araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 51-year-old female with papillary thyroid carcinoma; genetic feature: BRAF (V600E)

Clinical trial: BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients

Summary: Adjuvant therapy with dabrafenib plus trametinib in melanoma was approved in 2018 by the EMA (EUropean Medicines Agency).
  The purpose of this non-interventional study is to assess the usage of adjuvant dabrafenib and trametinib in clinical practice, where the patient population may differ from study population.

Detailed description: Melanoma is a disease of significant metastatic potential if not detected very early. Oncogenic mutations in BRAF (B-Raf proto-oncogene, serine/threonine kinase) are found in approximately 40% of melanomas and result in constitutive activation of the MAPK (Mitogen-Activated Protein Kinase) pathway.
  Treatment with the BRAF inhibitor dabrafenib plus the MEK (Mitogen-activated protein kinase kinase) inhibitor trametinib showed improved overall survival in patients with unresectable or metastatic BRAF V600E/K-mutant melanoma (COMBI-d and COMBI-v studies). In an adjuvant setting treatment with dabrafenib and trametinib significantly reduced the risk of melanoma recurrence in patients with high-risk, stage III BRAF V600-mutant melanoma, with improvements in OS (Overall Survival), DMFS (Distant Metastasis Free Survival), and FFR (Freedom From Relaps) (COMBI-AD study). Based on these results, adjuvant dabrafenib plus trametinib therapy was approved in 2018 by the EMA.
  Compared to the metastatic situation, issues of compliance and treatment adherence may be more relevant in adjuvant treatments, as patients are free of disease and potentially cured even without adjuvant treatment. As the routine administration of drugs including dosing, treatment interruptions, and early termination in clinical practice may vary from procedures defined in clinical trials, this study aims to assess the usage of adjuvant dabrafenib and trametinib in the routine clinical setting.

Eligibility: Inclusion Criteria:
  -  Patients with complete surgical resection of histologically confirmed AJCC (American Joint Committee on Cancer) (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) melanoma, for whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study.
  -  V600E/K mutation-positive cutaneous melanoma
  -  Adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) as indicated in the SmPC (Summary of Product Characteristics) and by prescription, that has been started no longer that 4 weeks before inclusion of the patient into the study or which will be initiated directly after inclusion
  -  Age ≥ 18 years
  -  Signed written informed consent
  Exclusion Criteria:
  -  Lack of basic demographics and staging information
  -  Current or planned participation within a clinical trial. The participation in a follow-up phase of a clinical trial without active intervention is allowed.
  -  Current or planned treatment of another tumor disease except keratoacanthoma, squamous cell or basal cell carcinoma of the skin

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

Summary: RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors.
  PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.

Detailed description: OBJECTIVES:
  -  Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy.
  -  Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes, and survival of these patients.
  OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor location (posterior fossa tumors vs all other brain tumors).
  Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3 hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection.
  Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are treated at the MTD.
  Patients are followed at 4 and 6 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
  PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of supratentorial or infratentorial brain tumor
  -  Localized, non-disseminated
  -  Primary tumor or solitary metastasis
  -  Recurrent or progressive
  -  Unresectable
  -  Negative CSF
  -  Must have failed standard therapy including radiotherapy
  -  Measurable disease as evidenced by CT scan or MRI
  -  Single or multiple masses accessible to light administration
  PATIENT CHARACTERISTICS:
  Age:
  -  3 to 70
  Performance status:
  -  Not specified
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  Absolute neutrophil count at least 1,000/mm3
  -  May transfuse platelets
  Hepatic:
  -  PT and PTT normal
  Renal:
  -  Not specified
  Other:
  -  Not pregnant
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  At least 6 weeks since prior chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  -  No prior brachytherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No other concurrent antitumor therapy

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme

Summary: RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors.
  PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme.

Detailed description: OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity.
  OBJECTIVES:
  -  To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme, as measured by an objective response to therapy (complete response, partial response or stable disease).
  -  To determine the safety and tolerance of Antineoplaston therapy in adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme.
  -  To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
  PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed Glioblastoma Multiforme
  -  Subtotal resection or biopsy only of tumor
  -  Measurable tumor by MRI scan performed within two weeks prior to study entry
  -  Tumor must be at least 5 mm
  -  No brain stem tumor
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  More than 4 months
  Hematopoietic:
  -  WBC at least 1,500/mm^3
  -  Platelet count at least 50,000/mm^3
  -  Hemoglobin at least 10 g/dL
  Hepatic:
  -  No hepatic failure
  -  Bilirubin no greater than 2.5 mg/dL
  -  SGOT and SGPT no greater than 5 times upper limit of normal
  Renal:
  -  Creatinine no greater than 2.5 mg/dL
  -  No history of renal conditions that would contraindicate high dosages of sodium
  Cardiovascular:
  -  No uncontrolled hypertension
  Other:
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior immunotherapy
  -  No concurrent immunomodulatory agents
  Chemotherapy:
  -  No prior chemotherapy
  -  No concurrent antineoplastic agents
  Endocrine therapy:
  -  Concurrent corticosteroids for cerebral edema allowed
  Radiotherapy:
  -  No prior radiotherapy
  Surgery:
  -  See Disease Characteristics
  -  Recovered from any prior surgery

