Malignant NeoplasmNCT02132845
Next Generation Sequence Target-Directed Therapy in Treating Patients With Cancer
A study testing cytology specimen collection procedure, targeted therapy and therapeutic procedure in people with Malignant Neoplasm, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- cytology specimen collection procedure, targeted therapy and therapeutic procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2016to 10 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Prospective Randomized Trial Comparing the Effectiveness of Physician Discretion Guided Therapy Versus Physician Discretion Guided Plus Next-Generation Sequence Directed Therapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Overall (composite) response rate (ORR).
SECONDARY OBJECTIVES:
- 4-month progression free survival (PFS). II. Mutation rate. III. Adverse event rate/severity. IV. Overall survival.
TERTIARY OBJECTIVES:
- Targeted agent rate. II. Available protocol rate. III. Protocol enrollment rate. IV. Disease site influence.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: 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.
ARM B: 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.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
- Conditions
- Malignant Neoplasm
- Being tested
- cytology specimen collection procedure, targeted therapy, therapeutic procedure, laboratory biomarker analysis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytology specimen collection procedureOther
Also called cytologic sampling
Undergo collection of tissue and blood samples
targeted therapyDrug
Receive target-directed therapy
therapeutic procedureProcedure or surgery
Also called Therapeutic Interventions, Therapeutic Method, Therapeutic Technique, Therapy
Receive standard of care therapy
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: cytology specimen collection procedure; Drug: targeted therapy; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (5)
Progression free survival
The percentage of patients progression free and alive will be estimated using the method of Kaplan and Meier. PFS in control will be compared to those in the experimental arm using log-rank tests.
Measured: Time from randomization to time of progression or death, whichever occurs first, assessed at 4 months
Mutation rate
Mutation rate, defined as the percentage of patients with >= 1 mutation identified will be estimated using the method of Pearson and Clopper as binomial proportions. 95% confidence intervals will be provided for these proportions.
Measured: Up to 2 years
Actionable mutation rate
The percentage of patients with "actionable" mutation rate will be estimated using the method of Pearson and Clopper as binomial proportions. 95% confidence intervals will be provided for these proportions.
Measured: Up to 2 years
Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
The rate of adverse events will be estimated using the method of Pearson and Clopper as binomial proportions. 95% confidence intervals will be provided for these proportions. Adverse events will be tabulated according to severity.
Measured: Up to 2 years
Median overall survival
OS will be estimated using the method of Kaplan and Meier. OS in control will be compared to those in the experimental arm using log-rank tests.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study start17 Mar 2016
- Primary completion10 May 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anthony Olszanski, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132845
- Sponsor's protocol ID
- CGI-065
- Other IDs
- NCI-2014-00716, CGI-065, P30CA006927
- Status last verified
- Feb 2021
- First submitted
- 6 May 2014
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing the Effectiveness of Physician Discretion Guided Therapy Versus Physician Discretion Guided Plus Next-Generation Sequence Directed Therapy
- ClinicalTrials.gov ID
- NCT02132845
- Acronym / sponsor ID
- CGI-065
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Overall (composite) response rate (ORR).
SECONDARY OBJECTIVES:
- 4-month progression free survival (PFS). II. Mutation rate. III. Adverse event rate/severity. IV. Overall survival.
TERTIARY OBJECTIVES:
- Targeted agent rate. II. Available protocol rate. III. Protocol enrollment rate. IV. Disease site influence.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: 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.
ARM B: 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.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (standard of care therapy) | Active comparator | Other: cytology specimen collection procedure, Procedure: therapeutic procedure, Other: laboratory biomarker analysisPatients 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. |
| Arm B (target-directed therapy) | Experimental | Other: cytology specimen collection procedure, Drug: targeted therapy, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Absolute neutrophil count > 1,000/mcL
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytology specimen collection procedureAlso: cytologic samplingUndergo collection of tissue and blood samples | Other | Arm A (standard of care therapy), Arm B (target-directed therapy) |
| targeted therapyReceive target-directed therapy | Drug | Arm B (target-directed therapy) |
| therapeutic procedureAlso: Therapeutic Interventions, Therapeutic Method, Therapeutic Technique, TherapyReceive standard of care therapy | Procedure or surgery | Arm A (standard of care therapy) |
| laboratory biomarker analysisCorrelative studies | Other | Arm A (standard of care therapy), Arm B (target-directed therapy) |
Primary outcome
Overall (composite) response rate
Time frame: Up to 2 years
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.
5 secondary outcomes
Progression free survival
Time frame: Time from randomization to time of progression or death, whichever occurs first, assessed at 4 months
Mutation rate
Time frame: Up to 2 years
Actionable mutation rate
Time frame: Up to 2 years
Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 2 years
Median overall survival
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Olszanski principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cytology specimen collection procedure, targeted therapy and therapeutic procedure in people with Malignant Neoplasm, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall (composite) response rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.