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

Cellectar, Inc4 sites in 1 country9 target enrollmentJune 2009

ConditionsSolid Tumors

InterventionsI-131-CLR1404

DrugsI-131-CLR1404

Overview

Phase: Phase 1
Intervention: I-131-CLR1404
Conditions: Solid Tumors
Sponsor: Cellectar, Inc
Enrollment: 9
Locations: 4
Primary Endpoint: 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
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

February 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cellectar, Inc

Eligibility 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:

Arms & Interventions

Dosimetric

Intervention: I-131-CLR1404

Outcomes

Primary Outcomes

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