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Solid TumorsPhase 1NCT00925275

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

A Phase 1 study testing I-131-CLR1404 in people with Solid Tumors, run by Cellectar, Inc at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
I-131-CLR1404
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
4 sitesUnited States
Study dates
Jun 2009to Feb 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • City of Hope

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Georgetown University, Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

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

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

Read the 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.

Conditions
Solid Tumors
Being tested
I-131-CLR1404
Keywords
Solid tumors, Refractory, Relapsed, Radiation, Dosimetry, Radiopharmaceutical, Biodistribution, Pharmacokinetics, Cancer, Phase I
Medical subject headings
Recurrence, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-131-CLR1404Drug

    Also called CLR1404, 1404

    Single intravenous injection of 10 millicuries of I-131-CLR1404 given on Day 0

Study groups in NCT00925275
Study groupRoleWhat they receive
DosimetricExperimentalNot described
Receives: Drug: I-131-CLR1404

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 42 days

Secondary outcomes (1)

  1. To determine the safety and pharmacokinetic profile of I-131-CLR1404

    Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00925275
Sponsor's protocol ID
DCL-08-001
Status last verified
Apr 2010
First submitted
18 Jun 2009
Last updated
4 May 2010
Results posted
No
Data monitoring committee
No

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.

    PubMed 25402488

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing I-131-CLR1404 in people with Solid Tumors, run by Cellectar, Inc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00925275, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2010.

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