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Solid Tumors

Head and Neck

1

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:

- Non small cell lung cancer (NSCLC): locally advanced, unoperable, or metastatic disease. No more than 2 prior regimens for advanced or metastatic disease.

- Head and Neck (H & N) cancer: metastatic disease. No more than 1 prior regimen for metastatic disease.

- Esophageal cancer: metastatic disease, including (but not limited to) squamous cell carcinoma and adenocarcinoma, also including cancer at the gastroesophageal junction. No more than 1 prior regimen.

In order to be enrolled, subjects must demonstrate methylated MGMT promoter in the most recent tumor tissue sample or in the serum/plasma sample.

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.

2

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.

Control Group Patients: Eligible control patients will be matched patients aged 18 years or older and diagnosed with active cancer meeting the same criteria as above but without thrombosis

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).

Patients with cancer but without blood clots (control group) will also be enrolled in this study but will not receive study drug. For these patients, information regarding overall heath and response to their cancer treatment will be monitored. Plasma markers of hemostasis, fibrinolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months (if subject agrees)

 
Last updated: July 30, 2008
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