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

Sponsor

Cellectar, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00925275

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: I-131-CLR1404	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dosimetric	Drug: I-131-CLR1404 Single intravenous injection of 10 millicuries of I-131-CLR1404 given on Day 0 Other Names: CLR1404 1404

Arm

Intervention/Treatment

Experimental: Dosimetric

Drug: I-131-CLR1404

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

Other Names:

CLR1404

1404

Outcome Measures

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 [42 days]

Secondary Outcome Measures

To determine the safety and pharmacokinetic profile of I-131-CLR1404 [42 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	Georgetown University, Lombardi Cancer Center	Washington	District of Columbia	United States	20007
3	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21287
4	Duke University Medical Center	Durham	North Carolina	United States	27710