araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

Summary: Patients with metastatic melanoma who are HLA-A201+ will be immunized with a modified peptide from the gp100 molecule that contains a signal sequence designed to improve peptide presentation by antigen presenting cells. This peptide called gp100:ES209-217 (210M) will be administered either alone or in combination with high or low dose IL-2. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.

Detailed description: Patients with metastatic melanoma who are HLA-A201+ will be immunized with a modified peptide from the gp100 molecule that contains a signal sequence designed to improve peptide presentation by antigen presenting cells. This peptide called gp100:ES209-217 (210M) will be administered either alone or in combination with high or low dose IL-2. Patients will be evaluated for clinical response, as well as undergo studies of the immunologic response to the peptide immunization.

Eligibility: Any patient age greater than or equal to 18 with measurable metastatic melanoma who has failed standard treatment and has an expected survival of greater than three months will be considered.
  Serum creatinine of 2.0 mg/dl or less.
  Bilirubin 1.6 mg/dl or less.
  WBC 3000/mm(3) or greater.
  Platelet count 90,000 mm(3) or greater.
  Serum AST/ALT less then two times normal.
  ECOG performance status of 0 or 1 or 2.
  Patients of both genders must be willing to practice effective birth control during this trial.
  No patients who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer.
  No patients who have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease. Patients with cardiovascular disease will be eligible to receive peptide in IFA alone.
  No patients who require steroid therapy.
  No patients who are pregnant (because of possible side effects on the fetus).
  No patients who are known to be positive for hepatitis BsAG or HIV antibody (because of possible immune effects of these conditions).
  No patients who have any form of primary or secondary immunodeficiency. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma

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 transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
  PURPOSE: Clinical trial to study the effectiveness of chemotherapy plus bone marrow transplantation in treating patients with metastatic melanoma that has not responded to previous therapy.

Detailed description: OBJECTIVES: I. Determine the response rate and survival of patients with metastatic malignant melanoma who have failed first-line therapy when treated with match-related allogeneic bone marrow transplantation.
  OUTLINE: This is a pilot study. Patients receive a preparative regimen of busulfan and cyclophosphamide. Busulfan PO is administered every 6 hours on days -7 to -4. Cyclophosphamide IV is administered on days -3 to -2 followed by one day of rest. Bone marrow infusion occurs on day 0. Cyclosporine begins on day -1 and continues until day 180. Methotrexate IV is administered on days 1, 3, 6, and 11. Granulocyte colony-stimulating factor is administered as a continuous IV every 2 hours starting on day 12 and continuing until absolute neutrophil count is greater than 1,000 g/dL for 2 consecutive days. Patients receive weekly follow up for the first 180 days and monthly thereafter. Patients are followed until death.
  PROJECTED ACCRUAL: 6 patients with melanoma will be accrued.

Eligibility: DISEASE CHARACTERISTICS: Biopsy proven relapsed malignant melanoma that has failed prior standard regimen for metastatic disease Must have HLA-matched or related bone marrow donor (5- or 6-antigen match) No history of CNS metastases
  PATIENT CHARACTERISTICS: Age: 16 to 44 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: SGOT and SGPT less than 1.5 times upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL AND/OR Creatinine clearance greater than 75 mL/min Cardiovascular: No history of cardiac disease No symptomatic cardiac disease Ejection fraction greater than 50% Pulmonary: FEV1 greater than 50% predicted (greater than 75% if received thoracic irradiation) DLCO greater than 50% predicted Other: Not pregnant Fertile women must use effective contraception HIV negative No active bacterial, fungal, or viral infection Hepatitis B negative
  PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis

Summary: OBJECTIVES:
  I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years.
  Patients are followed regularly for unacceptable toxicities.
  Completion date provided represents the completion date of the grant per OOPD records

Eligibility: PROTOCOL ENTRY CRITERIA:
  --Disease Characteristics--
  Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5)
  No family history of male osteoporosis
  No other metabolic bone disease
  --Prior/Concurrent Therapy--
  Endocrine therapy:
  -  No concurrent glucocorticoid therapy
  -  No prior steroid use
  Surgery: No prior gastrointestinal tract surgery
  Other: No prior or concurrent anticonvulsant therapy
  --Patient Characteristics--
  Hematopoietic: Normal CBC
  Hepatic: Normal liver function
  Renal: Normal renal function
  Other:
  -  Normal thyroid function
  -  Normal adrenal function
  -  Normal gonadal status
  -  No myeloma or other malignancy
  -  No alcoholism, hypercortisolism or diabetes mellitus
  -  No gastrointestinal tract disease or disorder associated with malabsorption

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Thalidomide and Dacarbazine for Metastatic Melanoma

Summary: The purpose of this clinical trial is to assess the activity of thalidomide in combination with dacarbazine (DTIC) in patients with metastatic melanoma. Safety and toxicity of the two drugs will also be assessed. Dacarbazine is the standard medical treatment for metastatic melanoma. It has been shown to produce tumor shrinkage in approximately 20% of patients with advanced melanoma. This shrinkage is usually incomplete and lasts a short time. Thalidomide is a drug that inhibits tumor blood vessel growth. It can be given orally. It is hoped that this combination can be given to patients with metastatic melanoma without causing too much toxicity while increasing the response rate.


