (last menstrual period > 2 years prior to study), surgically sterile, or is using effective method of contraception in the opinion of the investigator.
  17. The patient, if female, must have a negative serum pregnancy test upon entry into this study.
  18. The patient has a normal thyroid stimulating hormone (TSH) value. Patients with an abnormal TSH may be eligible provided they meet all other eligibility criteria and have ECOG performance status 0-1. Patients with an abnormal TSH value require a full thyroid evaluation prior to enrollment. Endocrinology consultation may be performed at the discretion of the investigator.
  19. The patient has serum calcium within normal limits.

Exclusion Criteria

  1. The patient has received prior treatment with bevacizumab.
  2. The patient has known brain or leptomeningeal metastases.
  3. The patient has received prior chemotherapy for RCC.
  4. The patient has received antitumor therapy (biologic agents, major surgery, or investigational agent) within 28 days prior to enrollment on study. The patient has received radiation therapy within 14 days prior to enrollment on study. Patients with metastasis in weight bearing bones at high risk for pathologic fracture may participate provided that appropriate surgical intervention and/or radiation therapy is undertaken and completed at least 28 days prior to enrollment.
  5. The patient has received > 1 prior bioimmunotherapy regimens (defined as either interleukin-2 or interferon alpha given as monotherapy, concurrently, or sequentially as planned).
  6. The patient has a concurrent active malignancy other than adequately treated non-melanomatous skin cancer or other non-invasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years.
  7. The patient has a nonhealing wound or ulcer.
  8. The patient has a known alcohol or drug dependency.
  9. The patient is pregnant or breastfeeding.
  10. The patient has a coexisting medical or psychiatric problem of sufficient severity to limit compliance with the study and/or increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results.
  11. The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator.
  12. The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515697

Contacts
Contact: Stephanie Wagner, RN, BSN 908-541-8279 stephanie.wagner@imclone.com

Locations
United States, California
California Pacific Medical Center Not yet recruiting
San Francisco, California, United States, 94115
Contact: David R Minor, MD     415-885-8600        
Principal Investigator: David R Minor, MD            
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Walter Stadler, MD, FACP     773-702-4150        
Contact: Edwin Posadas, MD     773-834-5137        
Principal Investigator: Walter Stadler, MD            
Sub-Investigator: Edwin Posadas            
United States, Louisiana
Jayne Gurtler Recruiting
Metairie, Louisiana, United States, 70006
Contact: Jayne Gurtler, MD     504-885-0577        
Principal Investigator: Jayne Gurtler, MD            
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Toni Choueiri, MD            
United States, New Jersey
Hunterdon Regional Cancer Center Recruiting
Flemington, New Jersey, United States, 08822
Contact: Myron Bednar, MD     908-788-6461        
Principal Investigator: Myron E Bednar, MD            
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Principal Investigator: Michael K Wong, MD            
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jorge Garcia, MD     216-444-7774        
Principal Investigator: Jorge. Garcia, MD            
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Gary Hudes, MD     215-728-4300        
Principal Investigator: Gary Hudes, MD            
Consultants in Medical Oncology and Hematology Withdrawn
Drexel Hill, Pennsylvania, United States, 19026
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Weijing Sun, MD            
United States, Texas
Arlington Cancer Center Recruiting
Arlington, Texas, United States, 76012
Contact: Anwar Khurshid, MD     817-261-4906        
Principal Investigator: Anwar Khurshid, MD            
United States, Washington
Seattle Cancer Center Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: John Thompson, MD     206-288-1195        
Principal Investigator: John A Thompson, MD            
Sponsors and Collaborators
ImClone Systems
Investigators
Study Chair: Jonathan D Schwartz, MD ImClone Systems
  More Information

Responsible Party: ImClone Systems ( Eric Rowinsky/ Chief Medical Officer )
Study ID Numbers: CP12-0605
Study First Received: August 13, 2007
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00515697  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Disease Progression
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009