araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

Summary: [Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.
  [Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy


Eligibility: [Inclusion Criteria]
  -  Provision of informed consent prior to any study specific procedures
  -  Men and women aged at least 18 years
  -  Small cell lung cancer harboring RICTOR amplification
  -  Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks
  -  Minimum life expectancy of 12 weeks
  -  Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:
  -  At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.
  -  No history of non-autologous bone marrow transplant.
  Exclusion Criteria:
  -  Participation in another clinical study with an investigational product during the last 21 days.
  -  Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
  -  Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
  -  Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
  -  Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
  -  Any haemopoietic growth factors within 14 days prior to receiving study treatment.
  -  Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
  -  Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities

Summary: Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.

Detailed description: Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.

Eligibility: Patients must have biopsy-proven soft tissue sarcoma with one of the following diagnoses:
  Liposarcoma (round cell or pleomorphic).
  Fibrosarcoma.
  Malignant fibrous histiocytoma.
  Inflammatory malignant fibrous histiocytoma.
  Myxoid malignant fibrous histiocytoma.
  Malignant giant cell tumor.
  Angiomatoid malignant fibrous histiocytoma.
  Leiomyosarcoma.
  Malignant hemangiopericytoma.
  Rhabdomyosarcoma (embryonal, alveolar, pleomorphic or combined).
  Soft tissue sarcoma resembling Ewing's sarcoma.
  Synovial cell sarcoma.
  Epithelioid sarcoma.
  Clear cell sarcoma.
  Neurofibrosarcoma.
  Epithelioid schwannoma.
  Malignant triton tumor.
  Angiosarcoma.
  Mixed malignant mesenchymoma.
  Alvelar soft part sarcoma.
  Malignant granular cell tumor.
  All lesions must be Grade II or III. No patients with Grade I lesions will be acceptable.
  Patients must have undergone a limb-sparing procedure in which all gross tumor has been removed.
  Clinical evaluation must reveal no evidence of metastatic disease either in regional lymph nodes or more distant sites.
  The soft tissue sarcoma must be on the extremity either at or distal to the shoulder joint or at or distal to the hip joint.
  The definitive surgical procedure for a primary lesion or for a recurrence must have been performed no longer than four months from the date of randomization.
  Patients must not have received any prior chemotherapy or radiotherapy for their sarcoma.
  Patients without a history of any other malignant disease except basal cell carcinoma.
  Patients who have not had a serious infection, active bleeding disorders, or concomitant severe disease such as cirrhosis, ischemic heart disease, or evidence of severe impairment of renal function.
  Patients must be above the age of 30 and do not have a diagnosis of embryonal rhabdomyosarcoma.

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors

Summary: Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.

Detailed description: This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.
  Arm I: Radiotherapy. Involved-field irradiation.
  Arm II: No further treatment.

Eligibility: DISEASE CHARACTERISTICS:
  Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:
  Abdominal and extra-abdominal fibromatosis (desmoid,
  aggressive fibromatosis),
  Dermatofibrosarcoma protuberans,
  Intramuscular lipoma (infiltrating lipoma),
  Diffuse lipomatosis,
  Leiomyoma of deep soft tissue,
  Diffuse giant cell tumor of tendon sheath (proliferative synovitis).
  No clinical evidence of metastases in regional nodes or more distant sites.
  No primary intraperitoneal or retroperitoneal tumors.
  Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).
  No von Recklinghausen's disease.
  PRIOR/CONCURRENT THERAPY:
  Biologic Therapy: Not specified.
  Chemotherapy: No prior chemotherapy for sarcoma.
  Endocrine Therapy: Not specified.
  Radiotherapy: No prior radiotherapy for sarcoma.
  Surgery: No more than 4 months since definitive surgery for
  primary lesion or recurrence.
  No prior amputation.
  PATIENT CHARACTERISTICS:
  Age: 18 and over.
  Performance status: Not specified.
  Hematopoietic: Not specified.
  Hepatic: No cirrhosis.
  Renal: No evidence of severe renal impairment.
  Cardiovascular: No ischemic heart disease.
  OTHER:
  No prior malignancy except basal cell carcinoma.
  No serious infection.
  No active bleeding disorder.
  No severe concomitant disease.

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients With CD4 <= 500 Cells/mm3

Summary: To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).

