araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma

Summary: RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
  PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have soft tissue sarcoma.

Detailed description: OBJECTIVES:
  -  Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable soft tissue sarcoma.
  -  Describe response, tolerance to, and side effects of this regimen in these patients.
  OUTLINE: This is an open-label study.
  Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.
  Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.
  Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.
  PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed soft tissue sarcoma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy
  -  Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
  PATIENT CHARACTERISTICS:
  Age:
  -  6 months and over
  Performance status:
  -  Karnofsky 60-100%
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  WBC at least 2,000/mm^3
  -  Platelet count at least 50,000/mm^3
  Hepatic:
  -  No hepatic insufficiency
  -  Bilirubin no greater than 2.5 mg/dL
  -  SGOT and SGPT no greater than 5 times upper limit of normal
  Renal:
  -  No renal insufficiency
  -  Creatinine no greater than 2.5 mg/dL
  -  No history of renal conditions that contraindicate high dosages of sodium
  Cardiovascular:
  -  No uncontrolled hypertension
  -  No history of congestive heart failure
  -  No history of other cardiovascular conditions that contraindicate high dosages of sodium
  Pulmonary:
  -  No serious lung disease, such as chronic obstructive pulmonary disease
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception during and for 4 weeks after study participation
  -  No active infection
  -  No nonmalignant systemic disease
  -  Not high medical or psychiatric risk
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 4 weeks since immunotherapy
  -  No concurrent immunomodulating agents
  Chemotherapy:
  -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  Endocrine therapy:
  -  Concurrent corticosteroids allowed
  Radiotherapy:
  -  At least 8 weeks since prior radiotherapy
  Surgery:
  -  Recovered from prior surgery
  Other:
  -  Prior cytodifferentiating agents allowed
  -  No prior antineoplastons
  -  No other concurrent antineoplastic agents

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

Summary: RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia.
  PURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma.

Detailed description: OBJECTIVES:
  -  Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy for sarcoma.
  -  Identify patients who are at increased risk of t-MDS/AML during or after therapy.
  OUTLINE: Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy.
  Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency (glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles).
  Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
  PROJECTED ACCRUAL: A total of 321 patients will be accrued for this study within 4 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of sarcoma including:
  -  Rhabdomyosarcoma
  -  Ewing's sarcoma
  -  Primitive neuroectodermal tumor
  -  Fibrosarcoma
  -  Malignant peripheral nerve sheath tumor
  -  Synovial cell sarcoma
  -  Osteosarcoma
  -  Other soft tissue sarcoma
  -  Must be currently receiving intensive or high-dose chemotherapy for sarcoma
  PATIENT CHARACTERISTICS:
  Age:
  -  Children
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  See Disease Characteristics
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma.

Detailed description: OBJECTIVES: I. Determine the therapeutic activity of ecteinascidin 743 in patients with advanced soft tissue sarcomas. II. Determine the duration of response in these patients. III. Determine the acute side effects in these patients.
  OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 (ET-743) IV over 24 hours every 3 weeks. Treatment continues for at least 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and every 12 weeks after disease progression.
  PROJECTED ACCRUAL: Approximately 28-44 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven soft tissue sarcoma, including the following cell types: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including hemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Miscellaneous sarcoma including mixed mesodermal tumors of the uterus Cell types NOT allowed: Malignant mesothelioma Chondrosarcoma Neuroblastoma Osteosarcoma Ewing's sarcoma Embryonal rhabdomyosarcoma Measurable lesion with evidence of progression within 6 weeks prior to study (osseous lesions, hepatomegaly, lymphedema, ascites, and pleural lesions are not considered measurable) No symptomatic or known CNS metastases
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.75 mg/dL Albumin at least 2.5 g/dL AST and ALT less than 1.5 times upper limit of normal (ULN) (2.5 times ULN if liver metastasis present) Alkaline phosphatase less than 2.5 times ULN No other significant hepatic disease (e.g., active hepatitis, cirrhosis, etc.) Renal: Creatinine no greater than 1.36 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No prior cardiovascular disease Other: No other severe medical illness No psychosis No prior or concurrent second primary malignant tumors, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior regimen of combination chemotherapy OR No more than 2 prior single agent regimens No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to sole index lesion No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational drugs

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Vaccine Therapy in Treating Patients With Recurrent Soft Tissue Sarcoma

Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma.

