araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Thalidomide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Summary: Phase II trial to study the effectiveness of thalidomide in treating patients with recurrent or metastatic head and neck cancer. Thalidomide may stop the growth of head and neck cancer by stopping blood flow to the tumor.

Detailed description: OBJECTIVES:
  I. Determine the effect of thalidomide on survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
  II. Determine clinical response rates following this therapy in these patients. III. Determine the toxic effects of thalidomide in these patients. IV. Determine the effect of thalidomide on tumor angiogenesis in these patients.
  OUTLINE:
  Patients receive 4-20 capsules of oral thalidomide once daily. Dose is escalated in individual patients on a weekly basis for the first 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity, or for 12 months past complete response.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven squamous cell carcinoma of the head and neck
  -  Recurrent disease OR metastatic disease at initial diagnosis or at recurrence
  -  Initial therapy of surgery and/or radiotherapy, induction chemotherapy, or concurrent chemotherapy and radiotherapy allowed
  -  No more than one prior regimen of chemotherapy or biologic therapy for metastatic disease
  -  Recurrence after adjuvant or induction chemotherapy may have received one additional course of chemotherapy or biologic therapy
  PATIENT CHARACTERISTICS:
  -  Age: 18 and over
  -  Performance status: Zubrod 0-2
  -  Life expectancy: At least 3 months
  -  WBC at least 3000/mm3
  -  Platelet count at least 100,000/mm3
  -  Hematocrit at least 30%
  -  Bilirubin no greater than 1.5 times normal
  -  SGOT/SGPT no greater than 1.5 times normal
  -  Creatinine no greater than 1.5 mg/dL
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile women must use 2 methods of effective contraception, 1 barrier and 1 hormonal, beginning at least 4 weeks before study and continuing during and for 1 month after study
  -  Men must use effective barrier contraception during and for 1 month after study
  -  No grade 2 or greater peripheral neuropathy
  -  No serious infection or other concurrent illness requiring immediate therapy
  -  Must be able to take oral medications
  -  No medical or social factors that would interfere with compliance
  PRIOR CONCURRENT THERAPY:
  -  Any number of courses of one regimen of chemotherapy allowed
  -  No concurrent cytotoxic chemotherapy
  -  No concurrent radiotherapy

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer

Summary: RATIONALE: Inserting the gene for interleukin-12 into a person's cancer cells may make the body build an immune response to kill more tumor cells.
  PURPOSE: Phase I/II trial to study the effectiveness of gene therapy in treating patients who have unresectable, recurrent, or refractory head and neck cancer.

Detailed description: OBJECTIVES: I. Determine the safety and tolerability of interleukin-12 gene in patients with unresectable, recurrent, or refractory squamous cell carcinoma of the head and neck. II. Evaluate the efficacy of this regimen in these patients.
  OUTLINE: This is a multicenter study. Patients receive interleukin-12 gene by intratumoral injection twice during week 1 and once weekly during weeks 2-7 in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: A total of 28-34 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven unresectable, recurrent, or refractory squamous cell carcinoma of the head and neck Primarily stage III or IV Tumor accessible to direct injection No tumor involving major blood vessels or obstructing airway
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 50,000/mm3 Hepatic: No prior or concurrent active liver disease SGOT and SGPT no greater than 3 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: No respiratory disease that sufficiently influences oxygenation of arterial blood Other: At least 2 weeks since prior infection No concurrent infection No active or clinically relevant viral illness No other malignancies requiring treatment during this study No prior autoimmune disease (e.g., rheumatic disease, Crohn's disease) No allergy to polyvinylpyrrolidone (PVP) or related products No prior psychiatric disability No prior seizures Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: No prior viral based gene therapy, recombinant DNA products, or bacterial plasmids Chemotherapy: At least 28 days since prior chemotherapy No concurrent chemotherapy No chemotherapy during follow up period Endocrine therapy: No concurrent corticosteroids Radiotherapy: At least 28 days since prior radiotherapy No concurrent radiotherapy No radiotherapy during follow up period Surgery: At least 28 days since prior surgery No concurrent surgery No surgery during follow up period Other: At least 30 days since prior investigational drugs No concurrent high dose nonsteroidal antiinflammatory drugs No concurrent immunosuppressive drugs

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

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: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: ZD 1839 in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck

Summary: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of head and neck cancer.
  PURPOSE: Phase II trial to study the effectiveness of ZD1839 in treating patients who have metastatic or recurrent cancer of the head and neck.

