Status:
COMPLETED
Dose Escalation Study of I-131-CLR1404 in Subjects With Cancer That Does Not Respond to Treatment or Has Returned
Lead Sponsor:
Cellectar Biosciences, Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the recommended dose of I-131-CLR1404, a radiolabeled therapy compound, for treating subjects with cancer that does not respond to treatment or has returned. ...
Eligibility Criteria
Inclusion
- Relapsed or refractory advanced solid malignancy or choice not to pursue standard treatment. Tumor types allowed: non-small cell lung, triple negative breast, soft tissue sarcoma, colorectal, gastric, esophageal, prostate, ovarian cancer
- ≥ 1 lesion that qualifies as a "target lesion" based on RECIST 1.1
- Ambulatory w/ECOG performance status 0 to 2 and estimated life expectancy ≥ 4 mo.
- 18 years or older
- Judged by Investigator to have initiative and means to be compliant with protocol and w/n geographical proximity to make required study visits
- Ability to read, understand and provide written informed consent for initiation of any study related procedures (subject or legal representative)
- Brain metastasis acceptable if clinical condition stable ≥ 1 mo. Subjects with brain metastasis requiring steroids must have been on a stable or tapering dose of corticosteroids ≥ 1 mo. prior to enrollment
- Negative serum pregnancy test w/n 24 hours of enrollment (Female subjects of childbearing potential)
- Agreement to use effective contraception method (oral contraceptives, double-barrier methods, intrauterine device, Norplant, Depo-Provera) during study and 90 days following last dose
Exclusion
- Subject or physician plans concomitant chemotherapy, therapeutic radiation and/or biological treatment for cancer including immunotherapy while on study. Localized palliative radiation therapy for bone pain allowed if clinically indicated. Ongoing hormonal therapy may be continued
- Received \> 3 previous cytotoxic chemotherapy regimens
- Received \> 25% of total bone marrow irradiated, total body or hemi-body irradiation or prior radioisotope therapy (except for benign thyroid disease)
- Diffuse lung disease or interstitial spread of carcinoma
- Prior radiation therapy or chemotherapy w/n 4 weeks of study start
- Extradural tumor in contact with spinal cord or tumor located where swelling in response to therapy may impinge upon spinal cord
- Other active medical condition or organ disease that may compromise safety or interfere with safety and/or outcome evaluation of study drug
- Laboratory abnormalities, including but not limited to: WBC \< 3000/uL, Absolute neutrophil count \< 1500/uL, Platelets \< 150,000/uL, Hemoglobin ≤ 9.0 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, 2+ proteinuria or casts indicative of intrinsic renal disease
- Treatment with investigational drug, investigational biologic, or investigational therapeutic device w/n 28 days of initiating study treatment
- Received severely marrow toxic drugs (eg nitrosoureas, mitomycin)
- Received blood transfusions or hematopoietic growth factor therapy w/n 30 days of study start
- Received prior stem cell transplantation
- Clinically significant cardiac co-morbidities including congestive heart failure (New York Heart Association class III-IV heart disease), left ventricular ejection fraction \< 40%, unstable angina pectoris, serious cardiac arrhythmia requiring medication or pacemaker, myocardial infarction within past 6 months
- Concurrent or recent (w/n 1 month) use of thrombolytic agents or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters). Therapy with low-molecular weight heparin is acceptable as long as INR \< 2.0
- Uncontrolled hypertension as defined by systolic blood pressure \> 150 mm/Hg, diastolic blood pressure \> 100 mm/Hg or uncontrolled diabetes that would compromise subject safety or interfere with safety and/or outcome evaluation of study drug
- Grade II-IV peripheral vascular disease or peripheral vascular surgery w/n past year
- Major surgery w/n 4 wks. of enrollment
- Poor venous access and unable to receive study drug into a peripheral venous catheter
- Significant traumatic injury w/n past 4 wks.
- Ongoing or active infection requiring antibiotics or with fever \>38.1º C (\>101º F) w/n 3 days of first scheduled day of dosing
- Receiving concurrent hemodialysis or peritoneal dialysis
- Known positive for HIV, Hepatitis C (active, previously treated or both) or is Hepatitis B core antigen positive
- Pregnant or lactating
- Hospitalized
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01495663
Start Date
December 1 2011
End Date
January 1 2014
Last Update
February 26 2015
Active Locations (3)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007-2113
3
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792