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Trial record 3 of 9 for:    clr1404

Dosimetry Study of I-131-CLR1404 in Patients With Relapsed or Refractory Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00925275
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : May 4, 2010
Sponsor:
Information provided by:
Cellectar, Inc

Tracking Information
First Submitted Date  ICMJE June 18, 2009
First Posted Date  ICMJE June 22, 2009
Last Update Posted Date May 4, 2010
Study Start Date  ICMJE June 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2009)
Calculate whole body and organ radiation dosimetry of I-131-CLR1404 to determine the millicurie dose which is expected to deliver 35-40 centigray of radiation to bone marrow [ Time Frame: 42 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2009)
To determine the safety and pharmacokinetic profile of I-131-CLR1404 [ Time Frame: 42 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dosimetry Study of I-131-CLR1404 in Patients With Relapsed or Refractory Advanced Solid Tumors
Official Title  ICMJE A Phase I, Multi-Center, Open-Label, Dosimetry Study of I-131-CLR1404 in Patients With Relapsed or Refractory Advanced Solid Tumors Who Have Failed Standard Therapy or for Whom No Standard Therapy Exists
Brief Summary The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of I-131-CLR1404.
Detailed Description I-131-CLR1404 is a small-molecule, phospholipid ether analog that combines lipid-like properties with a cancer therapeutic beta-emitting radioisotope. Cellectar believes that this compound will benefit individuals with cancer due to its selective retention and accumulation in malignant cells versus nonmalignant cells. Preclinical experiments have demonstrated that I-131-CLR1404 significantly slows malignant tumor growth in several mouse tumor models.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Solid Tumors
Intervention  ICMJE Drug: I-131-CLR1404
Single intravenous injection of 10 millicuries of I-131-CLR1404 given on Day 0
Other Names:
  • CLR1404
  • 1404
Study Arms  ICMJE Experimental: Dosimetric
Intervention: Drug: I-131-CLR1404
Publications * Grudzinski JJ, Titz B, Kozak K, Clarke W, Allen E, Trembath L, Stabin M, Marshall J, Cho SY, Wong TZ, Mortimer J, Weichert JP. A phase 1 study of 131I-CLR1404 in patients with relapsed or refractory advanced solid tumors: dosimetry, biodistribution, pharmacokinetics, and safety. PLoS One. 2014 Nov 17;9(11):e111652. doi: 10.1371/journal.pone.0111652. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 19, 2009)
9
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Relapsed or refractory advanced solid tumor(s) and have exhausted standard treatment options or no standard therapy exists
  • Must have a sufficient window of time to complete the washout period, dosimetry data acquisition and the follow up safety assessment period
  • ECOG performance status of 0 or 1 and estimated life expectancy of ≥ 4 months
  • 18 years or older
  • Must be compliant with the protocol and be within geographical proximity to make the required study visits
  • Have the ability to read, understand and provide written informed consent
  • Patients with brain metastasis are acceptable if the clinical condition has been stable for at least one month
  • Female patients of childbearing potential must have a negative serum pregnancy test within 24 hours of start of treatment
  • Must agree to use an effective method of contraception during the study and for 90 days following the last dose of study drug

Exclusion Criteria:

  • Patient or physician plans concomitant chemotherapy, therapeutic radiation treatment, and/or biological treatment for cancer including immunotherapy while on study
  • More than 25% of the total bone marrow irradiated
  • Diffuse lung disease or interstitial spread of carcinoma
  • Bladder or rectum is within a prior radiation therapy field and a dose of greater than 45 Gy was administered
  • Total therapeutic radiation dose in the past year in excess of 25 Gy to the kidney, 45 Gy to brain, 45 Gy to stomach, 18 Gy to lung, or 25 Gy to liver
  • Prior total-body irradiation
  • Extradural tumor in contact with the spinal cord, or tumor located where swelling in response to therapy may impinge upon the spinal cord
  • Prior radiation therapy or chemotherapy within 2 weeks of the start of the study
  • Active medical condition(s) or organ disease(s) that may either compromise patient safety or interfere with the safety and/or outcome evaluation of the study drug
  • Laboratory values ≤ 7 days:

    • WBC < 3000/µL
    • Absolute neutrophil count < 1500/µL
    • Platelets < 150,000/µL
    • Hemoglobin ≤ 11.0 gm/dL
    • Total bilirubin > 1.5 x upper limit of normal for age
    • SGOT or SGPT > 3 x upper limit of normal for age if no liver metastases or > 5 x upper limit of normal for age in the presence of liver metastases
    • Serum creatinine > 1.5 x upper limit of normal for age
    • INR ≥ 2.0
  • Investigational drug, investigational biologic, or investigational therapeutic device within 30 days of initiating study drug
  • Severely marrow toxic drugs (e.g. nitrosoureas, mitomycin)
  • Prior treatment with Iodine-131 in the past five years
  • Concurrent hemodialysis
  • Blood transfusions within 60 days of study start
  • Hematopoietic growth factor therapy within 60 days of study start
  • Prior stem cell transplantation
  • Clinically evident ascites or with peritoneal carcinomatosis
  • Clinically significant cardiac co-morbidities including: CHF, a LVEF< 40%, unstable angina pectoris, serious cardiac arrhythmia requiring medication or a pacemaker, myocardial infarction within the past six months
  • Clinically significant pulmonary impairment defined as an SaO2 on room air of 93% or less
  • Concurrent or recent use of thrombolytic agents, or full-dose anticoagulants
  • Uncontrolled hypertension or patients with uncontrolled diabetes
  • Grade II-IV peripheral vascular disease or peripheral vascular surgery within the past year
  • Less than 4 weeks since prior major surgery
  • Known positive for HIV, Hepatitis C (active, previously treated or both), or is Hepatitis B core antigen positive
  • Concurrent chronic use of aspirin (325 mg/day or more)
  • Pregnant or lactating
  • Patients with colostomy/ileostomy
  • Poor venous access
  • Prior allergic reactions to iodine, or other study agents
  • Significant traumatic injury within the past 4 weeks
  • Ongoing or active infection requiring antibiotics or with a fever >38.1°C (>101° F) within 3 days of the first scheduled day of dosing
  • Patients who are hospitalized
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00925275
Other Study ID Numbers  ICMJE DCL-08-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director Clinical Operations, Cellectar, Inc.
Study Sponsor  ICMJE Cellectar, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Cellectar, Inc
PRS Account Cellectar, Inc
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP