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Therapeutic Areas: Oncology
Disease Category: Solid Tumors

Trial Information

Phase I study of I-131-CLR1404 in patients with Relapsed or Refractory Advanced Solid Tumors

The purpose of this study is to help us understand how I-131-CLR1404, circulates in your body, how much radiation is delivered to the normal organs of the body, and how much of the study drug clears out of your body through the kidneys and bladder. Over the first 14 days of the study you will have multiple whole body scans, blood and urine collected to help us understand how the drug is distributed and cleared from your body. Your participation in this study is expected to last up to 42 days. You are being asked to take part in this research study because you have been diagnosed with an advanced cancer. I-131-CLR1404 is a radioactive material that is injected into the blood stream. I-131-CLR1404 has shown in prior animal studies that it is attracted to tumor cells and causes a decrease in tumor growth.

Inclusion Criteria:

• 18 years and older
• Male or female
• 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:

• 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
• 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
• Less than 4 weeks since prior major surgery
• Prior allergic reactions to iodine, or other study agents
• 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

Dorie Garcia
City of Hope
Located in:
Duarte, CA 91010
Phone: 626-256-4673 ext. 63021

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