*Substudy cohort palbociclib/ pancreatic/ CDKN2A mutation or loss is closed to accrual

*Substudy cohort palbociclib/ gallbladder and bile ducts/ CDKN2A loss or mutation is closed. *Substudy cohort olaparib/HER2-negative metastatic breast/ deleterious (or suspected) germline BRCA-mutated is closed to accrual

*Substudy cohorts with vismodegib and erlotinib closed.

*Substudy cohort sunitinib/ colorectal/ FLT-3 mutation or amplification is suspended.
*Substudy cohort olaparib/pancreatic/germline or somatic BRCA1/2 inactivating mutations is suspended.
*Pfizer drug substudy cohorts suspended.
*Substudy cohort cetuximab/breast/ KRAS, NRAS and BRAF wildtype (all) is suspended.

-Patients with metastatic or advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma who have exhausted standard treatment options or for whom no standard treatment is available are eligible to participate in this study.
-A potentially actionable genomic variant must be present, as revealed by a tumor genomic test or IHC test for protein overexpression that has been previously performed on a specimen of the tumor or on cell-free DNA obtained from plasma
-ECOG PS must be 0-2
-Patients must have measurable or evaluable disease by physical or radiographic exam
-Patients must 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
-Patients must NOT have ongoing toxicity greater than grade 1, other than peripheral neuropathy.
-Patients must NOT have peripheral neuropathy greater than grade 3.
-Patients must not have been previously treated with the selected study drug for the same malignancy
-If disease has a genomic variant known to confer resistance to an available anti-cancer agent available, the patient is not eligible to receive it; however, the patient may be eligible for other available drugs in this study
-Patients with known active progressive brain mets are not eligible.
-Patients must meet the drug-specific inclusion and exclusion criteria defined by their genomic testing results.

*Credentialing required for each participating staff member. Please check your staff's credentialing status.*
*Check for eligibility to DCP-001

-Must be at least 70 years old
-Must have diagnosis of advanced solid tumor malignancy or lymphoma. (Stage IV or stage III if cure is not possible or anticipated).
-Must plan to start new treatment with chemo or prevalent toxicity within 4 weeks from baseline and plan to continue this treatment for at least 3 months
-Patients are allowed to receive concurrent RT
-Patients are allowed to simultaneous participate in a treatment trial
-Must have at least one geriatric assessment domain meet the cut-off score for impairment (other than polypharmacy)
-Must have understanding of English
-Must NOT have surgery planned within 3 months
-Must not have presence of CNS disease. Patients with history of treated brain mets are eligible if they are asymptomatic

*Credentialing required for each participating staff member. Please check your staff's credentialing status.*
*Check for eligibility to DCP-001*

-Patients must be at least 70 years old
-Must have diagnosis of an advanced solid tumor malignancy (stage IV or stage III if cure is not possible or anticipated)
-Must be considering or currently receiving any kind of cancer treatment. Patients with a history of previous cancer treatment are eligible.
-Must have at least 1 geriatric assessment domain meet the cut-off score for impairment (other than polypharmacy)
-Must have visits planned with oncologist for at least 3 months
-Must have adequate understanding of English
-Must not have surgery planned within 3 months
-Must not have already decided not to undergo any cancer treatment

Credentialing required. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED: SJMH, Genesys Hurley, Hurley, Saginaw , St John, St. Joe Oakland, Sparrow, Holy Cross

-Have a diagnosis of breast cancer and be chemotherapy naïve. Note: Prior methotrexate for non-cancerous conditions is allowed.
-Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin.
-Be scheduled to receive an antiemetic regimen that does not contain Akynzeo®.
-Be able to read English (Spanish materials not provided)
-Have ECOG performance status of 0, 1, or 2
Cycle 2

- Only participants with a nausea score > 3 at least once on the diary assessment from Cycle 1 can be randomized for Cycle 2.
-Participants must be scheduled to receive the same chemotherapy regimen as received at Cycle 1.

Participants must not:
-Have a known history of central nervous system disease
-Have uncontrolled diabetes mellitus or uncontrolled hyperglycemia.

