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Solid Tumors

Kidney/Renal Cancer

1

Disease Status and/or Stage Renal Cell Cancer
Protocol Title

ECOG 2805: A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma (RCC)
PI David Nanus, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility

Must have primary intact RCC, eligible for nephrectomy with curative intent. Tumors ≥ 4 cm and/or macroscopic fully resectable nodes and/or surgically resectable renal vein thrombus and/or surgically resectable inferior vena caval thrombus by radiologic criteria to be clinically ≥ pT1bNany (resectable) M0 disease.

No prior anti-cancer therapy is permitted in either the adjuvant or neoadjuvant setting. This includes metastectomy for renal cell carcinoma or radiation therapy to the renal bed.

Treatment Overview

Patients will be randomized to either: Arm A (sunitinib) or Arm B (sorafenib alone) or Arm C (placebo)

2

Disease Status and/or Stage Advanced, Unresectable, and/or Metastatic
Protocol Title A Phase I/II Trial of BAY 43-9006 plus Gemcitabine and Capecitabine in the Treatment of Patients with Advanced Renal Cell Carcinoma
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Must have received one prior immunotherapy based regimen.

No prior chemotherapy or prior treatment with BAY 43-9006 and/or inhibitors of the MAPK or VEGF pathways.
Treatment Overview Patients receive BAY 43-9006 days 1-21, Gemcitabine day 1 and 8, and Capecitabine days 1-14 of 21 day cycle

Patients should receive a minimum of 3 cycles of therapy. Patient may continue treatment until disease progression or unacceptable side effects.

3

Disease Status and/or Stage Metastatic or Advanced Renal Cell Cancer
Protocol Title A Phase I/II Study of Vorinostat in Combination with Isotretinoin in the Treatment of Patients with Advanced Renal Cell Carcinoma
PI David Nanus, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Must have received and failed two or more prior regimens including chemotherapy, immunotherapy, biological agents and/or radiation therapy.
Treatment Overview Vorinostat and Isotretinion given days 3-5, 10-12, 17-19 and 24-26 of 28 day treatment cycle.

Therapy length of 4 cycles (16 weeks). If patient responds eligible for additional cycles.

4

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.

5

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)

6

Disease Status and/or Stage Metastatic Solid Tumor
Protocol Title

A Phase I Study of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-591) in Patient with Nonprostate Metastic Solid Tumors: A Pilot Study

PI Scott Tagawa , MD
Contact Kristen Petrillo, R.N.
212-746-5430
 
Last updated: May 26, 2010
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