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

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

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

Key facts

Study ID

NCT00925275

Run by

Cellectar, Inc

People needed

9

Starts

2009-06-01

Expected to finish

2010-02-01

Last updated by the study team

2010-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States
• Georgetown University, Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.