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.

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED: 

Eligibility Criteria: SJMH (AA, Brighton, Canton, Chelsea), Livonia, GenHur

**TT SJMH: MI013, MI221, MI294, and MI327 only  

- Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy.

- May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive as per treating clinician judgement at the time of screening.

- Patients who are no longer receiving anticancer therapy must be ≤ 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last day of radiotherapy, etc.).

- Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview within the Screening Interview.

- Must have a score of “Most Days” or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview within the Screening Interview.  

Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen over a period of at least 14 days prior to enrollment.

- Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment.  

***See the Protocol for the full eligibility criteria list*** 

**MI013 IS THE ONLY SJMH SITE ELIGIBLE TO OPEN**

*DTL Required- Physicians must sign toxicity grid

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED: TH SJMH Ann Arbor , Genesys

Eligibility Criteria:

4.1.1 At least one intact brain metastasis or resection cavity ≥ 2 cm in diameter or ≥ 4 cc volume with no prior history of radiation therapy for brain metastasis.

• Both patients at initial diagnosis of brain metastases and patients known brain metastasis treated with systemic therapy alone are eligible

• Lesion volume will be approximated by measuring the lesion’s three perpendicular diameters WF-2201 Version Date: 01/15/2023 Page 16 of 73 Wake Forest NCORP Research Base HYPOGRYPHE on contrast-enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g., xyz/2). Alternatively, direct volumetric measurements via slice-by-slice contouring on a treatment planning software package can be used to calculate the total tumor volume.

• Any extent of non-CNS disease is allowed. There is no requirement for non-CNS disease to be controlled prior to study entry. 

4.1.2 Age ≥ 18 years at the time of enrollment.

4.1.3 Total number of brain metastases (including resection cavities) < 15 on diagnostic MRI; all lesions must be amenable to SSRS and FSRS as determined by the treating radiation oncologist. Treatment must take place at a facility credentialed by the Imaging and Radiation Oncology Core (IROC) for SRS and that offers both SSRS and FSRS as treatment options.

4.1.4 Total gross tumor volume must be < 30 cc. Lesion volume will be approximated by measuring each lesion’s three perpendicular diameters on contrast-enhanced T1 MRI and the product of those diameters will be divided by 2 (V = xyz/2). Direct volumetric measurements by contouring all lesions on all visible slices on treatment planning software is also acceptable. If there is a cavity, only gross residual disease within or adjacent to the cavity is counted toward the 30 cc total volume.

4.1.5 Ability to tolerate MRI brain with gadolinium-based contrast.

4.1.6 Pathologically confirmed melanoma, renal cell carcinoma, non-small cell lung cancer, or breast cancer.

4.1.7 Has received, is currently receiving, or is planned to receive immune checkpoint inhibitor therapy (defined as agent targeted to PD-1/PD-L1 axis) within 30 days of the planned first day of SSRS/FSRS. Dual ICI therapy with PD-1/PD-L1 and CTLA-4 targeted agents are allowed, but patients treated with a single agent CTLA-4 targeted agent only are ineligible.

4.1.8 Karnofsky Performance Status (KPS) ≥ 70. Refer to Appendix A. 4.1.9 Negative serum or urine pregnancy test within 14 days of randomization for women of childbearing potential 

 ***PLLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELGIBILITY LIST***

Eligibility Criteria

 4.1 Inclusion Criteria

4.1.1 History of Stage 0-III breast cancer diagnosis. History of non-breast malignancies are permitted. 4.1.2 ≥12 weeks following last primary cancer treatment. For this protocol, primary cancer treatments are defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and surgical procedures intended to remove malignant tissue. Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), HER2-based Monoclonal antibody therapy (e.g., trastuzumab, pertuzumab), HER2 targeted Tyrosine Kinase inhibitors(e.g., neratinib), and/or pending breast reconstructive surgery are allowed. (There is no upper limit on time since treatment. This is due to criterion 4.1.7 below – participants must endorse current sexual morbidity that they believe is related to their breast cancer. Breast cancer-related sexual morbidity often persists, or even worsens, years following treatment

4.1.3 Age ≥18 years at the time of study enrollment. Items below will be asked on the Self-reported Eligibility Screener to the patient directly:

4.1.4 Cisgender female (i.e., assigned female at birth, female gender identity);

4.1.5 Currently in an intimate relationship, as reported on the PROMIS SexFS screener1 (this relationship may be with an individual of any sex and gender identity);

4.1.6 Endorse being at least “somewhat” bothered by ≥1 of the following during the last 30 days: (lack of) interest in sexual activity, vaginal dryness, pain during sexual activity, or (in)ability to orgasm, as reported on the PROMIS SexFS Bother Regarding Sexual Function1 screener;

4.1.7 Endorse that ≥1 of the bothersome sexual symptoms, from the PROMIS SexFS Bother Regarding Sexual Function1 screener (see 4.1.6) is related to their breast cancer;

4.1.8 Has a working email address (or willing to create one) and receive emails from the study.

4.2 Exclusion Criteria

4.2.1 Planned cancer treatment for residual, progressive, or recurrent disease within the 24 weeks following enrollment (defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and/or surgical procedures intended to remove malignant tissue). Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), HER2- based Monoclonal antibody therapy (e.g., trastuzumab, pertuzumab), HER2 targeted Tyrosine Kinase inhibitors (e.g., neratinib), and/or pending breast reconstructive surgery are allowed.

4.2.2 Unable to read and comprehend English (SHINE intervention currently only available in English) as indicated by being unable to complete the Self-reported Screening Questionnaire independently. Items below will be asked on the Self-reported Eligibility Screener to the patient directly:

4.2.3 Does not have reliable access to Internet (e.g., by home broadband, public network, personal data plan) by computer, tablet, smartphone etc. and is not willing to participate in the tablet lending program for this study.

4.2.4 Recent serious mental illness, as defined by reporting an inpatient psychiatric hospitalization within the past 12 months.

4.2.5 Currently participating in couple, marital, or sex therapy.  

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

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

CURRENT SITES CREDENTIALED: Trinity Health Ann Arbor Hospital, Genesys, SJMO

Eligibility Criteria:

4.1 Inclusion Criteria

4.1.1 Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer.

4.1.2 Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment.

4.1.3 Participants must be able to comprehend English or Spanish (for survey completion).

4.1.4 Participant must have a working email address and be willing to complete surveys online. This can be completed at home, in the clinic or other location.

4.1.5 Completion of the confidential Self-reported Screening Survey and receipt of a screening result - eligible for enrollment.  

4.2 Exclusion Criteria

4.2.1 Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms. 4.2.2 Participants with known pregnancy 

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

***If a patient is eligible for continued access to study treatment after the end of study, they can be rolled over to the Access Solutions & Patient Support team (WEBSITE).