araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 56-year-old female with gastrointestinal stromal tumor; genetic feature: PDGFRA (D842V)

Clinical trial: Early Access Program (EAP) for Avapritinib in Patients With Locally Advanced Unresectable or Metastatic GIST

Summary: This is a US, multicenter, open-label expanded access program to provide access to avapritinib until such time that avapritinib becomes available through other mechanisms or the Sponsor chooses to discontinue the program.


Eligibility: Inclusion Criteria:
  1. Patient is ≥ 16 years of age.
  2. Diagnosis of unresectable or metastatic GIST
  3. The patient is not eligible for an ongoing study of avapritinib or cannot access an ongoing study of avapritinib.
  4. Patient has received 3 or more TKI therapies including imatinib, or the patient has GIST that carries a mutation in exon 18 of the PDGFRA gene (such as D842V).
  5. The patient has adequate vital organ function, including heart, lungs, liver, kidneys, bone marrow and endocrine, and is expected to tolerate therapy with a TKI.
  6. Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.
  Exclusion Criteria:
  1. Patients who have poor organ function as defined by one or more of the following laboratory parameters;
  1. Total bilirubin > 2 × ULN; or > 3 × ULN in the presence of Gilbert's Disease;
  2. Platelet count < 75 × 10^9/L.
  2. Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4
  3. Patient has had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days of the first dose of avapritinib.
  4. Patient has a history of a cerebrovascular accident or transient ischemic attacks within 1 year prior to the first dose of program drug.
  5. Patient has a known risk of intracranial bleeding, such as a brain aneurysm or history of subdural or subarachnoid bleeding.
  6. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib.
  7. Women who are pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 7 days before the randomization. Females with β-hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the Sponsor, after pregnancy has been ruled out. Females of non- childbearing potential (postmenopausal for more than 1 year; bilateral tubal ligation; bilateral oophorectomy; hysterectomy) do not require a serum β-hCG test.
  8. Women who are breast feeding.

Relevance to patient case: definitely relevant
Patient case: 56-year-old female with gastrointestinal stromal tumor; genetic feature: PDGFRA (D842V)

Clinical trial: Jejunoileal vs Gastric GIST in the Era of Imatinib.

Summary: Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib.
  Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.


Eligibility: Inclusion Criteria:
  -  Any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST.
  Exclusion Criteria:
  -

Relevance to patient case: possibly relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with multiple myeloma.

Detailed description: OBJECTIVES: I. Assess the toxicity and efficacy at the maximum tolerated dose of busulfan, melphalan, and thiotepa in patients with multiple myeloma.
  OUTLINE: This is a single arm, open label study. Peripheral blood stem cells (PBSC) are collected and cryopreserved, or bone marrow is harvested and stored, until infusion on day 0. Patients receive oral busulfan every 6 hours on days -8, -7, and -6. Melphalan is administered by continuous IV infusion over 30 minutes on days -5 and -4. Thiotepa is administered by continuous IV infusion over 2 hours on days -3 and -2. Patients undergo PBSC or bone marrow infusion 36-48 hours following the completion of chemotherapy (day 0). Patients are followed for 100 days posttransplant and every 3 months thereafter.
  PROJECTED ACCRUAL: 30 patients will be accrued.

Eligibility: DISEASE CHARACTERISTICS: Histologically diagnosed stage II/III multiple myeloma (or have greater than normal beta-2-microglobulin) meeting the Salmon and Durie criteria Stage I multiple myeloma must have had prior chemotherapy before undergoing transplantation
  PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine clearance at least 50 mg/min Cardiovascular: Left ventricular ejection fraction at least 41% Other: Not pregnant HIV negative
  PRIOR CONCURRENT THERAPY: Not specified

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Melphalan and Filgrastim to Stimulate Peripheral Stem Cells in Patients With Multiple Myeloma

Summary: RATIONALE: Melphalan and colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood.
  PURPOSE: Phase II trial to study the effectiveness of melphalan combined with filgrastim in stimulating peripheral stem cells in patients who have multiple myeloma.

