Molecular Analysis in Tissue Samples From Patients With Advanced or Metastatic Neuroendocrine Tumors

NCT02092714 | Unknown DMC

• 4 other identifiers: CGI-061NCI-2013-0195013-040P30CA006927
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot research trial studies molecular analysis in tissue samples from patients with advanced or metastatic neuroendocrine tumors. Studying samples of tissue from patients with neuroendocrine tumors in the lab may help doctors identify mutations to classify disease and plan the best treatment.

Conditions

Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• Feasibility, defined as the true proportion of patients whose CancerCode sequencing results in the identification of at least 1 actionable mutation

  Up to 3 years

Secondary Outcomes (5)

• Response rate, defined as at least a 30% decrease in target lesions when measureable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

  Up to 3 years

• Progression-free survival

  Up to 3 years

• Overall survival

  Up to 3 years

• Proportion of Arm B patients whose therapy is changed as a result of physician access to CancerCode results

  Up to 3 years

• Proportion of Arm B patients for whom a local protocol offers a potential therapeutic option based on CancerCode results

  Up to 3 years

Other Outcomes (5)

• Mutations occurring in greater than or equal to 10% of patients

  Up to 3 years

• Mutations in the mTOR pathway

  Up to 3 years

• Prognostic value of MGMT status among patients on alkylating agents

  Up to 3 years

Study Arms (1)

Ancillary-correlative (molecular analysis)

Previously collected tissue samples are analyzed via mutational sequencing and immunohistochemistry.

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Ancillary-correlative (molecular analysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with incurable neuroendocrine tumors, excluding small cell/large cell lung cancers and Merkel cell carcinomas

You may qualify if:

• Pathologically or cytologically confirmed neuroendocrine tumor which is metastatic, locally advanced or otherwise incurable (of any grade or primary site, excluding small cell lung cancers, large cell lung cancers, and Merkel cell carcinomas)
• Evaluable disease by radiographic imaging
• Adequate available tumor tissue (formalin-fixed paraffin-embedded \[FFPE\] tissue or cytologic material) for sequencing (containing \> 50% tumor cellularity by histopathology) or consent to tumoral biopsy for fresh tissue; adequacy will be determined by our pathology department, under supervision of Dr. Gustafson
• Ability to understand and willingness to sign a written informed consent and Health Information Portability and Accountability Act (HIPAA) consent document
• Life expectancy of \>= 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2

You may not qualify if:

• Localized neuroendocrine tumor for which the patient is eligible for a potentially curative surgical intervention
• Primary diagnosis of pulmonary small cell carcinoma, pulmonary large cell carcinoma or Merkel cell carcinoma
• Inability to provide informed consent
• Inadequate tissue available for genetic testing
• Any secondary active malignancy, excluding non-melanoma skin cancers; if the patient's prognosis will be primarily determined by their neuroendocrine tumor, the secondary malignancy is to be discounted

Sponsors & Collaborators

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

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and tumor tissue

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Paul Engstrom

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: October 16, 2013
• Primary Completion: April 11, 2018
• Study Completion: November 16, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (1)