Solid Tumors
Kidney/Renal Cancer
1
| Disease Status and/or Stage | Metastatic Renal Cell Cancer |
|---|---|
| Protocol Title | Axitinib(AG-013736) as second line therapy for metastatic renal cell cancer: AXIS Trial |
| PI | David Nanus , MD |
| Contact | Kristen Petrillo, RN 212-746-5430 |
| Key Eligibility | Patients must have histologically confirmed clear cell renal cancer, measurable disease, and
must have failed first-line regimen containing one or more of the following agents: sunitinib, bevacizumab + IFN α, temsirolimus, or cytokine(s). |
| Treatment Overview | This is a 2-arm, randomized, Phase 3 study of AG-013736 vs sorafenib. Arm A: Axitinib 5/7/10 mg PO BID. Dose All patients will be followed for survival every 3 months for at least 3 years after randomization of last patient. |
2
| Disease Status and/or Stage | Metastatic or Advanced Renal Cell Cancer |
|---|---|
| Protocol Title | A Global, Multicenter, Open-Label, Single Agent, Two-Stage, Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects with Advanced Renal Cell Carcinoma |
| PI | Scott Tagawa, MD |
| Contact | Kristen Petrillo, RN 212-746-5430 |
| Key Eligibility | Subjects must have histologically confirmed advanced or metastatic renal cell carcinoma with the primary tumor in place or following nephrectomy. Subjects must have measurable disease and have had 1-3 prior systemic treatments for advanced or metastatic disease. |
| Treatment Overview |
Eligible subjects will receive open-label AMG 102 at 20 mg/kg by IV infusion once every 2 weeks. Subjects may receive study treatment for up to 12 months or until radiologically and/or clinically confirmed progression or unacceptable toxicity. AMG 102 pharmacokinetics analysis will be perfomed as well as analysis of anti-AMG 102 antibodies while receiving study treatment, at the end of treatment visit, the safety follow-up visit, and the end of study visit. There are 2 exploratory studies, which requires the subject to authorize release of slides from their archived tumor tissue and blood draws. |
3
| Disease Status and/or Stage | Renal Cell Cancer |
|---|---|
| Protocol Title | ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma 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) |
4
| 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 | David Nanus, 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. |
5
| 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. |
6
| Disease Status and/or Stage | Metastatic or Locally Advanced Renal Cell Cancer |
|---|---|
| Protocol Title | Study VEG108844, a Study of Pazopanib versus Sunitinib in the Treatment of Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma |
| PI | David Nanus, MD |
| Contact | Kristen Petrillo, RN 212-746-5430 |
| Key Eligibility | Patients must have a diagnosis of renal cell carcinoma with clear-cell component histology and received no prior systemic therapy (interleukin-2, interferon-α, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic renal cell carcinoma. |
| Treatment Overview | Patients will be randomized to receive either pazopanib 800mg daily dosing continuously or sunitinib 50mg once daily in 6-week cycles of dosing for 4 weeks of treatment followed by 2 weeks without treatment. |
7
| 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. |
8
| 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). |
Last updated: July 8, 2009 |
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