  IRB approval date 11/26/24

For REDCap Access please email:  URCC_18007@urmc.rochester.edu 

**Prior to 1st patient enrollment, contact URCC at URCC_18007@URMC.Rochester.edu and verify that your site has completed all protocol training (REDCap User, PHARMA SHIPPING DESIGNEE FORM, lab Blood processing )

Eligibility Criteria:

Participants must:

- Be at least 18 years of age

- Be female

- Have a diagnosis of Stage I-III breast cancer

- Report WORST level of fatigue in the past week as moderate to severe (i.e., a score = 4 on a 0-10 scale, Screening Measures, question 1)18, 78

- Have completed surgery, radiation, and/or chemotherapy 2 or more months prior to enrollment (participants can be receiving maintenance, targeted, or hormonal therapy)

- Able to read and speak English

- Currently not pregnant or breastfeeding. Women of child-bearing potential must agree to use adequate contraception, i.e., abstinence, IUD (intrauterine device), hormonal contraceptive (birth control pills) or barrier method (condoms) prior to study entry and for the duration of study participation

- Be capable of providing written informed consent

Participants must not:

- Be currently taking any medications that contain bupropion (e.g., Wellbutrin, Forfivo, Aplenzin, or Zyban)

- Be taking an MAOI, linezolid, or methylene blue within two weeks prior to enrollment

- Be taking any anti-psychotic medications within a week prior to enrollment

- Have a history of renal impairment (i.e., glomerular filtration rate 45)

- Have a history of cirrhosis (i.e., Child-Pugh score = 5)

- Have a history of seizures

- Have a history of bulimia or anorexia nervosa

- Report a history of sensitivity to bupropion

- Report an allergy to lactose

- Have psychiatric or neurological disorder that would interfere with study participation per physician or physician’s designee.

CREDENTIALING REQUIRED. Please check your site's credentialing status.

CURRENT SITES CREDENTIALED: SJMH (Ann Arbor)

Eligibility Criteria:

Inclusion Criteria for Patients

- English-speaking as not all patient measures have been validated in other languages

- Age = 18

- Willing to complete palliative care assessment and ENABLE sessions

- Diagnosed within the last 90 days with an advanced cancer (defined as a newly diagnosed stage III/IV, recurrence, or progressive solid tumor cancer).

- Expected survival of at least 6 months

- Have access to telephone that can receive calls

- Able to provide informed consent

Exclusion Criteria for Patients

- Received previous palliative care services

CREDENTIALING REQUIRED. Please check your site's credentialing status.

CURRENT SITES CREDENTIALED: SJMH TH (Ann Abor, Brighton, Canton, Chelsea, Livonia), Oakland, Genesys, Hurley, Lehigh

Eligibility Criteria:

4.1.1. Be 18 years of age or older

4.1.2. Self-identify as African/African American/Black (AA), or European American/ Caucasian/white (EA)

- Patients may identify a Hispanic/Latino ethnicity in combination with an AA or EA racial identity

4.1.3. Have a current diagnosis of invasive cancer at stage I-IV

- Patients may have a history of previous cancer diagnosis and cancer treatment not involving immunotherapy

4.1.4. Be scheduled to receive anti-PD-1/-L1 ICI-containing therapy according to FDA labels or NCCN guidelines at Category 1 or 2A as standard of care treatment alone or in combination with co-treatments (including alternative ICIs)

4.1.5. Be able to speak and read English or Spanish

4.1.6. Be able to provide written or remote informed consent

**PLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELIGIBILITY LIST**

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED: SJMH (Ann Arbor, Brighton, Chelsea, Canton), St. Mary's Livonia, LVHN

Eligibility Criteria:

Inclusion Criteria 

-Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV) obtained at the time of a partial or gross total resection of the tumor. Patients who undergo a stereotactic needle biopsy alone are not eligible.   

- The tumor must have a supratentorial component.

- History/physical examination within 14 days prior to enrollment

- The patient must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment.    

-Patient planning to receive brain RT, and concurrent and adjuvant temozolomide chemotherapy for 6 weeks as per standard of care therapy. Use of the Optune® (also known as Tumor Treating Fields or TTFields) device is allowed at provider discretion, but must begin after the Month 1 Post RT (10 wk) Neurocognitive-PRO assessment. 

-Study drug (Ramipril) must be given > 21 days and ≤ 35 days after surgery.

-All available brain MRI or CT imaging reports from surgery to study completion must be submitted. This includes any post-operative or pre-radiation scan reports.  

-ECOG 0, 1 or 2;

-Age ≥ 18;

-CBC/differential obtained within 14 days prior to enrollment, with adequate bone marrow function defined as follows:

? Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;

? Platelets ≥ 100,000 cells/mm3;

? Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥10.0 g/dl is acceptable.)

Adequate renal function, as defined below:

? BUN ≤ 30 mg/dl within 14 days prior to enrollment.

? Creatinine ≤ 1.7 mg/dl within 14 days prior to enrollment.

Adequate hepatic function, as defined below:

? Total Bilirubin ≤ 2.0 mg/dl within 14 days prior to enrollment.