Detailed description: This is an open-label, randomized, pilot, Phase II study of the safety and efficacy of Viracept in combination with modified antiretroviral therapy as treatment in patients with cutaneous and mucosal KS. Patients will be randomized to modify (add or switch or initiate) their current antiretroviral therapy and will add Viracept or remain on their current background antiretroviral therapy for a 2 month period. Initially 20 patients will be randomized in a 2:1 ratio (i.e., 14 Viracept, 6 control) for a 2 month period. Response to therapy will be evaluated at the end of the 2 month control phase. At this point, patients who were initially assigned to the control arm will continue on open label Viracept for an additional 10 month period.

Eligibility: Inclusion Criteria
  Patients must have:
  -  HIV-positivity.
  -  Diagnosed KS proven by biopsy.
  -  NOTE:
  -  Patients must not opt for immediate topical, systemic or radiation treatment.
  -  At least 4 cutaneous lesions not treated within the previous 4 weeks.
  -  Life expectancy > 6 months.
  -  Signed, informed consent from parent or legal guardian for those patients < 18 years of age.
  Exclusion Criteria
  Co-existing Condition:
  Patients with the following conditions and symptoms are excluded:
  -  Neoplastic disease (excluding KS) requiring systemic cytotoxic or radiation therapy or who have had these therapies within 1 month of baseline and have not completely recovered from the effects of these therapies.
  -  Unstable or severe intercurrent medical conditions, including but not limited to, significant symptomatic visceral KS.
  -  Clinically significant malabsorption syndrome.
  -  Renal insufficiency.
  Patients with any of the following prior conditions are excluded:
  Significant Fever (> 101 degrees F (38 degrees C) for >= 7 days) and/or diarrhea (> 6 loose stools/day for >= 7 days) within one month of baseline.
  1. Immediate topical or systemic treatment for KS lesions.
  -  Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day concurrently.
  Immediate radiation treatment.
  1. Treatment of KS lesions with intra-lesional chemotherapy within 4 weeks of entry.
  -  History of > 2 weeks of prior therapy with Indinavir or Ritonavir.
  -  Use of Retinoid class drugs, either topically or systemically, or beta-carotene compounds or Vitamin A doses of more than 15,000 IU (5,000 mcg) per day within 4 weeks of entry.
  Treatment of KS lesions with radiation within 4 weeks of entry. Active substance abusers; urine drug tests may be performed if drug abuse is suspected.

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: Cryosurgery in Treating Patients With Soft Tissue Sarcoma

Summary: RATIONALE: Cryosurgery kills cancer cells by freezing them. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cryosurgery with chemotherapy may kill more tumor cells.
  PURPOSE: Phase I trial to study the effectiveness of cryosurgery with or without chemotherapy in treating patients who have soft tissue sarcoma.

Detailed description: OBJECTIVES: I. Assess the safety and morbidity associated with cryosurgical ablation in patients with soft tissue sarcomas of the extremity.
  OUTLINE: All patients undergo 1 session of cryoablation. Patients with high-grade sarcoma receive systemic chemotherapy 10-14 days after cryoablation at the discretion of the consulting medical oncologist, and undergo surgery 2-3 weeks following chemotherapy. Patients with low-grade sarcoma and those with high-grade sarcoma who do not receive chemotherapy undergo surgery 4-6 weeks after cryoablation. Surgery for all patients consists of en bloc resection or amputation, with limb salvage attempted when feasible. Patients are followed weekly for 3 weeks.
  PROJECTED ACCRUAL: A total of 12 patients (approximately 6 patients with low-grade, high-risk sarcoma and 6 with high-grade sarcoma) will be entered over approximately 6 months. The study will be suspended for the following: vascular complication that requires surgical intervention for correction in 2 patients; any neuropraxia that shows no evidence of resolution after 3 months in 2 patients; any wound complication that requires surgical correction in 4 patients; or any deep wound infection that requires surgical drainage in 4 patients.

