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| Disease Status and/or Stage | Locally Advanced or Metastatic Lung, Head, Neck, or Esophageal Cancer |
|---|---|
| Protocol Title | A Phase 2 Study of Temozolomide (SCH 52365) in Subjects with Advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltransferase (MGMT) Promoter |
| PI | Allyson Ocean, MD |
| Contact | Kristen Petrillo, RN 212-746-5430 |
| Key Eligibility | Eligibile subjects must have one of the following: |
| Treatment Overview | Subjects will first be screened for the presence of a specific gene profile (methylated MGMT promoter and MMR status) through tumor tissue samples and in blood samples. Eligible subjects will then receive temozolomide 150 mg/m2 daily on Days 1-7, and 15-21 (total of 14 days) for each 28-day cycle. Study treatment cycles will be repeated every 28 days until disease progression or intolerable toxicity. Tumor assessments will be performed every 8 weeks of all known tumor sites. Subjets will have study evaluation visits on Day 1 of each treatment cycle, at End of Study. Treatment/discontinuation subjects will also be followed up every 8 weeks by clinic visits or phone. |
| Disease Status and/or Stage | Any Stage of Cancer |
|---|---|
| Protocol Title | Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism (VTE) in Patients with Cancer |
| PI | Scott Tagawa, MD |
| Contact | Kristen Petrillo, RN 212-746-5430 |
| Key Eligibility | VTE Treatment Group: Eligible subjects must be age 18 years or older, diagnosed with active cancer and have a documented first venous thromboembolic event. Subjects must be currently receiving any treatment for cancer. In addition, subjects must have a documented first venous thromboembolic event (VTE). Subjects must not be in need of long-term anticoagulant therapy or be undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia or has other conditions associated with persistent thrombocytopenia of less than 100x109/L for a duration of at least four consecutive weeks. |
| Treatment Overview | All eligible subjects with VTE will receive tinzaparin 175 U/kg/day for at least 6 months with another 6 months at the investigator's discretion (up to one year study treatment). Plasma markers of hemostasis, fibrolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months after start of tinzaparin treatment (if subject agrees). |