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โ† Trials
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At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

RecruitingPhase 2Ages 18 Years - anyAllMayo Clinic
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In plain words

What the trial is, and whether it could suit you

This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovativ

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required. * Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines. * Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens: * Eligible disease cancer types: * Anal cancer * Appendiceal carcinoma * Basal cell carcinoma * Bladder cancer * Biliary cancer * Breast cancer * Central Nervous System malignancy including glioblastoma * Cervical cancer * Cholangiocarcinoma * Colorectal carcinoma * Endometrial cancer * Fallopian tube cancer * Gastroesophageal cancer \[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\] * Germ cell carcinoma * Head and Neck cancer * Hepatocellular Carcinoma * Liver * Lung * Lymphoma * Melanoma * Merkel Cell * Multiple Myeloma * Myelodysplastic syndrome * Myeloid Disorders * Neuroendocrine carcinoma * Ovarian cancer * Pancreatic adenocarcinoma * Penile carcinoma * Peritoneal carcinoma * Prostate cancer * Renal cell cancer * Sarcoma * Squamous cell Carcinoma of the Skin * Testicular cancer * Urethral carcinoma * Vaginal carcinoma * Vulvar carcinoma * Eligible Regimens * Fluorouracil (5-FU) +/- leucovorin +/- bevacizumab +/- trastuzumab * 5FU +/- leucovorin +/- bevacizumab +/- nivolumab * Atezolizumab +/- bevacizumab * Atezolizumab +/- bevacizumab + cobimetinib, atezolizumab +/- bevacizumab + vemurafenib, atezolizumab +/- bevacizumab + cobimetinib + vemurafenib * Avelumab * Avelumab + axitinib * Bevacizumab * Bevacizumab + capecitabine * Bevacizumab + irinotecan (+/- capecitabine) * Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib * Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus * Bevacizumab + trifluridine/tipiracil * Bortezomib * Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor * Bortezomib + venetoclax * Carfilzomib * Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor * Carfilzomib + venetoclax * Cemiplimab * Cisplatin * Cisplatin/5-FU * Cisplatin/etoposide * Cisplatin + durvalumab * Cisplatin + gemcitabine * Cisplatin + gemcitabine + durvalumab * Daratumumab (+ oral \[PO\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor) * Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor) * Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor) * Degarelix * Durvalumab * Durvalumab + tremelimumab * Eribulin * FOLFIRI +/- bevacizumab (5FU +/- leucovorin + irinotecan) * Fam-trastuzumab deruxtecan * Fulvestrant * Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib * Gemcitabine * Gemcitabine + durvalumab * Gemcitabine + paclitaxel protein-bound * Goserelin acetate * Irinotecan * Irinotecan + capecitabine * Lanreotide * Leuprolide * Nivolumab * Nivolumab + cabozantinib * Nivolumab-relatlimab * Octreotide * Paclitaxel * Pembrolizumab * Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +/- trametinib, pembrolizumab + trametinib) * Pemetrexed * Pertuzumab * Pemetrexed + pembrolizumab * Rituximab * Trastuzumab + paclitaxel * Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+/- tucatinib +/- capecitabine) * Decitabine * These regimens can be used only if patients are receiving one of the regimens above: * Darbepoetin-alfa * Epoetin * Filgrastim * Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as: * Zoledronic acid * Denosumab * Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent * Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization. * Residing within the area serviced by supplier and paramedic network * Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution * Age \>= 18 years at time of registration * Signed informed consent form by patient * Willing and able to comply with the study protocol in the investigator's judgement * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 *
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What it tests

  • Clinical Encounter
  • Home Health Encounter
  • Quality-of-Life Assessment
  • Questionnaire Administration
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Where

2 sites
Mayo Clinic in Florida
Jacksonville, United States
Altru Cancer Center
Grand Forks, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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