araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia

Summary: RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem cell donor and the patient may reduce the chance of developing graft-versus-host disease following stem cell transplantation.
  PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer or aplastic anemia.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of sargramostim (GM-CSF) to mobilize CD34+ hematopoietic stem cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem cell transplantation (SCT) for hematologic malignancy or aplastic anemia.
  -  Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients.
  OUTLINE: This is a pilot study.
  -  Donors: Donors receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-6. Donors undergo stem cell harvest on day 7.
  Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may receive additional GM-CSF prior to each collection.
  -  Patients: Patients receive conditioning therapy as per transplantation protocol RP98-15. Patients undergo allogeneic stem cell transplantation on day 0. Patients then receive GM-CSF SC once daily beginning on day 7 and continuing until blood counts recover.
  Patients are followed weekly until day 100 and then at days 180 and 360.
  PROJECTED ACCRUAL: A total of 10 patients and 10 donors will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of a malignant hematologic disease, including:
  -  Acute or chronic leukemia
  -  Myelodysplastic syndromes
  -  Myeloproliferative disorder
  -  Hodgkin's lymphoma
  -  Non-Hodgkin's lymphoma OR
  -  Aplastic anemia
  -  Planned transplantation on an RPCI IRB-approved allogeneic stem cell transplantation protocol
  -  HLA-matched (6/6) related donor available
  PATIENT CHARACTERISTICS:
  Age
  -  5 to 60
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients and donors must use effective contraception
  -  No known allergy to GM-CSF
  -  No prior of adverse reaction to any yeast recombinant molecule
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  See Disease Characteristics
  -  No prior allogeneic stem cell transplantation
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

Summary: To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.


Eligibility: Inclusion Criteria:
  -  Postmenopausal women with histologically confirmed, measurable locally advanced disease or metastatic breast.
  -  Must be appropriate to receive endocrine therapy as treatment for advanced disease (chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or trastuzumab, are permitted).
  -  Women may either present with de novo advanced or metastatic cancer, or have had tumor progression while receiving adjuvant tamoxifen or at any time after completing adjuvant tamoxifen, or have had tumor progression while receiving first-line metastatic therapy with tamoxifen.
  Exclusion Criteria:
  -  Patients having known central nervous system (CNS) metastases.
  -  Prior therapy with Temsirolimus (CCI-779) or aromatase inhibitors.
  -  Tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1 week prior to day 1 of treatment on study.

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Summary: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer

Detailed description: PRIMARY OBJECTIVES:
  I. Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779.
  SECONDARY OBJECTIVES:
  I. Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.
  II. Correlate biomarkers of response with clinical response in patients treated with this drug.
  III. Determine the safety and toxicity of this drug in these patients.
  OUTLINE: This is an open-label study.
  Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 3 months.
  PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed adenocarcinoma of the pancreas
  -  Locally advanced or metastatic disease
  -  Radiographic evidence of disease
  -  No known brain metastases
  -  Performance status - ECOG 0-2
  -  More than 3 months
  -  WBC ≥ 3,000/mm^3
  -  Absolute neutrophil count ≥ 1,500/mm^3
  -  Platelet count ≥ 100,000/mm^3
  -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  -  AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
  -  Creatinine ≤ 1.5 mg/dL
  -  Creatinine clearance ≥ 50 mL/min
  -  No symptomatic congestive heart failure
  -  No unstable angina pectoris
  -  No cardiac arrhythmia
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  Fasting serum cholesterol ≤ 350 mg/dL
  -  Fasting triglycerides ≤ 400 mg/dL
  -  No ongoing or active infection
  -  No psychiatric illness or social situation that would preclude study compliance
  -  No other concurrent uncontrolled illness
  -  No concurrent prophylactic hematopoietic colony-stimulating factors
  -  No prior chemotherapy for metastatic pancreatic cancer
  -  More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer
  -  Must have radiographic evidence of recurrent disease
  -  More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer
  -  Must have radiographic evidence of disease progression
  -  See Chemotherapy
  -  See Chemotherapy
  -  No other concurrent investigational or commercial agents or therapies for the malignancy
  -  No other concurrent anticancer therapy
  -  No concurrent combination antiretroviral therapy for HIV-positive patients

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: Sirolimus as Secondary Therapy in Chronic Graft-Versus-Host Disease Not Responding To Prior Treatment

