araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

Summary: RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.
  PURPOSE: This early phase I trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that can be removed by surgery.

Detailed description: OBJECTIVES:
  Primary
  -  To evaluate the potential effects of glutamate receptor blockade on cellular pathways important in the genesis and progression of melanoma in patients with stage III or IV melanoma undergoing surgical resection.
  -  To determine whether treatment with riluzole alters expression of activated PLC and ERK in lysates from tumor tissue biopsies.
  Secondary
  -  Determine if treatment with riluzole affects the overall metabolic activity of melanoma tumors as measured by pre- and post-treatment PET scanning, pre- and post-treatment tumor mitotic rate evaluation, and pre- and post-treatment immunohistochemical staining for Ki-67.
  OUTLINE: Patients receive oral riluzole twice daily for 14 days. Within 24 hours after the final dose of riluzole, patients undergo standard surgical resection.
  Patients undergo tumor tissue sample collection at baseline and during surgery for laboratory studies. Samples are analyzed by routine histology, immunohistochemistry, western blotting, and RT-PCR for Grm1 expression, - RAS and B-raf mutations, PLC and MAP kinase activity, Ki-67 staining, and mitotic rate. Patients also undergo blood sample collection periodically for pharmacokinetics studies.
  PET scans are obtained before and after treatment to evaluate the overall metabolic activity of the tumor and how this activity changes with inhibition of the Grm1 pathway.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed melanoma
  -  Stage III or IV disease
  -  Must have at least two resectable tumors or a tumor large enough to undergo pre-treatment core needle biopsy
  -  Must be eligible for resection of disease with curative or palliative intent
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0 or 1
  -  ANC ≥ 1,000/mm³
  -  Platelet count ≥ 50,000/mm³
  -  AST/ALT ≤ 3 times upper limit of normal (ULN)
  -  Total bilirubin normal
  -  Calculated creatinine clearance ≥ 50 mL/min
  -  INR ≤ 25% of ULN
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for 48 hours after completion of study treatment
  -  No history of allergic reaction to riluzole or similar compounds
  -  No known history of hepatitis B or C
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Study of Temzolomide and Gleevec in Advanced Melanoma

Summary: This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
  -  Prior chemotherapy, immunotherapy, radiation therapy (Phase I portion only), cytokine, biologic, or vaccine therapy is permitted, however no prior treatment with temozolomide
  -  Measurable disease
  -  ECOG performance status <= 2
  -  Life expectancy greater than 3 months
  Exclusion Criteria:
  -  No prior treatment with temozolomide or imatinib mesylate
  -  Organ allografts
  -  Prior radiotherapy, or prior intratumor injection therapy, to areas of measurable disease that are used as target indicator lesions, unless progression has occurred at that site or measurable disease has developed outside the treatment area
  -  Pregnancy or lactation
  -  History of second cancer
  -  Known hypersensitivity to temozolomide or imatinib
  -  Use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Answering Questions About Vitamin D Supplementation and Sun Exposure in Patients Who Have Undergone Surgery for Stage IB, Stage II, or Stage IIIA Melanoma

Summary: RATIONALE: Gathering information about vitamin D supplementation and sun exposure in patients with melanoma may help doctors learn more about the disease and find what may affect cancer relapse.
  PURPOSE: This clinical trial is studying vitamin D supplementation and sun exposure in patients who have undergone surgery for stage IB, stage II, or stage IIIA melanoma.

Detailed description: OBJECTIVES:
  -  To examine the findings of the pilot study, that vitamin D supplementation in combination with vitamin D receptor (VDR) polymorphisms protects from late relapse (after 3 years) in patients who have had melanoma.
  -  To investigate the effects of vitamin D supplement dosage in reducing the risk of late relapse.
  -  To examine if vitamin D supplementation in combination with particular VDR polymorphisms protects from early relapse (before 3 years).
  -  To examine if serum levels of vitamin D correlate with risk of relapse in groups of patients with different VDR polymorphisms.
  -  To examine the effect of vitamin supplementation and VDR status on time to relapse and survival in these patients.
  -  To examine other factors that may affect risk of relapse by assembling a tissue (genomic DNA and serum) resource.
  -  To investigate the effect of exposure to incidental drugs, such as statins, on risk of relapse in these patients.
  OUTLINE: Patients are stratified according to disease relapse in the past 5 years (yes vs no).
  Patients are asked to complete a food frequency questionnaire focusing on vitamin D and the following area: supplementation of diet with vitamins/fish oil and duration of use; sun exposure and sunscreen-use per decade prior to and after diagnosis. Patients are also asked to provide a blood sample for serum and DNA analysis. Consenting patients are also tagged with the Office of National Statistics to allow passive follow up.
  Stored tissue from the patient's primary melanoma may be used to corroborate research findings using immunohistochemistry or studies of gene expression, polymorphism, or mutation.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosed with melanoma
  -  Must meet either of the following conditions:
  -  Resected stage IB, II, or IIIA disease that has relapsed as either stage III or IV disease (cases)
  -  First loco regional and/or visceral relapse (with/without sentinel node biopsy)
  -  No more than 3 months since first relapse
  -  Resected stage IB, II, or IIIA disease that has not relapsed for ≥ 5 years (controls)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma

Summary: Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.