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Radiation Therapy Plus Hyperbaric Oxygen in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperbaric oxygen may increase the effectiveness of radiation therapy. Combining hyperbaric oxygen with radiation therapy may be an effective treatment for glioblastoma multiforme.
  PURPOSE: Phase I/II trial to study the effectiveness of combining radiation therapy with hyperbaric oxygen in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed description: OBJECTIVES: I. Determine the feasibility and toxicity of hyperbaric oxygen combined with conformal radiotherapy in patients with newly diagnosed glioblastoma multiforme. II. Determine the efficacy of this regimen in terms of radiographic tumor response, time to tumor progression, and survival in these patients.
  OUTLINE: Within 2 weeks after surgery, patients receive hyperbaric oxygen over 90 minutes once daily, followed by conformal radiotherapy twice daily 5 days a week for 17 days in the absence of unacceptable toxicity. Patients are followed within 2 weeks and then every 2 months thereafter.
  PROJECTED ACCRUAL: A total of 5-10 patients will be accrued for this study within 1 year.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven newly diagnosed glioblastoma multiforme Measurable residual tumor by MRI after biopsy or craniotomy
  PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: More than 8 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No severe pulmonary disease (e.g., emphysema with carbon dioxide retention) No untreated pneumothorax Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except epithelial skin cancer No psychological, familial, sociological, or geographical conditions that would preclude study No intractable seizure disorder
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent bleomycin Endocrine therapy: Not specified Radiotherapy: No prior cranial radiotherapy Surgery: See Disease Characteristics Other: No other prior therapy, including adjuvant therapy, for glioblastoma multiforme

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Motexafin Gadolinium Plus Radiation Therapy to the Brain in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make tumor cells more sensitive to radiation therapy.
  PURPOSE: Phase II trial to study the effectiveness of motexafin gadolinium plus radiation therapy to the brain in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed description: OBJECTIVES: I. Assess the safety of motexafin gadolinium and cranial irradiation, in terms of dose-limiting toxicity and clinically significant adverse events, in patients with newly diagnosed glioblastoma multiforme. II. Evaluate the pharmacokinetics of this regimen in these patients. III. Determine the survival of patients treated with this regimen. IV. Assess the activities of daily living and neurological status of patients treated with this regimen.
  OUTLINE: This is a multicenter study. Patients receive motexafin gadolinium IV over 30 minutes on days 1-5 of weeks 1 and 2, and on days 1, 3, and 5 of weeks 3-6. Patients undergo cranial irradiation on days 1-5 of weeks 1-6. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo a neurological examination and an activities of daily living questionnaire at baseline, week 10, and during follow-up visits. Patients are followed at weeks 10 and 16 and then every 2 months thereafter.
  PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme (GBM) Grade IV astrocytoma Located supratentorially At least 2 weeks and no more than 4 weeks since prior surgery for GBM No recurrent disease
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL AST and ALT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: HIV negative No history of porphyria No glucose-6-phosphate dehydrogenase deficiency No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior antineoplastic agent for GBM No concurrent chemotherapy during and for 2 weeks after study No other concurrent antineoplastic investigational agent Endocrine therapy: Prior and concurrent corticosteroids allowed Radiotherapy: No prior radiotherapy to the brain Surgery: See Disease Characteristics Other: Concurrent anticonvulsants allowed Other concurrent cancer therapy allowed if medically necessary

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Efficacy of Distant Healing in Glioblastoma Treatment

Summary: This study will assess whether distant healing effects survival time and loss of function for glioblastoma patients.