? ALT/AST ≤ 3 x normal range within 14 days prior to enrollment.

Patient must provide study specific informed consent prior to study entry. 

- Baseline potassium level 5.0. High potassium values that are thought to be a result of sample hemolysis may be repeated to determine an accurate potassium level and to determine potential study eligibility. Likewise high potassium values thought to be a result of potassium supplementation may be repeated at an appropriate time (5 half-lives after supplement discontinuation) to determine potential study eligibility.    

-Patient must be able to complete neurocognitive tests in the English language as they are 

not validated in other languages at this time. 

- Women of childbearing potential and male participants must practice adequate contraception. 

- For females of child-bearing potential, negative serum or urine pregnancy test within 14 

days of enrollment 

- Local site must be able to follow the standard GBM radiation treatment dosimetry plan 

as detailed in Section 5.1.1.2 

- For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following inclusion criteria also apply: 

 ? Patients must have only a supratentorial glioblastoma

? The treating physician must be a qualified provider having successfully completed the training course provided by Novocure, the device manufacturer

 Patients with prior malignancies if all treatment for that malignancy was completed at 

least 2 years before registration and the patient has no evidence of disease.

Exclusion Criteria 

-Prior allergic reaction or intolerance to ACE inhibitor 

-Hypotension (110 mg Hg systolic) at the time of enrollment

- Renal insufficiency with creatinine clearance of 40 ml/min (at time of enrollment)

-Solitary kidney or known renal artery stenosis

-Current ACE inhibitor or angiotensin receptor blocker use. Patients can come off ACE inhibitors or angiotensin receptor blockers for 1 week to be eligible for this study. 

-Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 2 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).  

-Recurrent or multifocal malignant gliomas

-Metastases detected below the tentorium or beyond the cranial vault.

-Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.  

-Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap 

of radiation fields.  

- Severe, active co-morbidity, defined as follows: 

? Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment

? Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment.

? Known HIV positivity or acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

? Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.

? Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.

-Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.  

-Pregnant or lactating women, due to possible adverse effects on the developing fetus or 

infant due to study drug. 

- Patients treated on any other therapeutic clinical protocols within 30 days prior to study 

entry or during participation in the study.  

- Patients planning to receive therapeutic antitumor agents (excluding use of the Tumor Treating Fields (TTFields or Optune®) device after the Month 1 Post RT (10 wk) Neurocognitive-PRO assessment.) in addition to standard radiation and concurrent and adjuvant temozolomide are not eligible to participate in this study. 

-Patients with impaired decision-making capacity; this exclusion is necessary because such 

patients may not be able to adequately give informed consent. 

- For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following exclusion criteria also apply: 

  -Optune® is not permitted in patients who have an active implanted medical device, skull defect (such as, missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmatic shunts. 

   - Optune® is not permitted in patients who are known to be sensitive to conductive hydrogels. Examples of conductive hydrogels are gels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. 

Inclusion of Women and Minorities 

-Both men and women and members of all races and ethnic groups are eligible for this trial. 

** Effective 06/10/2024 Age 60-74 Stratum is Closed to Patient Accrual**

CREDENTIALING REQUIRED. Please check your site's credentialing status.

Please see "study start up email" in the documents library for credentialing requirements
CURRENT SITES CREDENTIALED: SJMH, Genesys, SMML, SJMO

 BL requirements can be collected up to 4 weeks after treatment starts. 

Eligibility Criteria:

Inclusion Criteria:

- Older adults (age = 65y) with either

    newly diagnosed metastatic CRC or

    newly recognized metastatic recurrence of CRC greater than 1 year from completion of  treatment for non-metastatic CRC  

- Planning to undergo 1st line 5-FU based chemotherapy (as monotherapy [as 5-FU alone or capecitabine] or in combination with oxaliplatin and/or irinotecan +/- biologics).

- Estimated life expectancy =6 months.

- Patients must be able to read and comprehend English or Spanish (for questionnaire completion).

- Ability to understand and the willingness to sign a written informed consent document.

- Patient eligibility is not dependent on BMI or weight. Patients with a significant (± > 10%) body weight change in the previous 12 months are eligible for this study.

Exclusion Criteria:

- Patients enrolled on hospice.

- Prior systemic chemotherapy for metastatic colorectal cancer (acceptable if adjuvant chemotherapy completed =12 months prior to disease recurrence).

- Patients may not be receiving any other investigational agents.

- No untreated brain metastases. Patients with treated brain metastases are eligible.

Inclusion of Women and Minorities:

- Both men and women (as applicable) and members of all races and ethnic groups are eligible for this trial.