Next Generation Sequence Target-Directed Therapy in Treating Patients With Cancer

NCT02132845 | Completed

• 3 other identifiers: CGI-065NCI-2014-00716P30CA006927
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial studies how well next generation sequence target-directed therapy works in treating patients with cancer. Next generation sequencing is a test that screens for mutations to cancer related genes. Target-directed therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells that may have less harm to normal cells. Next generation sequencing may help identify these specific types of cancer cells.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Overall (composite) response rate

  The overall (composite) response rate will be defined by tumor response rate according to RECIST 1.1 or by tumor marker response for patients without measurable disease defined by RECIST 1.1. Tumor marker response will be quantified as a 50% reduction in the marker of interest, when compared to baseline, without any radiographic evidence of progressive disease.

  Up to 2 years

Secondary Outcomes (5)

• Progression free survival

  Time from randomization to time of progression or death, whichever occurs first, assessed at 4 months

• Mutation rate

  Up to 2 years

• Actionable mutation rate

  Up to 2 years

• Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

  Up to 2 years

• Median overall survival

  Up to 2 years

Other Outcomes (4)

• Targeted agent rate

  Up to 2 years

• Available protocol rate

  Up to 2 years

• Protocol enrollment rate

  Up to 2 years

Study Arms (2)

Arm A (standard of care therapy)

ACTIVE COMPARATOR

Patients undergo collection of tissue and blood samples for analysis via next generation sequencing. Patients receive standard of care therapy based on the discretion of the treating physician.

Other: cytology specimen collection procedure; Procedure: therapeutic procedure; Other: laboratory biomarker analysis

Arm B (target-directed therapy)

EXPERIMENTAL

Patients undergo collection of tissue and blood samples for analysis via next generation sequencing. Based on the results of the next generation sequencing, patients receive target-directed therapy.

Other: cytology specimen collection procedure; Drug: targeted therapy; Other: laboratory biomarker analysis

Interventions

cytology specimen collection procedure OTHER

Undergo collection of tissue and blood samples

Also known as: cytologic sampling

Arm A (standard of care therapy); Arm B (target-directed therapy)

targeted therapy DRUG

Receive target-directed therapy

Arm B (target-directed therapy)

therapeutic procedure PROCEDURE

Receive standard of care therapy

Also known as: Therapeutic Interventions, Therapeutic Method, Therapeutic Technique, Therapy, TX

Arm A (standard of care therapy)

laboratory biomarker analysis OTHER

Correlative studies

Arm A (standard of care therapy); Arm B (target-directed therapy)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed cancer
• Patients must have evaluable disease; measureable disease is not required; however, if measurable disease is present, it is defined as at least one lesion that can be accurately measured in at least one dimension in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v.) 1.1; furthermore, if only evaluable disease is present, a relevant tumor marker (per investigator discretion) must be \>= 2 times upper limit of normal (ULN) at baseline, and can be used as a response indicator
• Patients must be considered good candidates for a phase 1 trial and the treating physician must intend to enroll the patient on a phase 1 clinical protocol, if possible; patients are not required to have progressed on their last line of therapy prior to enrollment
• Other clinical trials are also acceptable; for example, an applicable phase 2 or phase 3 trial may exist for which the patient would be eligible and for which available information (inclusive of next generation sequencing \[NGS\]) would be relevant to such enrollment; regardless, the pertinent point is that it is the intent of the physician to use NGS data, to the degree possible, to select appropriate therapy, when selecting patients for this trial
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Absolute neutrophil count \> 1,000/mcL
• Platelets \> 80,000/mcL
• Total bilirubin =\< 1.5 times ULN and stable X 1 month
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) (serum glutamic oxaloacetic transaminase \[SGOT\]/serum glutamate pyruvate transaminase \[SGPT\]) \< 3 times ULN (if liver metastasis is present then =\< 5 X ULN)
• Serum creatinine =\< 1.5 X ULN and stable X 1 month OR creatinine clearance \>= 60 Ml/min/1.73 m\^2
• Estimated life expectancy of \>= 3 months
• Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

You may not qualify if:

• Patients with more than one type of active malignancy; an active malignancy is defined as one that is being treated with therapeutic intent and for which survival may be impacted, within 3 years of enrollment
• Patients with known active brain metastases; patients with a history of treated brain metastasis are eligible if the patient is off systemic steroids and there are no clinical indications of central nervous system (CNS) progression for a least 1 month; patients with glioblastoma multiforme are eligible if the above criteria are otherwise met; note: many clinical trials do not allow enrollment of such patients; if the physician, in good conscience, feels that applicable protocols for their patient do exist, enrollment onto this trial is acceptable, assuming other eligibility criteria are met
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Coal Tar; Therapeutics

Intervention Hierarchy (Ancestors)

Tars; Complex Mixtures

Study Officials

• Anthony Olszanski

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: March 17, 2016
• Primary Completion: May 10, 2018
• Study Completion: May 10, 2018
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

US (1)