Summary: This phase II trial studies the side effects and how well sirolimus works as secondary therapy in treating patients with chronic graft-versus-host disease (GVHD) that did not respond to prior treatment. Sirolimus may be an effective treatment for chronic GVHD

Detailed description: PRIMARY OBJECTIVES:
  I. To assess the safety of sirolimus administered at a dose which provides steady-state, whole blood trough levels of 5-10 ng/mL in patients with chronic GVHD.
  II. To determine whether administration of sirolimus provides benefit for patients with chronic GVHD that has not responded adequately to previous systemic treatment.
  OUTLINE:
  Patients receive sirolimus orally (PO) once daily (QD). Patients continue to receive prednisone and cyclosporine or tacrolimus at the discretion of the managing physician.
  After completion of study treatment, patients are followed up periodically.

Eligibility: Inclusion Criteria:
  -  Biopsy-confirmed diagnosis of clinical extensive chronic GVHD with inadequate response to previous treatment and where secondary systemic therapy is indicated because of
  -  Clinical progression of signs and symptoms of chronic GVHD in a previously involved organ, or
  -  Development of signs and symptoms of chronic GVHD in a previously uninvolved organ, or
  -  Absence of improvement after 3 months of primary treatment, or
  -  Continued need for treatment with prednisone at doses >= 1.0 mg/kg/day for more than 2 months, without qualification for type of donor, graft or conditioning regimen
  -  Patient or guardian able and willing to provide informed consent
  -  Stated willingness to use contraception in women of child-bearing potential (Food and Drug Administration [FDA] requirement)
  -  Stated willingness of the patient to comply with study procedures and reporting requirements
  -  Stated willingness of the physician most involved in management of chronic GVHD (the "managing physician,") to comply with study procedures and reporting requirements
  Exclusion Criteria:
  -  Fungal or viral infection with no radiographic evidence of improvement during continued appropriate antimicrobial therapy
  -  Cytomegalovirus (CMV) antigenemia unresponsive to antiviral therapy
  -  Active disseminated varicella zoster virus (VZV) infection with persistent non-crusted lesions
  -  Inability to tolerate oral medications
  -  Absolute neutrophil count (ANC) < 1500/uL
  -  Platelet count < 50,000/uL
  -  Persistent or recurrent malignancy, including histopathologic evidence of myeloma or lymphoma; patients with breakpoint cluster region-abelson (bcr/abl) detected by polymerase chain reaction (PCR) assay as the only evidence of persistent chronic myeloid leukemia may be enrolled
  -  Pregnancy
  -  Known history of hypersensitivity to sirolimus

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

Summary: In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival.
  Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.


Eligibility: Inclusion Criteria:
  -  Women aged greater than 18 years.
  -  Postmenopausal subjects
  -  Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint Committee on Cancer Criteria)
  Exclusion Criteria:
  -  Extensive visceral disease
  -  Subjects with bone as the only site of disease
  -  Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: DNA Variations in the Gene in Young Patients With Wilms' Tumor

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at DNA variations in the RASSF1A gene in young patients with Wilms' tumor.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the presence of the A133S polymorphism in the RASSF1A tumor suppressor gene by screening germline DNAs of children with Wilms' tumor.
  -  Determine the inheritance pattern of the A133S polymorphism by evaluating the parents of children who carry this polymorphism.
  Secondary
  -  Determine the differences in age at diagnosis, stage, histology, site of primary tumor, and outcome, between patients with vs without the A133S polymorphism.
  -  Determine whether the S131F RASSF1A variant is a true polymorphism in these patients.
  -  Determine the polymorphic differences in this gene between these patients based on ethnicity and sex.
  OUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis, stage, histology, site of primary tumor, and outcome.
  Genomic DNA samples are purified from peripheral blood of patients and controls and analyzed by polymerase chain reaction for the RASSF1A gene. DNA is also analyzed from parents of patients with the A133S polymorphism.
  PROJECTED ACCRUAL: A total of 471 participants (229 Wilms' tumor patients and 200 control participants plus 42 parents) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of Wilms' tumor OR
  -  Control participants matched for race, sex, and age
  -  No prior or concurrent history of cancer OR
  -  Parents of children involved in the study
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Summary: The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.