Detailed description: OBJECTIVES:
  -  Determine the safety and efficacy of melphalan when used with filgrastim (G-CSF) for stem cell mobilization in patients with multiple myeloma.
  -  Analyze how this mobilization regimen affects parameters of stem cell (CD34+) mobilization and collection in these patients.
  -  Determine how this mobilization regimen affects disease status and clonotypic (i.e., tumor cell) contamination in stem cell components in these patients.
  OUTLINE: Patients undergo peripheral blood stem cell (PBSC) mobilization consisting of melphalan IV on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until PBSC collection is complete.
  Patients are followed at 1 month.
  PROJECTED ACCRUAL: A total of 11-32 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of multiple myeloma
  -  Must have received induction therapy within the past 3 months
  -  Chemoresponsive disease
  -  Greater than 50% reduction of monoclonal paraprotein with reduction in marrow plasma cell infiltrate or greater than 50% reduction in marrow plasma cell infiltrate if disease is non-secretory
  -  No symptomatic pleural effusions
  -  Eligible for stem cell transplantation
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-3 (ECOG 3 allowed only if due to bone disease or neuropathy)
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Platelet count at least 150,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 2.5 mg/dL
  Renal:
  -  Creatinine no greater than 2.5 mg/dL OR
  -  Creatinine clearance greater than 51 mL/min
  Cardiovascular:
  -  No symptomatic cardiomyopathy
  -  No medically documented symptomatic cardiac arrhythmias within the past 60 days
  -  No New York Heart Association class III congestive heart failure
  -  No myocardial infarction within the past 6 months
  Other:
  -  No other concurrent medical conditions that would preclude study
  -  No uncontrolled infections
  -  No other active malignancy within the past 5 years except for non-melanoma skin cancer
  -  Not pregnant
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior stem cell mobilization or transplantation
  Chemotherapy:
  -  See Disease Characteristics
  -  No more than 200 mg prior oral melphalan
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No more than 3000 cGy of prior radiotherapy for myeloma
  Surgery:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Thalidomide for Multiple Myeloma

Summary: The objective of this protocol is to assess therapeutic activity of thalidomide in previously untreated patients with asymptomatic multiple myeloma.

Detailed description: This study attempts to examine the potential efficacy of thalidomide in the treatment of patients with previously untreated multiple myeloma. The trial focuses on patients with asymptomatic and indolent disease who do not require immediate chemotherapy. We intend to treat asymptomatic patients with an initial dose of 200 mg each evening, increasing to a maximum of 800 mg.
  Thalidomide is supplied as 50 mg capsules to be taken by mouth. The initial dose will be 200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion) daily provided there are no side effects.
  Patients who experience significant toxicity (grade 2 or more) at any time during therapy will receive a lower dose after treatment is interrupted for at least 2 days.
  Once a maximum tolerated dose has been reached free of side effects, that dose will be continued for a total of 3 months from institution of therapy before definition of response or resistance. Only patients who have received at least 200 mg/d for at least 2 months will be considered evaluable for response. For patients in remission, treatment will be continued at the maximum dose free of side effects until relapse. Selected patients <55 years of age who achieve remission may be eligible for stem cell transplant (SCT) in which case thalidomide will be discontinued prior to SCT.
  Patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals.

Eligibility: -  Previously untreated patients with multiple myeloma and without serious or imminent complications (e.g. impending pathologic fracture, hypercalcemia, renal insufficiency). All asymptomatic patients with low or intermediate tumor mass will qualify.
  -  Patients with high tumor mass, symptomatic or impending fractures, hypercalcemia (corrected calcium >11.5 mg%), anemia (Hgb <8.5 gm/dl), renal failure (creatinine >2.0 mg/dl), high serum lactate dehydrogenase (>300 U/L) or plasma cell leukemia (>1000/ul) are ineligible.
  -  Overt infections or unexplained fever should be resolved before treatment. Adequate liver function (including SGPT, bilirubin and LDH) is required.
  -  Patients must have Zubrod performance of 1 or less.
  -  Patients must provide written informed consent indicating that they are aware of the investigational nature of this study.
  -  Life expectancy should exceed 1 year.
  -  Patients with idiopathic monoclonal gammopathy and non-secretory multiple myeloma are ineligible. Patients whose only prior therapy has been with local radiotherapy, alpha-IFN, or ATRA are eligible. Patients exposed to prior high-dose glucocorticoid or alkylating agent are not eligible.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Summary: Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