Detailed description: GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed metastatic melanoma
  -  Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed
  -  Normal organ and marrow function
  -  Willing to submit to blood sampling for planned PK/PD analyses
  -  Ability of understand and willingness to sign a written informed consent
  Exclusion Criteria:
  -  No other investigational or commercial agents or therapies
  -  Prior exposure to GMX1777, GMX1778 or CHS828
  -  Patients with uncontrolled, intercurrent illness
  -  Pregnant or breastfeeding women

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma

Summary: The purpose of this study is to examine the experiences and quality of life of women who have been treated for melanoma. By quality of life, we mean how they are feeling about different aspects of their life. In this study, we are especially interested in their feelings about survival, physical appearance and any family concerns. We will administer a series of QOL questionnaires, data sheets with many questions, to get their response to measure their feelings about these issues.


Eligibility: Inclusion Criteria:
  -  Age 18 years or older
  -  Clinically node-negative primary cutaneous melanoma.
  -  Patients participating must be female
  -  Patients must have completed surgical treatment for melanoma at least 10 days ago and less than 2 years at the time of study entry.
  Exclusion Criteria:
  -  Prior history of cancer with the exception of squamous or basal cell carcinoma of the skin.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

Summary: The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to GM-CSF.


Eligibility: Inclusion Criteria:
  -  Males or females age ≥ 18 years
  -  Stage IIIb, IIIc or stage IV disease that is not surgically resectable
  -  Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance)
  -  At least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion >= 10 mm in longest diameter or, multiple injectable melanoma lesions which in aggregate have a longest diameter of >= 10 mm
  -  Serum lactate dehydrogenase (LDH) levels less than 1.5 x upper limit of normal (ULN)
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Prolongation in International Normalized Ratio (INR), Prothrombin Time (PT), and Partial Thromboplastin Time (PTT) when the result is from therapeutic anticoagulation treatment are permitted for patients whose injectable lesions are cutaneous and/or subcutaneous such that direct pressure could be applied in the event of excessive bleeding
  Exclusion Criteria:
  -  Clinically active cerebral or any bone metastases. Patients with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (2) months prior to randomization
  -  Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For patients with < 3 visceral metastases, no lesion > 3 cm, and liver lesions must meet Response Evaluation Criteria In Solid Tumors (RECIST) criteria for stable disease for at least 1 month prior to randomization

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Feasibility and Functionality of fPAM Imaging in Melanoma

Summary: Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional (lymph node) recurrence. These recurrences may be difficult to detect in their earliest stages. We are attempting to use novel form of skin imaging that uses ultrasound combined with laser to identify these recurrences early, when they may be most amenable to treatment. This imaging will detect melanoma pigment below the surface of the skin and in the draining lymph nodes, as well as new blood vessel formation that occurs with these loco-regional metastases.

Detailed description: recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions

Eligibility: Inclusion Criteria:
  -  Adult patients (> 18 yrs of age) with recently diagnosed or a history of, Stage I - III melanoma who are able to give informed consent.
  Exclusion Criteria:
  -  Patients with melanomas < 1mm.
  -  Pregnant females.
  -  Children and young adults < 18 yrs of age and patients who are unable to give informed consent.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Tailored Intervention for Melanoma Patient's Families

Summary: The purpose of the investigators' study is to find the best way to provide information about sun protection and skin cancer detection. The investigators want to see which of two methods most improves sun protection and screening attitudes and practices. The investigators hope to improve these attitudes and practices among people who are at higher risk for melanoma. People at higher risk for melanoma are first degree relatives (mother, father, sibling or child) of people diagnosed with melanoma.

Detailed description: Eligible patients will be contacted to find out whether they have any living first degree relatives that we may contact to discuss their participation in our study.
  Eligible first degree relatives (FDRs) will participate in our study as outlined under Interventions.

