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TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

RecruitingPhase 2

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Who can join

Ages 12 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 12 years of age or older (\*Restrictions apply. Not all therapies are available for patients \<18)
* Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefiting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated (except under the circumstance in which the TAPUR arm is designed to provide additional evidence to support an existing FDA indication).
* Performance status 0-2 (Per Eastern Cooperative Oncology Group (ECOG) criteria)
* Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:

  1. Absolute neutrophil count ≥ 1500 µl
  2. Hemoglobin ≥ 9.0 g/dl
  3. Platelets ≥ 75,000/µl
  4. Total bilirubin \< 2.0 mg/ dl, except in patients with Gilbert's Syndrome
  5. Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) \< 2.5 x institutional upper limit of normal (ULN) (or \< 5 x ULN in patients with known hepatic metastases)
  6. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
* Patients must have disease that can be objectively measured by physical, laboratory or radiographic exam (per RECIST v1.1 for solid tumor, Lugano criteria for non-Hodgkin lymphoma or International Myeloma Working Group criteria for multiple myeloma).
* Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited or New York State accredited (for labs offering services to residents of NY) laboratory. Labs that have registered the test with the NIH Genetic Testing Registry or that provide a report that has been designated as optimized for TAPUR participation are preferred, but not required. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma ("liquid biopsies") will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above.
* Ability to understand and the willingness to sign a written informed consent/assent document.
* Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in protocol.
* For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
* Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and for a specified amount of time the last dose of study treatment, or completely abstain from sexual intercourse.

Note: TAPUR does not explicitly exclude any type of solid tumor, but the patient must have measurable and evaluable disease per RECIST v1.1.

Exclusion Criteria:

* Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible
* Patients with primary brain tumors or new, untreated or progressive leptomeningeal metastases are excluded
* Patients with previously treated brain metastases or previously treated leptomeningeal disease are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 1 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment.
* Patients with known progressive brain metastases are eligible but additional eligibility criteria apply.

Note: there are additional exclusion criteria that may apply

About the study

The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.

NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers).

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Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress.

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What is being tested

Sponsor: American Society of Clinical Oncology · Participants: 4,200 · Started: Mar 14, 2016

Contact the study team

Official record on ClinicalTrials.gov — NCT02693535

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham Comprehensive Cancer Center, Birmingham
ArizonaCancer Treatment Centers of America-Phoenix, Phoenix
CaliforniaSutter Auburn, Auburn
Sutter Alta Bates, Berkeley
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Los Angeles
Kaiser Permanente - Oakland Medical Center, Oakland
Sutter Palo Alto Medical Foundation: Palo Alto, Palo Alto
Kaiser Permanente - Roseville Medical Center, Roseville
Sutter Roseville, Roseville
Kaiser Permanente - Sacramento Medical Center, Sacramento
Sutter Sacramento, Sacramento
California Pacific Medical Center Research Institute, San Francisco
Kaiser Permanente - San Francisco Medical Center, San Francisco
Kaiser Permanente - South San Francisco Medical Center, San Francisco
Sutter Cancer Research Consortium, San Francisco
Kaiser Permanente - San Jose Medical Center, San Jose
Kaiser Permanente - San Leandro Medical Center, San Leandro
Sutter Sansum Clinic, Santa Barbara
Kaiser Permanente - Santa Clara Medical Center, Santa Clara
Sutter Palo Alto Medical Foundation: Fremont, Santa Cruz
Sutter Palo Alto Medical Foundation: Santa Cruz, Santa Cruz
Sutter Palo Alto Medical Foundation: Sunnyvale, Sunnyvale
Kaiser Permanente - Vallejo Medical Center, Vallejo
Kaiser Permanente - Walnut Creek Medical Center, Walnut Creek
ConnecticutSaint Vincent's Medical Center (SVMC), Bridgeport
Hartford Hospital, Hartford
Midstate Medical Center (MSMC), Meriden
The Hospital of Central Connecticut (HOCC) Cancer Center, New Britain
William W. Backus Hospital, Norwich
Charlotte Hungerford, Torrington
Windham Hospital (WH), Willimantic
FloridaUniversity of Miami/Sylvester Cancer Institute - Aventura, Aventura
University of Miami/Sylvester Cancer Institute - Lennar, Coral Gables
University of Miami/Sylvester Cancer Institute - Deerfield Beach, Deerfield Beach
Holy Cross Hospital, Fort Lauderdale
University of Florida Health, Gainesville
University of Miami Sylvester Comprehensive Cancer Center, Miami
University of Miami/Sylvester Cancer Institute - Alex's Place, Miami
University of Miami/Sylvester Cancer Institute - Griffin Cancer Research Building, Miami
University of Miami/Sylvester Cancer Institute - Kendall, Miami
University of Miami/Sylvester Cancer Institute - Sole Mia, Miami
University of Miami/Sylvester Cancer Institute - Plantation, Plantation
GeorgiaCancer Treatment Centers of America - Atlanta, Atlanta
Emory University Winship Cancer Institute, Atlanta
Gynecologic Oncology and Surgical Specialists at the Lewis Cancer & Research Pavilion, Savannah
Lewis Cancer & Research Pavilion, Savannah
Lewis Cancer & Research Pavilion at the Melanoma, Skin Cancer & Sarcoma Institute, Savannah
Summit Cancer Care, Savannah
HawaiiThe Queen's Medical Center - Kuakini, Honolulu
The Queen's Medical Center - POB I, Honolulu
The Queen's Medical Center - Punchbowl, Honolulu
The Queen's Medical Center - West Oahu, ‘Ewa Beach
IllinoisCancer Treatment Centers of America-Chicago, Chicago
IndianaCommunity Health Network (The University of Texas MD Anderson Cancer Center), Indianapolis
MaineHarold Alfond Center for Cancer Care, Augusta
Jackson Laboratory - Maine Cancer Genomics Initiative, Augusta
Waldo County General Hospital, Belfast
SMHC Cancer Care and Blood Disorders -Biddeford, Biddeford
Northern Light Cancer Care, Brewer
Raish Peavey Haskell Children's Cancer and Treatment Center, Brewer
MaineHealth Cancer Care -Brunswick, Brunswick
New England Cancer Specialist, Kennebunk
York Hopsital Oncology & Infusion Care in Kittery, Kittery
Stephens Memorial Hospital, Norway
Penobscot Bay Medical Center, Rockport
SMHC Cancer Care and Blood Disorders -Sandford, Sanford
Maine Children's Cancer Program, Scarborough
Maine Medical Partner's Women's Health, Scarborough
New England Cancer Specialist, Scarborough
MaineHealth Cancer Care -South Portland, South Portland
New England Cancer Specialist, Topsham
York Hospital Oncology & Infusion Care in Wells, Wells
York Hospital Oncology & Infusion Care in York, York Village
MichiganTrinity Health Ann Arbor Hospital, Ann Arbor
Henry Ford Health Saint John Hospital, Detroit
Genesys Hurley Cancer Institute, Flint
Cancer Research Consortium of West Michigan, Grand Rapids
University of Michigan Health - Sparrow Lansing, Lansing
Trinity Health Livonia Hospital, Livonia
Trinity Health Oakland Hospital, Pontiac
MyMichigan Medical Center Saginaw, Saginaw
Michigan Cancer Research Consortium, Traverse City
Henry Ford Health Warren Hospital, Warren
NebraskaUniversity of Nebraska Medical Center, Omaha
New HampshireNH Oncology - Hematology, PA, Concord
Solinsky Center for Cancer Care, Manchester
New England Cancer Specialist, Portsmouth
New MexicoLovelace Medical Center - Saint Joseph Square, Albuquerque
Presbyterian Kaseman Hospital, Albuquerque
The University of New Mexico Comprehensive Cancer Center, Albuquerque
Memorial Medical Center, Las Cruces
Presbyterian Rust Medical Center, Rio Rancho
New YorkNorthwell Health Monter Cancer Center, Lake Success
Northern Westchester Hospital, Mount Kisco
Cohen Children's Medical Center, New Hyde Park
Manhattan Eye, Ear, and Throat Hospital, New York
Staten Island University Hospital, New York
Queens Cancer Center, Rego Park
Phelps Hospital, Sleepy Hollow
North CarolinaLineberger Comprehensive Cancer Center, Chapel Hill
Atrium Health's Levine Cancer Institute, Charlotte
North DakotaSanford Health- Bismarck, Bismarck
Sanford Health- Fargo, Fargo
OhioUniversity of Cincinnati Medical Center, Cincinnati
Kettering Health, Kettering
West Chester Hospital, West Chester
OregonProvidence Health & Services, Portland
PennsylvaniaLehigh Valley Hospital - Cedar Crest, Allentown
Lehigh Valley Hospital- Muhlenberg, Bethlehem
Pocono Medical Center, East Stroudsburg
Lehigh Valley Hospital-Hazleton, Hazleton
Fox Chase Cancer Center, Philadelphia
South CarolinaSC Cancer Specialists at St. Joseph's/Candler Bluffton, Bluffton
St. Joseph's/Candler Smith, Bluffton
Summit Cancer Care at St. Josph's/Candler Bluffton, Bluffton
South Carolina Cancer Specialists, Hilton Head Island
South DakotaSanford Cancer Center Oncology Clinic and Pharmacy, Sioux Falls
TennesseeTennessee Oncology - Nashville / Sarah Cannon Research Institute, Nashville
TexasThe University of Texas MD Anderson Cancer Center, Houston
UtahCedar City Hospital, SW Cancer Clinic, Sandra Maxwell Cancer Center, Cedar City
Intermountain Healthcare, Salt Lake City
Dixie Regional Medical Center-River Road Campus, St. George
VirginiaInova Schar Cancer Institute, Fairfax
WashingtonNorthwest Medical Specialties, Bonney Lake
Northwest Medical Specialties, Federal Way
Northwest Medical Specialties, Gig Harbor
Northwest Medical Specialties, Olympia
Northwest Medical Specialties, Puyallup
Swedish Cancer Institute, Seattle
Northwest Medical Specialties, Tacoma
WisconsinAurora Cancer Care - Burlington, Burlington
Aurora Health Care - Germantown Health Center, Germantown
Aurora Cancer Care - Grafton, Grafton
Aurora BayCare Medical Center, Green Bay
Aurora Cancer Care - Kenosha South, Kenosha
Aurora Bay Area Medical Center, Marinette
Aurora Cancer Care Milwaukee, Milwaukee
Aurora Sinai Medical Center, Milwaukee
Aurora St. Luke's Medical Center, Milwaukee
Aurora West Allis Medical Center, Milwaukee
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh
Aurora Cancer Care - Racine, Racine
Vince Lombardi Cancer Center, Sheboygan
Aurora Medical Center in Summit, Summit
Vince Lombardi Cancer Clinic - Two Rivers, Two Rivers
Aurora Cancer Care - Milwaukee West, Wauwatosa

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.