An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Hematologic Malignancies and Poor Prognoses (I-PREDICT Heme)

University of California, San Diego1 site in 1 country13 target enrollmentFebruary 7, 2019

ConditionsHematologic Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hematologic Cancer
Sponsor: University of California, San Diego
Enrollment: 13
Locations: 1
Primary Endpoint: Response rate
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to perform a prospective study that is histology-independent personalized navigation approach to cancer therapy based upon tumor molecular profile as determined by Clinical Laboratory Improvement Amendments (CLIA) certified comprehensive genomic analysis. The molecular mutation profile will then be matched to existing, FDA-approved, targeted agents or to existing clinical trials using investigational agents for treatment of patients with incurable hematologic malignancies for whom no effective standard therapy exists or who have either exhausted or are intolerant of standard options.

Registry

clinicaltrials.gov

Start Date

February 7, 2019

End Date

January 13, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of California, San Diego

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with incurable hematologic malignancies with ≥50% 2-year cancer-associated mortality.
•Patients with relapsed/refractory hematologic malignancies, irrespective of 2-year mortality, who, in the opinion of the investigator, have no treatment option expected to yield significant clinical benefit.
•Patients with a rare tumor histology (i.e., fewer than 6 cases per 100,000 per year) with no approved therapies.
•Patients must have measurable disease for malignancies: defined as at least one lesion that can be accurately measured in at least one dimension with spiral CT scan, PET-CT, MRI, or calipers by clinical exam. Or presence of hematologic abnormalities with or without bone marrow involvement.
•Patients must have evaluable tissue/blood with adequate tumor content/purity for testing as specified by the molecular profiling lab. This will be obtained during the standard of care tumor diagnosis and tumor staging evaluation.
•Age ≥ 18 years.
•ECOG Performance Status 0-
•New York Heart Association (NYHA) Functional Classification I-II.
•Adequate organ function that reasonably allows for safe administration of therapy.
•At the time of treatment, patients should be off other anti-tumor agents for at least 5 half-lives of the agent or 2 weeks from the last day of treatment, whichever is shorter, so long as there is recovery from clinically significant side effects from previous therapy to less than or equal Grade

Exclusion Criteria

•Severe or uncontrolled medical disorder that would, in the investigator's opinion, confound study analyses of treatment response or preclude the patient from safely receiving treatment (i.e. substance abuse or psychiatric illness/social situations that would limit compliance with study requirements).
•Pregnancy, breast-feeding women or any patient with childbearing potential not using adequate pregnancy prevention.
•Inadequate end organ function that would preclude safe administration of anti-neoplastic therapy; including hepatic dysfunction (LFTs \> 5 x normal limit, total bilirubin \> 3 and Cr \> 3 x normal limit or GFR \< 20 cc/min, or symptomatic heart failure (EF \< 20%), except when organ function impairment is a consequence of underlying malignancy and there is a reasonable expectation for improvement following initiation of appropriate therapy.
•Uncontrolled infections or sepsis. Patients with chronic viral infections (including HIV, HBV/HCV) that are controlled with appropriate concurrent therapy are allowed to participate in the study, provided ongoing compliance with antiviral therapy can be reasonably expected throughout the duration of the study. Patients with acute infections must start appropriate anti-microbial therapy and demonstrate stabilization of infection prior to study initiation.