Detailed description: OBJECTIVES: I. Determine the activity of ZD 1839 in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. II. Determine the effectiveness of this regimen in these patients. III. Determine the toxicity of this regimen in these patients.
  OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.
  PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 1-2 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck that is incurable by surgery or radiotherapy At least 1 lesion measurable in at least 1 dimension At least 20 mm by conventional techniques OR At least 10 mm by CT scan No known brain metastases
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reactions to compounds of similar chemical or biological composition to ZD 1839 No active infection No other uncontrolled illness No psychiatric illness or social situation that would preclude study
  PRIOR CONCURRENT THERAPY: Biologic therapy: No prior epidermal growth factor receptor-based therapy for recurrent disease Chemotherapy: No more than 1 prior adjuvant or neoadjuvant chemotherapy and/or chemoradiotherapy regimen At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics See Chemotherapy At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: No more than 1 prior regimen for recurrent disease No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Radiation Therapy in Treating Patients With Head and Neck Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for head and neck cancer.
  PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have head and neck cancer.

Detailed description: OBJECTIVES:
  -  Compare adjuvant continuous hyperfractionated accelerated radiotherapy vs conventional radiotherapy, in terms of preventing disease recurrence, in patients with head and neck cancer.
  -  Compare the early and late toxic effects of these treatments in this patient population.
  -  Compare disease-free and overall survival of patients receiving these treatments.
  -  Assess quality of life in patients receiving these treatments.
  OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
  -  Arm I: Patients undergo radiotherapy 3 times daily, with an interval of at least 6 hours between any 2 treatments, 5 days a week, for just over 2 weeks, for a total of 13-14 treatment days.
  -  Arm II: Patients undergo radiotherapy daily, 5 days a week, for 6-6.5 weeks. Quality of life is assessed at baseline and then annually for 5 years.
  Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 460 patients (230 per arm) will be accrued for this study within 2-3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed squamous cell carcinoma of the head and neck including, but not limited to, the following:
  -  Oral cavity
  -  Oropharynx
  -  Hypopharynx
  -  Larynx
  -  Nasal sinuses
  -  Skin
  -  Undergone curative surgery within the past 70 days
  -  All macroscopic disease removed
  -  At high or intermediate risk of recurrence
  -  No low risk of recurrence
  -  No evidence of distant metastases
  -  Considered treatable by radiotherapy
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No other prior or concurrent malignancy that would preclude study participation
  -  No other uncontrolled medical illness that would preclude study participation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  See Disease Characteristics
  Surgery
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)

Summary: The purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous Cell Carcinoma of the Head & Neck and will help determine if further development is justified.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven squamous cell carcinoma of the head & neck.
  -  Age greater than or equal to 18.
  -  ECOG performance status of 0 to 1
  -  Measurable malignant disease.
  -  Patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options.
  -  Patients must be at least 2 wks post surgery or radiation therapy
  -  Patients must be at least 4 weeks post chemotherapy
  -  Meets protocol requirements for specified laboratory values.
  -  Written informed consent and cooperation of patient.
  -  Appropriate use of effective contraception if of childbearing potential.
  -  No investigational drugs of any type within 30 days prior to administration.
  Exclusion Criteria:
  -  Prior exposure to farnesyl transferase inhibitors
  -  Medical conditions that would interfere with taking oral medications.
  -  Patients with significant QTc prolongation at baseline (>500 msec.)
  -  Pregnant or nursing women
  -  Known HIV positivity or AIDS-related illness.
  -  Concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy
  -  Patients with any signs of involvement of the dura, meninges, or brain.
  -  Patients with squamous cell carcinoma of the nasopharynx
  -  Patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Acupuncture or Standard Therapy in Treating Pain and Dysfunction in Patients Who Have Undergone Neck Surgery for Head and Neck Cancer