Detailed description: PRIMARY OBJECTIVES:
  I. Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.
  II. Determine the toxicity of this drug in these patients.
  SECONDARY OBJECTIVES:
  I. Determine change in lesion size in these patients after treatment with this drug.
  II. Compare histologic response before and after treatment with this drug in these patients.
  OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
  Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.
  Arm II: Patients receive standard care.
  At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
  Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed grade III cervical intraepithelial neoplasia
  -  Confirmed by biopsy or colposcopy
  -  Positive for human papilloma virus 16
  -  No endocervical glandular dysplasia
  -  No adenocarcinoma in situ
  -  Performance status - GOG 0-2
  -  No life-threatening or serious hematological disorder
  -  No life-threatening or serious hepatic disorder
  -  No life-threatening or serious renal disorder
  -  No life-threatening or serious cardiac disorder
  -  No life-threatening or serious respiratory disorder
  -  HIV negative
  -  Must be immunocompetent
  -  No history of autoimmune disease
  -  No life-threatening or serious immunological disorder
  -  No prior or concurrent severe allergic disease
  -  No concurrent human papilloma viral infection other than type 16
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No life-threatening or serious gastrointestinal disorder
  -  No life-threatening or serious endocrine disorder
  -  No invasive malignancy within the past 5 years except nonmelanoma skin cancer
  -  No concurrent chronic or systemic steroids
  -  No prior organ transplantation
  -  No prior cancer therapy that would preclude study therapy

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma

Summary: The purpose of this research is to study how helpful thalidomide is in controlling the myeloma disease and to study any side effect resulting from thalidomide.

Detailed description: Patients will receive thalidomide in the oral form (by mouth). Then the dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects. After week 7, patients will continue to receive thalidomide as long as there is no toxicity requiring the treatment to be stopped and as long as there is no evidence of rapid tumor growth during the treatment with thalidomide.
  Routine physical examinations and blood tests will be done to monitor the effect of treatment and the toxicities encountered, if any, and provide the available treatments for side effects accordingly. Blood tests will be done once a month for the first six months of receiving thalidomide.

Eligibility: Inclusion Criteria:
  -  All patients must have a confirmed diagnosis of previously treated, active multiple myeloma
  -  Myeloma protein should be evident from which to evaluate response
  -  Must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
  -  Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug
  -  Patients must have a total white blood cell count of 2,000 K/microliters. Patients may be anemic or thrombocytopenic provided this is felt to be due to extensive marrow involvement with myeloma
  -  Patients must have adequate liver function as demonstrated by a direct bilirubin of < or = 2.0 mg/dL.
  Exclusion Criteria:
  -  Patients must not have an active infection requiring parenteral antibiotics
  -  No other concurrent therapy for myeloma is permitted while on Thalidomide

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

Summary: The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.

Detailed description: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.
  This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Eligibility: Inclusion Criteria:
  -  Diagnosis of multiple myeloma in first or second complete or partial remission
  -  >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
  -  Recovered from all acute toxic effects of prior chemotherapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  White Blood Cell count (WBC) > 2.5*10^9/L
  -  Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L
  -  Platelet (PLT) > 100*10^9/L
  -  Serum creatinine <=2.2 mg/dL
  -  Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
  -  Negative for HIV
  Exclusion Criteria):
  -  Failed previous stem cell collection
  -  Previous stem cell transplantation
  -  Brain metastases or myelomatous meningitis
  -  Radiation to ≥ 50% of the pelvis
  -  Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
  -  Received bone-seeking radionuclides (e.g. holmium)
  -  A residual acute medical condition resulting from prior chemotherapy

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)

Summary: The purposes of this study are:
  -  To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma;
  -  To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.


Eligibility: Inclusion Criteria:
  -  Adult patients with refractory or relapsed multiple myeloma, ECOG performance status 0-2 (ECOG)
  -  Adequate bone marrow reserve
  -  Adequate hepatic and renal function
  -  Ability to swallow capsules
  -  3 weeks or more from prior chemotherapy and have recovered from prior toxicities
  Exclusion Criteria:
  -  Patients who plan to go for bone marrow transplant within 4 weeks of start of treatment
  -  Patients with prior treatment with other investigational agents with a similar anti-tumor mechanism
  -  Patients with other active/uncontrolled clinically significant illnesses
  -  Pregnant or nursing female patients

Relevance to patient case: not relevant