Detailed description: Prayer, energy healing, and spiritual healing are widely used for all degrees of illness.
  Eisenberg (1998) reported that more that 26% of his survey sample used "energy healing" within the last year. Most of these practitioners believe that their inner intentions result in the benefits, either through the agency of love, energy, or a Higher Power (Benor 1992). However, the conventional community attributes benefits from these interventions to the patient's hope, expectation, or experience of support from a practitioner (Benson 1996). The proposed study is a double-blind randomized controlled clinical trial of "distant healing intentionality." Distant Healing (DH) is defined as a "mental intention on behalf of one person, to benefit another at a distance." This study will assess whether DH effects survival time and loss of function for glioblastoma patients under conditions where hope and expectation are controlled. The study will include approximately 150 patients who have rapidly progressing glioblastoma and are beginning radiotherapy. Patients will be photographed and assessed for quality of life, psychological status, and physical symptoms as well as health habits and attitude toward DH. After stratification by age and functional status (Karnofsky score), patients will be randomly assigned to either standard treatment with or without DH. Healers from diverse schools and backgrounds from communities across the United States will be assigned to patients by rotation, so that each patient in the DH group will be treated for two weeks by 10 different healers over the 20 week intervention. Experienced healers will have photographs of subjects and send "mental intention for health and well being" to subjects for one hour daily, three times per week. The healing intervention will be performed at a distance, and patients and healers will never meet, nor will patients know their group assignment. The study findings will provide the basis for developing a larger study, definitive trial.

Eligibility: Inclusion:
  -  Histologically confirmed diagnosis of glioblastoma based on open resection.
  -  Patient is within five weeks of diagnosis confirmed by pathology report.
  Exclusion:
  -  Non-English speaking.
  -  Inability or unwillingness to fill out questionnaires.
  -  History of other cancers within the last 2 years (except superficial basal cell, squamous cell carcinoma of the skin), or other concurrent life-threatening conditions.

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain

Summary: RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue.
  PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.

Detailed description: OBJECTIVES:
  -  Determine the time course, uniformity, and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex (BPA-f) followed by cranial neutron irradiation using a new fission converter beam facility.
  -  Determine the maximum tolerated dose of cranial neutron capture therapy in these patients.
  -  Determine, through serial objective measurements, the clinical response in patients treated with this therapy.
  -  Determine the pharmacokinetics of BPA-f in these patients.
  OUTLINE: This is a dose-escalation study of cranial neutron capture therapy (NCT).
  Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2.
  Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.
  Patients are followed at 1, 2, 4, 6, 9, and 12 months and then every 6 months for 2 years.
  PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed glioblastoma multiforme OR
  -  Radiographically diagnosed brain metastases after a diagnosis of melanoma
  -  Contrast-enhanced tumor volume must not exceed 60 mL
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  At least 6 months
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Creatinine normal
  Cardiovascular:
  -  No prior severe cardiac disease, including the following:
  -  Uncontrolled arrhythmias or conduction defects
  -  Unstable or newly diagnosed angina pectoris
  -  Recent coronary artery disease
  -  Congestive heart failure
  Other:
  -  Not pregnant
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for at least 6 months after study
  -  No prior phenylketonuria
  -  No cognitive impairment that would preclude informed consent
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No concurrent chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No prior cranial irradiation
  Surgery:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma

Summary: The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma


Eligibility: Inclusion Criteria:
  -  Glioblastoma
  -  Karnofsky Performance Status ≥ 60%
  Exclusion Criteria:
  -  Severe or uncontrolled systemic disease
  -  Active auto-immune disease
  -  Uncontrolled epilepsia
  -  Platelets < 100 000/mm3 ; or Neutrophils <500 /mm3 ; or lymphocytes <300/ mm3

Relevance to patient case: not relevant
Patient case: 50-year-old male with glioblastoma; genetic feature: IDH1 (R132H)

Clinical trial: Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research

Summary: This study aims to determine effectiveness of Gefitinib (Iressa) in recurrent glioblastoma after standard treatment (surgery, radiationtherapy and at least a first line chemotherapy). Gefitinib is a specific inhibitor of the epidermal growth factor receptor (EGFR). EGFR is elevated in more than 50% of malignant gliomas. At recurrence, secondary surgery and pre- and postoperative Gefitinib is offered to patients in good performance status. Clinical outcome of patients and correlation to translational research will be evaluated.

Detailed description: Glioblastoma (GBM) patients who relapse and are in good performance status, without serious neurological deficits are offered secondary surgery and participation in the trial. Eligible patients must have had standard treatment including primary surgery, radiation therapy and at least a first line chemotherapy. Patients on cytochrome P450 isoenzyme CYP3A4-inducing antiepileptic drugs (EIAE) are excluded due to ensuing interactions of these drugs with gefitinib metabolism, reducing systemic availability. After giving written informed consent, patients receive gefitinib 500 mg daily starting at least 5 days prior to re-operation, allowing a steady state condition.Treatment continues until tumor progression or occurrence of intolerable side effects.The specimens collected at surgery will undergo translational research, aiming to correlate drug accumulation and molecular signatures of GBM samples with clinical outcome.

Eligibility: Inclusion Criteria:
  -  recurrent glioblastoma
  -  informed consent
  -  reoperation planned
  -  fresh frozen sample obtainable
  Exclusion Criteria:
  -  enzyme inducing antiepileptic drugs
  -  pregnancy or breast feeding

Relevance to patient case: not relevant