Summary: RATIONALE: Acupuncture may help relieve pain and dysfunction caused by cancer surgery. It is not yet known whether acupuncture is more effective than standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.
  PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared to standard therapy in treating pain and dysfunction in patients who have undergone neck surgery for head and neck cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine whether acupuncture reduces pain and dysfunction in patients with head and neck cancer who have undergone neck dissection.
  Secondary
  -  Determine whether acupuncture relieves dry mouth in these patients.
  OUTLINE: This is a randomized, controlled study. Patients are stratified according to surgical procedure (selective neck dissection vs modified radical neck dissection vs radical neck dissection) and baseline Constant-Murley score (≤ 35 vs > 35). Patients are randomized into 1 of 2 treatment arms.
  -  Arm I: Patients undergo acupuncture for 20-30 minutes once weekly for 4 weeks.
  -  Arm II: Patients undergo standard of care for 4 weeks. In both arms, treatment continues in the absence of unacceptable toxicity.
  The Constant-Murley score is assessed at baseline and then at week 6. Pain medication use is recorded at baseline, during study treatment, and then at week 6. Numerical Rating Scale of pain on activity and xerostomia inventories are completed at baseline and then at weeks 5 and 6.
  After completion of study treatment, patients are followed periodically.
  PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Must have undergone neck dissection for cancer ≥ 3 months ago (in order to qualify pain as chronic sequella)
  -  Subjective complaint of pain and/or dysfunction in the neck and/or shoulders that, in the opinion of the investigator, is due to neck dissection
  -  Constant-Murley score ≤ 70 (i.e., moderate or severe pain and dysfunction)
  -  No moderate or severe neck or shoulder pain that, in the opinion of the investigator, is not due to cancer surgery
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  At least 3 months since prior radiotherapy
  -  More than 6 weeks since prior acupuncture
  -  Concurrent analgesics allowed

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)

Summary: The purpose of this trial is to determine the ability of positron emission tomography (PET) to detect residual cancer in neck lymph nodes of patients following curative treatment with radiation therapy for squamous cell cancer arising in the head and neck.
  Patients with head and neck cancer (HNC) undergo treatment of curative intent; patients who are node positive (N2 N3 stages) undergo standard management which includes post-radiation planned neck dissection but two thirds of patients end up not having evidence of residual disease in neck dissection specimens; these patients could have avoided surgery. However, currently used standard tests, like computed tomography (CT) and/or magnetic resonance imaging (MRI) cannot reliably predict who is post-radiation disease free.

Detailed description: PET-Fluorodeoxyglucose scanning is an imaging test based on the increased uptake of radiolabelled glucose by tumour cells. PET might detect neck tumours better than other imaging tests. This is a cohort study in which patients with N2 N3 squamous cell carcinoma of the head and neck undergo a PET and a CT scan at baseline and then post-radiation therapy and chemotherapy. Then, they undergo neck dissection surgery. The PET and CT results are compared with the presence or absence of tumours in the neck nodes. If PET is sufficiently accurate in predicting the presence or absence of tumours in the neck nodes, then a neck dissection could be avoided.

Eligibility: Inclusion Criteria:
  All of the following criteria must be satisfied:
  1. Histological evidence of squamous cell carcinoma of the head & neck (T1-T4 arising in either the oral cavity, larynx & pharynx, except Nasopharyngeal carcinoma);OR patients with histological evidence of squamous cell carcinoma metastatic to the neck and an unknown primary site after conventional workup without any of the following: i). Clinically suspected skin primary or previous diagnosis of skin cancer arising in the head and neck area; ii). Patients of Asian or African decent -possible nasopharynx primary; iii). Patients whose malignant adenopathy is confined to zone V -possible nasopharynx primary; and iv). Patients whose malignant adenopathy is confined to zone IV (supraclavicular)-possible lung primary.
  2. Presence of advanced N2 or N3 neck disease.
  3. Planned for primary curative radiation therapy (± chemotherapy) followed by neck dissection eight to twelve weeks after completion of treatment.
  Exclusion Criteria:
  1. Presence of distant metastasis
  2. Recurrent tumour
  3. Prior neo-adjuvant chemotherapy
  4. Previous radiation therapy to intended treatment volumes
  5. Other active malignancy
  6. Surgically inoperable neck disease
  7. Unable to remain supine for 60 minutes
  8. Unfit to undergo general anesthetic or neck dissection for medical reasons
  9. Known hypersensitivity to CT contrast
  10. Pregnancy

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC

Summary: This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell carcinoma. The main end point is the event free survival.

Detailed description: This is a multicentric randomized phase III trial comparing conventional radiotherapy with concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event free survival.
  The treatments are
  Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and D22-25 and D43-46
  Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33
  -  first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions of 2 Gy
  -  second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy in 20 fractions in 2 weeks (1,5 Gy x 2 / day)
  Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in 36 fractions of 1.8 Gy

Eligibility: Inclusion Criteria:
  -  Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx
  -  Stage III-IV (UICC 1997): T2, T3 or T4 with N0-N3 or T0 with N2-N3
  -  Not resectable
  -  Karnofsky PS >= 70
  -  Renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-FU
  -  Informed consent signed
  Exclusion Criteria:
  -  Distant metastasis
  -  Contra-indication to concomitant chemotherapy
  -  History of cancer
  -  History of head and neck radiotherapy

Relevance to patient case: not relevant