Standards message here

Solid Tumors

Melanoma

1

Disease Status and/or Stage Stage III or IV Melanoma
Protocol Title A Phase II Study of Imatinib Mesylate (STI571; NSC #716051; IND 61135) in Patients with Inoperable AJCC State III or IV Melanoma Harboring Somatic Alterations of C-KIT
PI Tsiporah Shore, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility

Patients must have histologically or cytologically confirmed inoperable stage III or IV melanoma. Patients are allowed to have had up to two prior chemotherapy regimens for metastatic melanoma (therapy with an inhibitor of the kit protein not eligible). Prior radiotherapy is allowed.

Treatment Overview

Patients will be prescribed 100 mg Imatinib mesylate tablets and instructed to take four tablets twice a day (400 mg BID) by mouth during a meal and with a large glass (8 oz.) of water. Tablets should be taken for six weeks. Patients who show any response or stable disease and no evidence of progression will be offered additional six week cycles of treatment if tolerating therapy. Patients will be followed until disease progression.

2

Disease Status and/or Stage Metastatic Bone Tumors
Protocol Title A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain in Subjects who are Not Candidates for Radiation Therapy
PI Robert Min, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility All subjects must have been treated with at least one standard therapy (systemic therapy or local irradiation therapy) for metastatic cancer to the bone and must have failed adequate pain control with such therapy.
Treatment Overview Patients will metastatic cancer to the bone who have failed adequate pain control with other standard therapy will be treated with the MRgFUS procedure and followed over a three-month post-therapy period to determine the safety and effectiveness of the ExAblate procedure for palliation of pain.

Patients will be randomized onto one of two arms.
Arm A: ExAblate procedure to the most painful target lesion.
Arm B: Placebo ExAblate treatment.

3

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: March 20, 2009
© Weill Medical College of Cornell University
Home | Privacy Notice | Disclaimer