NCT00925275

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 4, 2010

Status Verified

April 1, 2010

Enrollment Period

8 months

First QC Date

June 18, 2009

Last Update Submit

April 30, 2010

Conditions

Solid Tumors

Keywords

Solid tumorsRefractoryRelapsedRadiationDosimetryRadiopharmaceuticalBiodistributionPharmacokineticsCancerPhase I

Outcome Measures

Primary Outcomes (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

    42 days

Secondary Outcomes (1)

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

    42 days

Study Arms (1)

Dosimetric

EXPERIMENTAL
Drug: I-131-CLR1404

Interventions

I-131-CLR1404DRUG

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

Also known as: CLR1404, 1404
Dosimetric

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

City of Hope

Duarte, California, 91010, United States

Location

Georgetown University, Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 25402488DERIVED

MeSH Terms

Conditions

RecurrenceNeoplasms

Interventions

CLR1404lortalamine

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Cellectar, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 22, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

May 4, 2010

Record last verified: 2010-04

Locations

US(4)