Articles

  • A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy

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    A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy


    Condition: Penile Squamous Cell Carcinoma (PSCC)

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02541903

    Sponsor: University of Alabama at Birmingham

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • 1. Histologically or cytologically confirmed PSCC. 2. Patients with metastatic or locally advanced unresectable PSCC. 3. Progressive disease after ≥1 prior chemotherapy regimens. 4. Measurable disease by RECIST 1.1 criteria. 5. Prior regimen within 6 months 6. ECOG performance status 0-2. 7. Adequate organ function, defined as all of the following:
    • Absolute neutrophil count (ANC) >1500 /mm3. Platelet count >100,000/ mm3.
    • Estimated creatinine clearance ≥ 45ml/min.
    • Total Bilirubin <1.5 times upper limit of institutional normal; Aspartate amino transferase (AST) or alanine amino transferase (ALT) <2.5 times the upper limit of institutional normal (ULN).
    • Hemoglobin ≥8.5 g/dl. 8. Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to NCI CTCAE version 4.03 grade <1, in the opinion of the Treating Physician. 9. Ability to understand and willingness to sign a written informed consent. Age ≥18 years or age of majority at the participating site, whichever is greater. 10. Availability of 20 archival formalin-fixed paraffin embedded tumor tissue slides.

    Exclusion Criteria:

    1. Patients will have recovered from toxicities from prior systemic anticancer treatment or local therapies.
    2. Prior EGFR inhibitors.
    3. Major surgery within 4 weeks or minor surgery within 2 weeks before registration or scheduled for surgery during the projected course of the study. Wounds will be completely healed prior to study entry and patients recovered from all toxicities from surgery. Placement of vascular access device is not considered major or minor surgery in this regard.
    4. Prior radiation therapy is allowed as long as the irradiated area was not the sole source of measurable disease and radiotherapy was completed with recovery from toxicity, at least 3 weeks prior to enrollment. If the irradiated area is the only site of disease, there will be progressive disease.
    5. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to registration.
    6. Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug.
    7. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
    8. Requiring treatment with any of the prohibited concomitant medications listed in the protocol that cannot be stopped for the duration of trial participation.
    9. Known pre-existing interstitial lung disease.
    10. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption).
    11. Active hepatitis B infection (defined as presence of Hep BsAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
    12. Meningeal carcinomatosis.
    13. Patients with active brain or subdural metastases are not eligible, unless they have completed local (radiation) therapy and have discontinued the use of corticosteroids or have been on stable dose of corticosteroids for at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases will be stable for at least 4 weeks before starting study treatment.
    14. Any active or uncontrolled infection.

    View trial on ClinicalTrials.gov


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    Published August 6, 2019
  • International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

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    International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)


    Condition: Squamous Cell Carcinoma of the Penis, Usual Type

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02305654

    Sponsor: Institute of Cancer Research, United Kingdom

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • 1. Written informed consent 2. Measurable disease as determined by RECIST (version 1.1) criteria; 3. Histologically-proven squamous cell carcinoma of the penis, 4. Stage:
    • any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
    • any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or;
    • any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0 5. Performance Status ECOG 0, 1 or 2.

    Exclusion Criteria:

    1. Pure verrucous carcinoma of the penis,
    2. Nonsquamous malignancy of the penis,
    3. Squamous carcinoma of the urethra,
    4. Stage M1,
    5. Previous chemotherapy or chemoradiotherapy,
    6. Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years.

    View trial on ClinicalTrials.gov


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    Published July 18, 2019
  • Phase II Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma Following Previous Chemotherapy

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    Phase II Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma Following Previous Chemotherapy


    Condition: Penile Squamous Cell Carcinoma

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02837042

    Sponsor: University of Alabama at Birmingham

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • 1. Locally advanced unresectable or metastatic stage 4 (i.e. T4 or N3 or M1) PSCC 2. Radiologic evidence for progressive disease after ≥1 prior chemotherapy regimen 3. Be at least 18 years of age on day of signing informed consent. 4. Have measurable disease based on RECIST 1.1. 5. Have a performance status of 0-2 on the ECOG (Eastern Cooperative Oncology Group) Performance Scale. 6. Demonstrate adequate organ function with all screening labs being performed within 14 days of treatment initiation.
    • Absolute neutrophil count (ANC) ≥1,500 /mcL
    • Platelets ≥100,000/mcL
    • Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin dependency (within 7 days of assessment)
    • Serum creatinine ≤1.5 X upper limit of normal (ULN); alternately measured or calculated creatinine clearance ≥30 mL/min with creatinine levels >1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl)
    • Serum total bilirubin ≤1.5 X ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels >1.5 ULN
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN or ≤ 5 X ULN for subjects with liver metastases
    • Albumin >2.5 mg/dL
    • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 7. Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy 8. Formalin-fixed paraffin embedded (FFPE) tumor tissue from previous biopsy is requested, but not mandatory. 9. Be willing and able to provide written informed consent/assent for the trial.

    Exclusion Criteria:

    • 1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 3. Has a known history of active TB (Bacillus Tuberculosis) 4. Hypersensitivity to Pembrolizumab or any of its excipients. 5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
    • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. 9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 10. Has known history of, or any evidence of active, non-infectious pneumonitis. 11. Has an active infection requiring systemic therapy. 12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 14. Is pregnant expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). 18. Has known active Tuberculosis infection. 19. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

    View trial on ClinicalTrials.gov


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    Published August 14, 2019
  • The Danish National Penile Cancer Quality database.

    The Danish National Penile Cancer Quality database (DaPeCa-data) aims to improve the quality of cancer care and monitor the diagnosis, staging, and treatment of all incident penile cancer cases in Denmark.

    Published January 4, 2017