Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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. The identified recommended dose in this study will be used as the optimal dose of I-131-CLR1404 in subsequent clinical trials conducted for later phase clinical development.

Subjects who meet study entry criteria will receive I-131-CLR1404. For each subject, the study will be conducted in two phases, dosimetric and therapy. In the dosimetric phase, subjects will receive one 5 mCi dose of the study drug and undergo whole body imaging on on the day of infusion and on post-infusion days 1, 2, 3, and 6 for assessment of biodistribution of I-131-CLR1404. If normal and expected biodistribution are demonstrated, the subject will begin the therapy phase. In the therapy phase, the first cohort of subjects will receive a dose of 12.5 mCi/m2. Dose escalation in subsequent cohorts will initially be in increments of 12.5 mCi/m2. Subjects will be followed and observed for unacceptable toxicity through 56 days after the therapy dose infusion with follow-up for up to one year.

All subjects will be prescribed thyroid protection medication to be taken 24 hours prior to injection of the dosimetric dose, and continuing for 14 days after the administration of the therapy dose.

Eligibility Criteria

Inclusion Criteria:

• 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

• At least one lesion that qualifies as a "target lesion" based on RECIST 1.1

• Ambulatory with ECOG performance status of 0 to 2 and an estimated life expectancy of at least 4 months

• 18 years of age or older

• Judged by Investigator to have initiative and means to be compliant with protocol and within 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 are acceptable if clinical condition has been stable for at least 1 month. Subjects with brain metastasis who require steroids must have been on a stable or tapering dose of corticosteroids for at least 1 month prior to enrollment

• Negative serum pregnancy test within 24 hours of enrollment (Female subjects of childbearing potential)

• Agreement to use an effective method of contraception (oral contraceptives, double-barrier methods such as condom and diaphragm, intrauterine device, Norplant, Depo-Provera) during the study and for 90 days following last dose of study drug

Exclusion Criteria:

• 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 is allowed during study period if clinically indicated. Ongoing hormonal therapy may be continued

• Received more than three previous cytotoxic chemotherapy regimens

• Received more than 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 within 4 weeks of start of study

• Extradural tumor in contact with spinal cord or tumor located where swelling in response to therapy may impinge upon spinal cord

• Another active medical condition(s) or organ disease(s) that may compromise subject 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 within 28 days of initiating study treatment

• Received severely marrow toxic drugs (e.g. nitrosoureas, mitomycin)

• Received blood transfusions or hematopoietic growth factor therapy within 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 (within 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 within past year

• Major surgery within 4 weeks of enrollment

• Poor venous access and unable to receive study drug into a peripheral venous catheter

• Significant traumatic injury within past 4 weeks

• Ongoing or active infection requiring antibiotics or with fever >38.1º C (>101º F) within 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Novelos Therapeutics, Incorporated

Glenn Liu

Principal Investigator

Jill Irwin		Ph: 608-327-8126
		Email: jirwin@novelos.com

U.S.A.
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Joanne Mortimer, M.D., FACP	Principal Investigator
District of Columbia
	Washington, DC
	Georgetown University Hospital
		Michael Pishvaian, M.D.	Principal Investigator
Wisconsin
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Glen Liu, M.D.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01495663
Information obtained from ClinicalTrials.gov on January 28, 2013

Back to Top