Eligibility: Inclusion Criteria - Patients (for referral of FDRs):
  -  Newly diagnosed with cutaneous malignant melanoma (CMM) within the past 2 years but more than 3 months prior to being approached
  -  Seen at FCCC, FCCC Network, Temple, MCC, or HUP patient clinics
  -  Greater than 18 years of age
  -  English speaking
  -  Able to give meaningful informed consent
  -  Does NOT have a first-degree relative with CMM
  Inclusion Criteria - FDR (First Degree Relative):
  -  Current age of at least 21 years
  -  One or more of the following additional risk factors; blonde or red hair; marked freckling on the upper back; history of 3 or more blistering sunburns prior to age 20; 3 or more years of an outdoor summer job as a teenager; Actinic keratosis
  -  Able to give informed consent
  -  English speaking
  -  Has residential phone service
  -  No personal history of CMM or non-melanoma skin cancer
  -  No personal history of dysplastic nevi
  Exclusion Criteria - FDR:
  -  2 or more first degree relatives with CMM
  -  Has had a total cutaneous examination (TCE) in the past 3 years AND has done skin self-examination (SSE) more than once in the past year AND has a sun protection habits mean score greater than or equal to 4 (often). We are selecting a set participants who are NOT compliant with TCE and are inconsistent/minimal performers of SSE and sun protection practices.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Comparison of Video-Based Versus Written Patient Education on Melanoma

Summary: The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' understanding of melanoma.

Detailed description: We plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' understanding of melanoma.
  Subjects randomized to the video-based education arm will be instructed to watch a video on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. Subjects randomized to the written education arm will receive written information on the definition of melanoma, risk factors associated with the development of melanoma, and signs that should prompt an evaluation for melanoma. The contents of the video and the written educational materials will be comparable.
  At the end of the study period 1 month later, subjects will be interviewed via telephone regarding their understanding of melanoma. Subjects will also be interviewed regarding their comprehension and attitude towards video-based and written education materials.

Eligibility: Inclusion Criteria:
  -  18 years of age or older at time of consent, may be men or women.
  -  Able to adhere to the study visit schedule and other protocol requirements.
  -  Capable of giving informed consent.
  Exclusion Criteria:
  -  Non-English speaking individuals.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Effect of Biological Therapy on Biomarkers in Patients With Untreated Hepatitis C, Metastatic Melanoma, or Crohn Disease

Summary: RATIONALE: Studying samples of blood from patients with cancer, hepatitis C, or Crohn disease in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer and other diseases.
  PURPOSE: This laboratory study is looking at the effect of biological therapy on biomarkers in patients with untreated hepatitis C, metastatic melanoma, or Crohn disease.

Detailed description: OBJECTIVES:
  -  To determine how a variety of immune-modulating therapies (i.e., interferon alfa [IFN-α] in patients with untreated acute or chronic hepatitis C, anti-tumor necrosis factor in patients with active inflammatory bowel disease (i.e., Crohn disease), and anticytotoxic T-lymphocyte antigen immunoglobulin in patients with metastatic melanoma) affect the tissue expression of indoleamine 2, 3 dioxygenase (IDO), a major immune-regulatory mechanism.
  -  To determine whether administration of pegylated INF-α in patients with untreated acute and chronic hepatitis C causes systemic changes in the IDO pathway, as indicated by lowered serum tryptophan (TRP) and elevated serum kynurenine (KYN).
  -  To determine whether administration of ticilimumab (i.e., anti-CTLA4 human monoclonal antibody CP-675,206) in patients with metastatic melanoma inhibits activation of the IDO pathway as indicated by normal serum TRP and normal serum KYN.
  -  To determine whether administration of infliximab in patients with Crohn disease inhibits activation of the IDO pathway, as indicated by normal serum TRP and normal serum KYN.
  OUTLINE: Serum samples are collected from patients with hepatitis C and metastatic melanoma at baseline and at 3 to 4 weeks after treatment is initiated. Previously collected samples from patients with Crohn disease are also assessed at these time points. Samples are analyzed for tryptophan and kynurenine levels via high-performance liquid chromatography.
  PROJECTED ACCRUAL: A total of 15 patients with untreated acute or chronic Hepatitis C, 15 patients with metastatic melanoma, and 20 patients with Crohn disease will be accrued for this study.

Eligibility: Inclusion Criteria:
  DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following:
  -  Acute or chronic hepatitis C
  -  Receiving pegylated interferon alfa and ribavirin
  -  Metastatic melanoma
  -  Receiving ticilimumab
  -  Crohn disease
  -  Received prior infliximab
  Exclusion Criteria:
  -  Not specified
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.
  PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.

Detailed description: OBJECTIVES:
  -  Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy.
  -  Develop a survival model for relapse based on sentinel lymph node biopsy positivity.
  -  Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma.
  OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs > 4 mm) and gender.
  Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A).
  Patient data related to relapse and recurrence is collected, if available.
  Peer reviewed and funded or endorsed by Cancer Research UK
  PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Confirmed diagnosis of cutaneous melanoma
  -  Breslow thickness > 0.75 mm
  -  Has undergone sentinel lymph node biopsy
  -  No primary melanoma that has not originated in the skin
  -  No multiple primary melanomas
  -  Currently under clinical followup OR discharged from follow up within the past 3 months
  PATIENT CHARACTERISTICS:
  -  No other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant