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

April 30, 2010 updated by: Cellectar, Inc

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University, Lombardi Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University School Of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dosimetric
Drug: I-131-CLR1404
Single intravenous injection of 10 millicuries of I-131-CLR1404 given on Day 0
Other Names:
  • 1404
  • CLR1404

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
42 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To determine the safety and pharmacokinetic profile of I-131-CLR1404
Time Frame: 42 days
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cellectar, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Monitor, Cellectar, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCL-08-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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