Protocol Summary

Protocol No.: 13631

Sponsor Protocol No.: EAY131, MATCH

Study Title
Molecular Analysis for Therapy Choice (MATCH)

Principal Investigator(s)
George, Thomas

Objective
This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Description
(Screening): Patients undergo biopsy along with molecular characterization of the biopsy material for specific, pre-defined mutations, amplifications, or translocations of interest via tumor sequencing and immunohistochemistry. Consenting patients also undergo collection of blood samples for research purposes.

(Treatment): Patients are assigned to 1 of 24 treatment subprotocols based on molecularly-defined subgroup.

(Re-screening): Patients experiencing disease progression on the prior Step treatment or who could not tolerate the assigned treatment undergo review of their previous biopsy results to determine if another treatment is available or undergo another biopsy. Patients may have a maximum of 2 screening biopsies and 2 treatments per biopsy.

(Optional Research): Consenting patients undergo end-of-treatment biopsy and collection of blood samples for research purposes.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.

Phase: Phase II

Age Group: Adult

Scope: National

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years old and older
2. Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma requiring therapy and that has progressed following at least one line of standard systemic therapy and/or for whose disease no standard treatment exists that has been shown to prolong survival
- NOTE: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated stage I or II cancer from which the patient is currently in complete remission; any other cancer from which the patient has been disease-free for 5 years
3. Patients must have measurable disease
4. Patients must meet one of the following criteria:
- Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling; patients with multiple myeloma are to have a bone marrow aspirate to obtain tumor cells; biopsy must not be considered to be more than minimal risk to the patient
- Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected
- Formalin-fixed paraffin-embedded (FFPE) tumor tissue block(s) are available for submission following pre-registration (not applicable for bone marrow aspirate specimens); criteria for the submission of FFPE tissue are:
- Tissue must have been collected within 6 months prior to pre-registration
- Patient has not received any intervening therapy that is considered to be targeted (e.g. against a particular or multiple molecular target) for their cancer since the collection of the tumor sample; they may have received cytoxic chemotherapy for up to 4 cycles, but must not have had response to such treatment
- Formalin-fixed paraffin-embedded tumor tissue block(s) must meet the minimum requirements
5. Patient must not require the use of full dose coumarin-derivative anticoagulants such as warfarin; low molecular weight heparin is permitted for prophylactic or therapeutic use; factor X inhibitors are permitted
- NOTE: Warfarin may not be started while enrolled in the EAY131 study
- Stopping the anticoagulation for biopsy should be per site standard operating procedure (SOP)
6. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =7. Patients must not currently be receiving any other investigational agents

** Contact the study team for the full listing of Inclusion and Exclusion criteria.

Applicable Disease Sites
Bladder Cancer
Brain and Nervous System
Breast Cancer
Colon Cancer
Gastrointestinal Cancer
Gynecologic Cancer
Head & Neck Cancer
Kidney Cancer (Renal Cell)
Liver Cancer
Lung Cancer
Lymphoma - Hodgkin
Lymphoma - Non-Hodgkin
Melanoma
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Sarcoma
Skin Cancer
Urologic Cancer

Participating Institutions
UF Gainesville

Contact
Elena Nelson
Phone: 352-265-0680
Phone Extension: 50144
Email: eab1109@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02465060