Overview

Enhancing Radioiodine Incorporation Into BRAF Mutant Thyroid Cancers With the Combination of Vemurafenib and KTN3379

Status:
Completed
Trial end date:
2016-10-13
Target enrollment:
0
Participant gender:
All
Summary
This is a patient pilot study testing the hypothesis that vemurafenib with the addition of KTN3379 can restore iodine incorporation in BRAF mutant (MUT), radioiodine-refractory (RAIR) thyroid cancer patients.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Celldex Therapeutics
Collaborator:
Memorial Sloan Kettering Cancer Center
Treatments:
Vemurafenib
Criteria
Inclusion Criteria:

- Patients must have histologically or cytologically confirmed thyroid carcinoma of
follicular origin (including papillary, follicular, or poorly differentiated subtypes
and their respective variants).

- Confirmation in a CLIA certified laboratory or in an FDA-approved assay that one of
the patient's thyroid tumors (primary tumor, recurrent tumor, or metastasis) possesses
a BRAF mutation at V600.

- Patients must have measurable disease defined by RECIST criteria 1.1.

- Tumors in previously irradiated fields may be considered measureable if there is
evidence of tumor progression after radiation treatment.

- RAI-refractory disease on structural imaging

- Age ≥ 18 years.

- ECOG performance status ≤ 2

- Patients must have normal organ and marrow function as defined below:

- Absolute neutrophil count (ANC) > 1500/mcl

- Hemoglobin ≥ 9 g/dL

- Platelets ≥ 100,000/mcl

- Albumin ≥ 2.5 g/dL

- Total bilirubin ≤ 1.5x institutional ULN

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x
institutional ULN unless it is related to the primary disease

- Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault
formula) ≥ 50 mL/min OR 24-hour urine creatinine clearance ≥ 50 mL/min

Exclusion Criteria:

- Concomitant malignancies or previous malignancies treated within the past 3 years.
Exception: Patients who have been disease-free for 3 years, patients with a history of
completely resected non-melanoma skin cancer, and/or patients with indolent secondary
malignancies, are eligible.

- Use of other investigational drugs within 28 days preceding the first dose of
vemurafenib on this study.

- Symptomatic or untreated leptomeningeal or brain metastases or spinal cord
compression.

- History or evidence of cardiovascular risk including any of the following:

- Corrected QT (QTc) interval ≥ 450 msec at baseline or history of congenital long
QT syndrome or uncorrectable electrolyte abnormalities. (Patients with well
controlled atrial fibrillation are exempt from this criteria.)

- History of cerebrovascular attack or transient ischemic attack within 6 months
prior to the initiation of therapy on this protocol.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection or psychiatric illness/social situations that would limit
compliance with study requirements.