Detailed description: The postpericardiotomy syndrome is a frequent complication after cardiac surgery affecting from 20 to 40% of patients. The etiology of this complication is a subject of debate. It is commonly believed to be an autoimmune response to pericardial and/or pleural bleeding or surgical trauma. Colchicine is safe and effective in the treatment and prevention of pericarditis and preliminary data have shown that it may be effective also in the primary prevention of the postpericardiotomy syndrome.
  Comparisons: The study will compare the safety and efficacy of colchicine in the primary prevention of the postpericardiotomy syndrome in addition to optimal standard care.

Eligibility: Inclusion Criteria:
  -  Patients in the third day after a cardiac surgery operation
  -  Age≥ 18 years
  -  Informed consent
  Exclusion Criteria:
  All evaluated before the surgical operation:
  -  Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality
  -  Serum creatinine >2.5 mg/dl
  -  Serum creatine kinase (CK) over the upper limit of normality or known myopathy
  -  Known gastrointestinal or blood disease
  -  Pregnant or lactating women or women not protected by a contraception method
  -  Known hypersensibility to colchicine
  -  Treatment with colchicine at enrolment

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients

Summary: The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.


Eligibility: Inclusion Criteria:
  -  Dialysis patients who will be receiving their first kidney transplant
  -  Weight over 88 pounds (lbs.)
  Exclusion Criteria:
  -  Very high cholesterol levels
  -  Obesity
  -  Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

Summary: Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

Detailed description: This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,
  -  To provide everolimus maintenance therapy through this access program and
  -  To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first.
  -  To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.

Eligibility: Inclusion Criteria:
  -  Male or female recipients of solid organ transplants
  -  Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis
  -  Currently on investigational drug everolimus (RAD) therapy
  Exclusion Criteria:
  -  Inability or unwillingness to comply with immunosuppressive regimen.
  -  Pregnancy.
  -  History of acute organ rejection within the last 3 months.
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients

Summary: This study will test the safety and efficacy of everolimus on heart transplant recipients.
  This study is not recruiting in the United States.


Eligibility: Inclusion Criteria:
  -  Male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
  -  Calculated creatinine clearance (Cockroft-Gault) ≥ 50 mL/min at screening.
  -  Patients who have given written informed consent to participate in the study.
  Exclusion Criteria:
  Patients who are recipients of multiple solid organ transplants or have previously received organ transplants.
  Patients who received any investigational drug or who have been treated with an immunosuppressive drug or treatment within 1 month prior to randomization Patients receiving induction therapy which is not standard per local practice Patients with donor greater than 60 years and/or with known donor coronary or heart disease at the time of transplant.
  Donor heart cold ischemic time >6 hours. Patients with Panel Reactive Antibodies >20%. Patients who are recipients of ABO incompatible transplants Patients with platelet count <50,000/mm3 at the evaluation before randomization.
  Presence of severe hypercholesterolemia (≥350 mg/dL; ≥9 mmol/L) or hypertriglyceridemia (≥750 mg/dL; ≥8.5 mmol/L) Patients with an absolute neutrophil count of ≤1,500/mm3 or white blood cell count of ≤4000/mm3 at baseline before surgery Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low dose aspirin treatment is allowed) Patients who are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable.
  Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded Patients with a known hypersensitivity to similar drugs and to the components of the formulations Patients being treated with terfenadine, astemizole, or cisapride. Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.
  Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma) Patients with clinically significant systemic infection Patients who are unable to take oral medication Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer Abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception

Relevance to patient case: not relevant
Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

Clinical trial: Adoptive Immunotherapy for CMV Disease

Summary: Treatment strategy of patients:
  Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance.
  Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD.
  Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI.
  Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization.
  Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.


Eligibility: Inclusion Criteria:
  -  For Patient:
  -  Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
  -  Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
  -  Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
  -  Patients with HLA phenotype for which a relevant peptide for CMV exists.
  -  For Donor:
  -  Consenting sibling >18 years old.
  -  HLA phenotype for which a relevant peptide for CMV exists.
  Exclusion Criteria:
  -  For Patient:
  -  Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
  -  For Donor:
  -  Consenting sibling >18 years old.
  -  HLA phenotype for which a relevant peptide for CMV exists.
  -  Donor with an infectious disease (e.g. HIV-1; HBV, etc.)

Relevance to patient case: not relevant