Eligibility: DISEASE CHARACTERISTICS: Biopsy-proven soft tissue sarcoma (STS) of the extremity Review by Pathology Department of the University of Southern California CT or MRI required prior to biopsy Disease in one of the following categories: High-grade tumor Low-grade tumor at high risk for local recurrence, i.e.: Adjacent to bone or vital neurovascular structures and able to be removed with a minimal surgical margin (i.e., plane of dissection goes through reactive zone of tumor) Lesion more than 5 cm in diameter The following tumors exclude: Primary sarcoma of the bone Metastatic carcinoma STS of the head and neck Visceral STS, e.g., breast, uterus, spermatic cord, mediastinum chest wall STS of the pelvis or retroperitoneum
  PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Hematopoietic: WBC at least 3,000 Platelets at least 75,000 Hemoglobin at least 9 g/Dl Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times normal Renal: Not specified Other: No concurrent disease that renders patient medically or psychologically unable to tolerate treatment
  PRIOR CONCURRENT THERAPY: At least 30 days since therapy for sarcoma

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: Troglitazone in Treating Patients With Liposarcoma

Summary: Troglitazone may help liposarcoma cells develop into normal cells. This was a single arm, open-label study with a two-stage design to evaluate troglitazone in patients with liposarcoma stratified by histologic subtype.

Detailed description: OBJECTIVES:
  I. To evaluate the clinical activity of troglitazone in patients with malignant liposarcoma stratified by histologic subtype.
  II. To perform correlative imaging, biological, and biochemical testing of patients in order to define the degree to which in vivo terminal differentiation may be promoted by this therapeutic intervention.
  III. To evaluate the tolerance and safety of troglitazone in this patient population.
  PROJECTED ACCRUAL:
  Initially, 14 patients of each of the 5 histologic subtypes of liposarcoma will be accrued. If 1 or more patients show evidence of biological response, an additional 16 patients of each subtype will be accrued for a total of 30 patients per subtype. If 4 or more of 30 patients achieve biological response then troglitazone will be deemed promising in that histologic subtype.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven liposarcoma that is incurable by standard surgery Measurable or evaluable disease required No active CNS involvement or leptomeningeal disease
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT less than 5 times upper normal limit Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No poorly controlled atrial arrhythmias, angina pectoris, or myocardial infarction within past 6 months No symptomatic congestive heart failure, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within past 3 months Other: Not pregnant or nursing Fertile patients must use effective contraception No known active retroviral disease
  PRIOR CONCURRENT THERAPY: Recovered from toxic effects of all prior therapy No concurrent cytotoxic therapy Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiation therapy for metastatic disease allowed No radiotherapy to sole site of measurable disease within past 6 months Surgery: Not specified

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer

Summary: The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

Detailed description: This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.

Eligibility: Inclusion Criteria:
  -  Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
  -  Have a pathology specimen available for centralized review
  -  Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion
  -  Have adequate bone marrow, liver and kidney function
  -  Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  Exclusion Criteria:
  -  Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
  -  Cancer that has metastasized (spread) to the central nervous system
  -  Active viral hepatitis or chronic liver disease
  -  Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment
  -  History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment

Relevance to patient case: not relevant
Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer

Summary: The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult male participants with advanced metastatic (spread of cancer cells from one part of the body to another) prostate cancer.

Detailed description: This is an open-label (all people know the identity of the intervention), non-randomized, multi-center and Phase 2 study in adult male participants with advanced metastatic prostate cancer. The study consists of 3 parts: Screening (consists of 14 days before study commences on Day -1); Treatment (consists of 4-week dosing cycles wherein trabectedin will be administered as intravenously at a dose of either 0.58 milligram per square meter [mg/m^2] weekly 3-hour infusion, or 1.5 mg/m^2 or 1.2 mg/m^2 every three weeks 24-hour infusion); and Follow-up (until survival after the first dose of trabectedin). Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from trabectedin. Efficacy will be evaluated primarily through decline in prostate-specific antigen (substance in blood that is measured to check for prostate cancer) after 72 hours of therapy on Day 1. Participants' safety will be monitored throughout the study.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of the prostate
  -  Radiographically documented metastatic disease
  -  Surgical or chemical castration
  -  Prostate-specific antigen greater than or equal to (>=) 5 nanogram per milliliter (ng/ml)
  -  Eastern Cooperative Oncology Group performance status of 0, 1, or 2
  -  Androgen Independent disease
  Exclusion Criteria:
  -  Treatment with chemotherapy or radiation therapy that was terminated at least 4 weeks before study entry
  -  Treatment with extensive external beam radiation therapy or radionuclide therapy within 6 weeks of study entry (palliative radiation involving less than 20 percent of bone marrow reserves must have been completed at least 4 weeks before study entry)
  -  Participant not employing adequate contraception
  -  Other serious illness or medical conditions as : Uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within six months preceding registration; active infectious process; chronic active liver disease, including chronic Hepatitis B, chronic Hepatitis C, or cirrhosis

Relevance to patient case: not relevant