An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children, Adolescents, and Young Adults With Select Solid Tumors, Lymphoma, and Malignant Brain Tumors

Who is this study for? Children, adolescents, and young adults with select solid tumors, lymphoma, and malignant brain tumors
What treatments are being studied? CLR 131
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment options with curative potential.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 25
Healthy Volunteers: No
View:

• All Patients

• Previously confirmed (histologically or cytologically) pediatric solid tumor (e.g., neuroblastoma, sarcoma), lymphoma (including Hodgkin's lymphoma), or malignant brain tumors that are clinically or radiographically suspected to be relapsed, refractory, or recurrent for which there are no standard treatment options with curative potential. Note: patients with diffuse intrinsic pontine glioma (DIPG) may enroll without histological or cytological confirmation.

• ≥ 2 years of age and ≤ 25 years of age at time of consent/assent

• If ≥ age 16 years, Karnofsky performance status of ≥ 60. If < age 16 years, Lansky performance status ≥ 60

• Platelets ≥ 75,000/µL (last transfusion, if any, must be at least 1 week prior to study registration, and, unless deemed medically necessary, no transfusions are allowed between registration and dosing)

• Absolute neutrophil count ≥ 750/µL

• Hemoglobin ≥ 8 g/dL (last transfusion must be at least 1 week prior to study registration, and, unless deemed medically necessary, no transfusions are allowed between registration and dosing)

• Using the bedside Schwartz formula, estimated GFR (creatinine clearance) > 60 ml/min/1.73m2

• Alanine aminotransferase < 3 × ULN

• Bilirubin < 2 × ULN

• Patients who have undergone autologous or allogeneic bone marrow transplant must be at least 3 months from transplant.

• Patients enrolling at total dose levels > 30 millicurie (mCi)/m2 must have availability or ability to collect an autologous hematopoietic stem cell back-up product prior to CLR 131 administration. At minimum, 2 x 10^6/kg cryopreserved CD34+ cells must be available.

• Patient or his or her legal representative is judged by the Investigator to have the initiative and means to be compliant with the protocol.

• Patients with Pediatric Solid Tumor or Lymphoma

• At least 1 measurable lesion with longest diameter of at least 10 mm. Patients with a lesion(s) that are determined to be Metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) positive may be enrolled at the investigator's discretion, even if not associated with a measurable lesion of at least 10 mm. Patients with neuroblastoma who have detectable disease may enroll provided they meet the requirements of the International Neuroblastoma Response Criteria.

• Patients with known brain metastases must have completed any radiotherapy or systemic treatments for brain metastases prior to enrollment; by investigator assessment be considered stable with no new signs or symptoms for at least 1 month, and on a stable dose of steroids (unchanged for three weeks prior to registration or on a steroid tapering regimen).

• Patients with Recurrent or Refractory Brain Tumors

• At least 1 measurable lesion with longest diameter of at least 10 mm on any imaging sequence.

• Patients with previously known neurological deficits must be clinically stable at time of enrollment and able to complete all study related procedures. Patients with documented or newly diagnosed neurological deficits will be enrolled at the investigator's discretion.

• If patient receives steroids for neurological symptom control, the dose must be stable (unchanged for three weeks prior to registration) or on a steroid tapering regimen. Initiation of steroids per routine care immediately prior to CLR 131 dosing is acceptable.

Locations
United States
California
Lucile Packard Children's Hospital
Recruiting
Palo Alto
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Ohio
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Texas
Texas Children's Hospital
Recruiting
Houston
Wisconsin
University of Wisconsin Hospital and Clinics
Recruiting
Madison
Other Locations
Australia
Children's Hospital at Westmead
Recruiting
Westmead
Canada
Hospital for Sick Children
Recruiting
Toronto
Contact Information
Primary
Kate Oliver
clinical@cellectar.com
608-327-8125
Time Frame
Start Date: April 30, 2019
Estimated Completion Date: December 2024
Participants
Target number of participants: 30
Treatments
Experimental: CLR 131
CLR 131 intravenous administration
Sponsors
Leads: Cellectar Biosciences, Inc.

This content was sourced from clinicaltrials.gov

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