Detailed description: OBJECTIVES: I. Determine the efficacy of autologous tumor cell-derived heat shock protein peptide vaccine in terms of the rate of complete and partial response and time to progression in patients with recurrent soft tissue sarcoma. II. Determine the safety and tolerability of this treatment regimen in this patient population. III. Determine the anti-tumor response to this treatment regimen in these patients.
  OUTLINE: At approximately 5 weeks after surgery, patients receive autologous tumor cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks. Patients receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with improving or stable disease or without recurrence continue on therapy for up to 1 year.
  PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed recurrent soft tissue sarcoma Incompletely or completely resected metastatic or locally recurrent disease (surgery must be performed with intent of complete resection) No active brain metastases
  PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: At least 16 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 80,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: No active infections requiring antibiotics within 2 weeks of study No other serious medical illness requiring hospitalization No history of primary or secondary immunodeficiency or autoimmune disease No contraindications to MRI (e.g., aneurysm clips or cardiac pacemakers) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy and recovered Chemotherapy: At least 6 weeks since prior chemotherapy and recovered Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics No prior splenectomy Other: At least 6 weeks since other prior experimental anticancer therapy and recovered No concurrent non-steroidal anti-inflammatory drugs or other immunosuppressive drugs No other concurrent participation in a clinical trial

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Genetic Study of Patients and Families With Diaphyseal Medullary Stenosis With Malignant Fibrous Histiocytoma of the Bone

Summary: OBJECTIVES: I. Identify and characterize the gene causing diaphyseal medullary stenosis with malignant fibrous histiocytoma of the bone.
  II. Determine the clinical manifestations of this disease in these patients.

Detailed description: PROTOCOL OUTLINE: Blood samples are obtained from affected individuals and their family members after genetic counseling. Genetic linkage analysis is performed on these blood samples. Unaffected individuals undergo x-rays and technetium bone scans to detect the presence of bone disease. Affected individuals undergo bone densitometry, MRI studies, thallium scans, ophthalmologic examination, electrocardiogram, echocardiogram, and skin biopsies.
  Affected family members identified after radiologic studies receive additional genetic counseling.

Eligibility: PROTOCOL ENTRY CRITERIA:
  --Disease Characteristics--
  Diagnosis of diaphyseal medullary stenosis with malignant fibrous histiocytoma of the bone
  OR
  Family member, including spouses, of an affected individual
  --Patient Characteristics--
  Renal: Not specified
  -  Not pregnant
  -  Negative pregnancy test
  -  No diminished mental capacity
  -  No prisoners

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.

Detailed description: OBJECTIVES:
  -  Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
  -  Determine the toxicity of this drug in these patients.
  OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).
  Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 2-3 months for 1 year and then annually thereafter.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:
  -  Ewing's family of tumors/primitive neuroectodermal tumor
  -  Retinoblastoma
  -  Nephroblastoma
  -  Osteosarcoma
  -  Rhabdomyosarcoma
  -  Desmoplastic small round-cell tumor
  -  Hepatoblastoma
  -  Germ cell tumors
  -  Medulloblastoma
  -  Relapsed from or resistant to prior standard anticancer therapy and/or no known standard therapy available
  -  Measurable disease (e.g., solid mass with definable dimensions) OR
  -  Evaluable disease (e.g., bone marrow involvement or malignant pleural effusion)
  PATIENT CHARACTERISTICS:
  Age:
  -  40 and under
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  Renal:
  -  Creatinine no greater than 2.5 times ULN
  Cardiovascular:
  -  Absolute QT interval no greater than 460 msec in the presence of adequate potassium and magnesium levels
  Other:
  -  No pre-existing neurotoxicity/neuropathy grade 2 or greater
  -  No pre-existing convulsive disorder
  -  No active serious infections uncontrolled by antibiotics
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  More than 3 weeks since prior cytotoxic chemotherapy
  -  No other concurrent cytotoxic chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Concurrent radiotherapy allowed provided measurable or evaluable disease exists outside radiation field
  Surgery:
  -  Not specified
  Other:
  -  No other concurrent investigational agents

