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

This study has been completed.
Sponsor:
Information provided by:
Cellectar, Inc
ClinicalTrials.gov Identifier:
NCT00925275
First received: June 18, 2009
Last updated: April 30, 2010
Last verified: April 2010
  Purpose

The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of I-131-CLR1404.


Condition Intervention Phase
Solid Tumors
Drug: I-131-CLR1404
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cellectar, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the safety and pharmacokinetic profile of I-131-CLR1404 [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 9
Study Start Date: June 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosimetric Drug: I-131-CLR1404
Single intravenous injection of 10 millicuries of I-131-CLR1404 given on Day 0
Other Names:
  • CLR1404
  • 1404

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925275

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
United States, District of Columbia
Georgetown University, Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Cellectar, Inc
Investigators
Study Director: Medical Monitor Cellectar, Inc
  More Information

No publications provided

Responsible Party: Director Clinical Operations, Cellectar, Inc.
ClinicalTrials.gov Identifier: NCT00925275     History of Changes
Other Study ID Numbers: DCL-08-001
Study First Received: June 18, 2009
Last Updated: April 30, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cellectar, Inc:
Solid tumors
Refractory
Relapsed
Radiation
Dosimetry
Radiopharmaceutical
Biodistribution
Pharmacokinetics
Cancer
Phase I

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014