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Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy in Patients With Advanced Malignancies


N/A
18 Years
N/A
Open (Enrolling)
Both
Hematologic Neoplasms

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Trial Information

Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy in Patients With Advanced Malignancies


This study will be a companion study to existing phase I clinical trial treatment studies.
It is being done to determine the feasibility of obtaining tumor tissue for genomic
analysis. Patient will be offered enrollment into this trial at the time that they are being
considered for participation in a phase I treatment trial. After consenting for this study,
patients will undergo a fresh tumor biopsy and collection of research blood samples.
Archived tumor specimens will also be obtained and analyzed. At the time of disease
progression, fresh tumor biopsies and blood samples will be collected in patients who have
evaluable pre-biopsy specimens and who are eligible to be screened for another study. This
will be informative to evaluate the mechanisms of resistance to that agent.


Inclusion Criteria:



- Have an advanced solid or hematological malignancy that is resistant to standard
therapy or for which no standard therapy is available.

- Being considered for early phase clinical trials in which an investigational agent is
used either alone or in combination with chemotherapy or radiation. Patients who
decline to enroll in this companion study will not be denied participation in the
primary treatment protocols. Patients who are participating in phase I-III clinical
treatment trials in which a tissue biopsy is already required, or patients who have
standard of care tumor biopsies or procedures planned, e.g. to confirm metastatic
recurrence or palliative resection of tumor, would also be eligible for participation
in this trial.

- Have a primary or metastatic tumor lesion that is amenable to biopsy or resection.
Patients whose tumors cannot be safely biopsied by fine needle aspiration or core
needle biopsy are still eligible to participate in the aspects of the trial involving
collection of archival tumor and blood.

- Age ≥ 18 years old.

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

- Life expectancy > 2 months.

- Creatinine clearance ≥ 50 mL/min (applicable only if undergoing CT-guided biopsy that
requires IV contrast enhancement).

- For patients with advanced solid malignancies, adequate hematologic function as
defined by an absolute neutrophil count (ANC) ≥1,000/mm^3, platelet count ≥
50,000/mm^3, white blood cell count (WBC) ≥ 3,000/ mm^3, and hemoglobin ≥ 8 g/dL.

- International normalized ratio (INR) ≤ 1.5. Patients on warfarin therapy must be
able to safely withhold warfarin or be bridged with low-molecular weight therapy and
demonstrate an INR ≤ 1.5 prior to the biopsy.

- Able to understand and willingness to sign a written informed consent document,
agreeing to baseline and/or post-treatment tumor biopsies and/or blood collection.

- Patients who do not qualify for tumor biopsy due to laboratory abnormalities are
still eligible to participate in the aspects of the trial involving collection of
blood.

Exclusion Criteria:

- Have a known or suspected bleeding disorder that in the investigator's opinion would
increase the risk of bleeding from a biopsy procedure. Patients who do not qualify
for tumor biopsy due to a known or suspected bleeding disorder are still eligible to
participate in the aspects of the trial involving collection of archival tumor and
blood.

- Patients will be excluded if their participation in this study for pre-treatment
biopsy, in the investigator's opinion, will significantly delay enrollment and
treatment on clinical trial. Patients who are waiting for slot availability or who
are undergoing a required washout from prior therapy are eligible to enroll.

- Patients with active uncontrolled bacterial, fungal or viral infection.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, or in
the judgment of the investigator would make the patient inappropriate for entry into
the study.

- Pregnant or breast feeding.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Molecularly characterizing pre-treatment tumor biopsies

Outcome Description:

As this is an exploratory, pilot feasibility study, data will be analyzed primarily with descriptive statistics. It is anticipated that this study will take up to 24-36 months to complete accrual of up to 50 patients.

Outcome Time Frame:

Up to 24-36 months

Safety Issue:

No

Principal Investigator

Lam Elaine, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Institutional Review Board

Study ID:

12-1025.cc

NCT ID:

NCT01869218

Start Date:

November 2012

Completion Date:

November 2016

Related Keywords:

  • Hematologic Neoplasms
  • Cancer
  • Advanced
  • Solid
  • Hematological
  • Malignancy
  • Tissue
  • Bank
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262