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Analysis of Molecular Markers of Drug Resistance in Tumor Biopsies From Previously Untreated Aggressive Non-Hodgkin's Lymphoma

Summary: Although the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. To further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets [including but not restricted to bcl-2, BAX, bcl-6, MIB-1, p53, p21, p27, p16, cyclin D(1), cyclin A, cyclin E, mdm-2, cpp 32, mcl-1, EBER-1, ALK, and a panel of B, T and other cell lineage markers], involving these pathways, with clinical outcome following treatment with combination chemotherapy. All clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. No new patients will be enrolled for this study.

Detailed description: Although the cause(s) of clinical drug resistance in non-Hodgkin's lymphomas (NHL) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. Clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. To further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets using immunohistochemistry and cDNA microarray expression profiling (including but not restricted to bcl-2, BAX, bcl-6, MIB-1, p53, p21, p27, p16, cyclin D1, cyclin A, cyclin E, mdm-2, cpp 32, mcl-1, EBER-1, ALK, and a panel of B, T and other cell lineage markers), involving these pathways, with clinical outcome following treatment with combination chemotherapy. All clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. No new patients will be enrolled for this study.

Eligibility: Prior enrollment on the clinical trial of ProMACE-CytaBOM versus ProMACE-MOPP (81-C-0166) or Short Course ProMACE-CytaBOM (87-C-0180) for the treatment of previously untreated aggressive lymphomas.
  Informed consent for participation in the above clinical trials.
  Adequate biopsy material from initial biopsy and/or biopsies at relapse of disease.

Relevance to patient case: not relevant
Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

Clinical trial: Imatinib Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma or Bone Sarcoma

Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
  PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic or unresectable locally advanced soft tissue sarcoma or bone sarcoma.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of imatinib mesylate, as measured by response rate, in patients with metastatic or unresectable locally advanced soft tissue or bone sarcoma who have failed one or more prior treatment regimens.
  -  Determine the clinical and laboratory toxic effects of this drug in these patients.
  OUTLINE: This is a multicenter study. Patients are stratified according to disease subtype.
  Patients receive oral imatinib mesylate twice daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: A total of 60-120 patients (6-12 per stratum) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed metastatic or unresectable locally advanced (stage IV or recurrent) soft tissue or bone sarcoma
  -  Eligible subtypes:
  -  Ewing's family (e.g., primitive neuroectodermal tumor)
  -  Osteosarcoma
  -  Synovial sarcoma
  -  Rhabdomyosarcoma (e.g., alveolar, embryonal, or pleomorphic)
  -  Liposarcoma (all variants)
  -  Malignant fibrous histiocytoma
  -  Peripheral nerve sheath (e.g., malignant peripheral nerve sheath tumor, neurofibrosarcoma, or schwannoma)
  -  Fibrosarcoma
  -  Angiosarcoma (all variants)
  -  Failed standard therapy with no available salvage regimens
  -  Unidimensionally measurable target lesions by x-ray, CT scan, MRI, PET, or physical examination
  -  Must be outside prior irradiation fields or have documented disease progression at least 6 weeks after completion of prior radiotherapy
  PATIENT CHARACTERISTICS:
  Age:
  -  10 and over
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin no greater than 3 times upper limit of normal (ULN)
  -  ALT and AST less than 2.5 times ULN
  Renal:
  -  Creatinine less than 1.5 times ULN
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective barrier contraception during and for at least 1 week after study participation for female patients and for at least 3 months after study participation for male patients
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  No hormonal birth control
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 3 weeks since prior radiotherapy and recovered
  Surgery:
  -  Not specified
  Other:
  -  At least 28 days since any prior systemic therapy

Relevance to patient case: not relevant