Eligibility: Inclusion Criteria:
  -  Patients with metastatic melanoma.
  -  Lesions must be measurable.
  -  Patient must have the following minimum labs: ANC> 1500/mm3, Hemoglobin > 8 mg/dl; platelets > 100,000 mm3; and liver function tests < 5x normal; and creatinine < 1.5 mg/dl.
  -  ECOG performance status > 2.
  -  No prior therapy with DTIC or thalidomide
  -  No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  -  Patients must not be pregnant or lactating.
  -  Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

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: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma

Summary: RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer.
  PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma.

Detailed description: OBJECTIVES:
  -  Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma.
  -  Correlate melastatin expression prospectively with event-free survival of these patients.
  OUTLINE: This is a multicenter study.
  Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
  Patients are followed every 4 months for 3.5 years.
  PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.

Eligibility: 1. Histologically documented primary AJCC stage I or II melanoma. Evidence of ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular invasion, microscopic satellitosis, and mitotic rate shall be noted.
  2. Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node dissection of an anatomic draining region from the index primary melanoma.
  3. ≥18 years of age
  4. Patients must be registered prior to planned surgery. The surgery must be performed within 45 days following registration.
  5. No concurrent active malignancy other than carcinoma in situ of the cervix and basal cell carcinoma of the skin, or history of any other primary malignancy including previously primary melanoma.
  6. Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow thickness. Note: If blocks cannot be sent due to institutional policy, slides may be substituted for the locks per the protocol.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

Summary: Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.
  Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.
  If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.

Detailed description: The trial is being conducted at multiple study centers throughout the United States. The trial is a double-blind, placebo-controlled trial. Participants must meet specific eligibility criteria. Study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center.
  If you qualify for and decide to participate in the trial, you will have three product administrations over the course of one month.

Eligibility: To qualify for this trial, you must have ALL of the following:
  -  Histologically documented adenocarcinoma of the prostate
  -  Cancer that has progressed while on adequate hormone therapy. This state of the disease is androgen independent prostate cancer (AIPC).
  -  Cancer that has spread outside the prostate (metastatic) to lymph nodes or bone. Please note that if your cancer has spread to organs (e.g., liver, lung, brain), you are not eligible for the study.
  -  The absence of or minimal current cancer-related pain
  Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.
  Study personnel will explain the trial in detail and answer any questions you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy

Summary: This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.


Eligibility: Inclusion Criteria:
  -  Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa).
  -  Measurable disease according to Response Criteria for Solid Tumors (RECIST).
  -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
  -  Estimated survival is greater or equal to 4 months.
  -  Negative pregnancy test (women of childbearing potential only).
  -  Pretreatment laboratory levels that meet specific criteria.
  -  Signed informed consent, including permission to use protected health information.
  Exclusion Criteria:
  -  Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies.
  -  Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens.
  -  Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
  -  Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
  -  Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M200.
  -  Documented central nervous system (CNS) tumor or CNS metastasis.
  -  History of thromboembolic events and bleeding disorders within the past year.
  -  Medical conditions that may be exacerbated by bleeding.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Safety and Efficacy Study of INGN 241 Gene Therapy in Patients With In Transit Melanoma

Summary: This is a research study to look at the ways in which a treatment called INGN241 can kill melanoma cells or help the patient's immune system kill melanoma cells.

Detailed description: INGN 241 is an adenoviral vector carrying the MDA-7 cDNA. MDA-7 is a novel tumor suppressor molecule with cytokine properties, recently designated as IL-24. Over expression of MDA-7 in melanoma cells in vitro has been shown to inhibit cellular proliferation and induce apoptosis. Loss of MDA-7 expression in human melanomas has been shown to correlate with invasion and metastasis. The INGN 241 gene transfer construct has been previously used in human subjects in an ongoing open label Phase I study using intratumoral administration, and has been well tolerated to date. The primary objectives of the present study are to determine if INGN 241, injected into a melanoma in transit lesion, can induce apoptosis in regional uninjected lesions and initiate systemic immune activation. Secondary objectives include examination of specific immunity and of clinical response and toxicity.

Eligibility: Inclusion Criteria:
  -  Histologically proven melanoma, must have 3 regional metastatic lesions that are in transit
  Exclusion Criteria:
  -  Central nervous system involvement by melanoma

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine

Summary: In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.

Detailed description: In this study, we will examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens in melanoma patients who are clinically free of disease but at high risk for recurrence. This vaccine will be compared to direct injection of the same peptides with KLH and Montanide as adjuvant.

Eligibility: Inclusion Criteria:
  -  Resected stage IIB, IIC, or stage III melanoma.
  -  Fully recovered from surgery
  -  Human leukocyte antigen (HLA) A*0201 positive.
  -  Age >18 years.
  -  Karnofsky performance status: >80% and normal labs.
  Exclusion Criteria:
  -  Prior chemotherapy.
  -  Known chronic infection with HIV, hepatitis B or C.
  -  Patients with known autoimmune disease [e.g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)]. Patients with vitiligo are not excluded.
  -  Pregnant women.
  -  Patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides).
  -  Patients who have known retinal or choroidal eye disease.
  -  Patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible.
  -  Allergy to shellfish.

Relevance to patient case: not relevant