Phase II

ACE-041

Description:

This is a Phase II study of ACE-041 for patients with recurrent or metastatic squamous cell carcinoma of the head and neck. ACE-041 is a recombinant protein that is administered once every three weeks by SC injection and targets ALK1.


Type(s) of Cancer: Head and Neck
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

AVL-292

Description:

AVL-292 is a selective, orally administered, inhibitor of Bruton’s tyrosine kinase (Btk). The expression of Btk is found on B-lymphocytes and has been implicated in the growth and survival of certain B-cell lymphomas as well as in CLL. This is a Phase Ib, escalating dose study of AVL-292 as a monotherapy in subjects with relapsed and/or refractory B-cell non-hodgkin lymphoma, chronic lymphocytic leukemia, and Waldenstrom’s macroglobulinemia


Type(s) of Cancer: Leukemia/Blood/Hematologic
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

AVL-292

Description:

AVL-292 is a selective, orally administered, inhibitor of Bruton’s tyrosine kinase (Btk). The expression of Btk is found on B-lymphocytes and has been implicated in the growth and survival of certain B-cell lymphomas as well as in CLL. This is a Phase Ib, escalating dose study of AVL-292 as a monotherapy in subjects with relapsed and/or refractory B-cell non-hodgkin lymphoma, chronic lymphocytic leukemia, and Waldenstrom’s macroglobulinemia


Type(s) of Cancer: Lymphoma
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

BNC105P

Description: BNC105P is a vascular disrupting agent that inhibits tubulin polymerization, causing cell cycle arrest and disruption of the tumor vasculature. It is administered intravenously on days 1 and 8 of a 21 day cycle in combination with Everolimus in patients with metastatic clear cell renal carcinoma after progressing on prior tyrosine kinase inhibitors.
Type(s) of Cancer: Kidney
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

Cetuximab+Docetaxel+Cisplatin+Bevacizumab+XRT

Description:

This Phase II study of cetuximab in combination with docetaxel, cisplatin, bevacizumab and radiation in patients with locally advanced head and neck cancer. Cetuximab binds to epidermal growth factor receptor and blocks the activity of epidermal growth factor.


Type(s) of Cancer: Head and Neck
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

CFG920

Description:

CFG920 is a non-steroidal, reversible dual inhibitor of CYP17 and CYP11B2 with potential antiandrogen and antineoplastic activities. In this Phase I/II study CFG920 will be administered orally in patients with metastatic castration-resistant prostate cancer after progressing (or have refused) on Abiraterone and Docetaxel.


Type(s) of Cancer: Prostate Cancer
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

G 202

Description:

G-202 is a pro-drug, consisting of cytotoxic analog of thapsigargin and a peptide to activate it at the tumor site. It is administered by intravenous infusion daily for 3 consecutive days on a 28 day cycle in patients with advanced hepatocellular carcinoma after progression on Sorafenib therapy.


Type(s) of Cancer: Liver
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

GA101

Description:

GA101 is a humanized third generation monoclonal antibody that binds to CD20, expressed in cancerous B cells. In preclinical studies it shows greater antibody-dependent cellular cytotoxicity than other CD20 antibodies and can so be potentially more effective. In this Phase II study GA101 is administered in combination with CHOP chemotherapy in patients with previously untreated advanced diffuse large B-cell lymphomas.


Type(s) of Cancer: Lymphoma
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

IMC-A12

Description:

IMC-A12 is a recombinant human antibody that binds to VEGFR-2 blocking the action of VEGF ligand. This approach inhibits the growth of blood vessels that provide the tumor with nutrients and energy. This Phase II study combines IMC-A12 with Paclitaxel and Carboplatin in patients with advanced non-squamous, non-small cell lung cancer.


Type(s) of Cancer: Lung
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

INNO-206

Description:

INNO-206 is an albumin-binding prodrug of Doxorubicin developed to improve the therapeutic effects of Doxorubicin and to decrease the toxicities. In this randomized Phase II study patients with metastatic, locally advanced, or unresectable soft tissue sarcoma will receive INNO-206 or Docorubicin intravenously once every 3 weeks.


Type(s) of Cancer: Sarcoma
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

M402

Description:

M402 is a heparin sulfate mimetic designed to have antitumor effect without the anticoagulant activity. In this Phase I/II study M402 is administered as daily subcutaneous injection with Gemcitabine in patients with metastatic pancreatic cancer who have not received prior chemotherapy.


Type(s) of Cancer: Pancreas
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

Metformin

Description:

Metformin is widely used anti-diabetic medicine. It can also act as an anti-cancer agent by activation of AMP-activated protein kinase (AMPK) pathway and subsequent inhibition of mTOR that blocks the cancer cell growth and proliferation. It may also lessen the symptoms of metabolic syndrome caused by androgen deprivation therapy. In this Phase II study patients with advanced prostate cancer will be randomly selected to receive castration only or castration plus metformin as first line treatment.


Type(s) of Cancer: Prostate Cancer
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

MLN4924

Description:

MLN4924, Nedd8-activating enzyme inhibitor, is administered intravenously on days 1, 3 and 5 of a 21 day cycle in patients with AML and high-grade myelodysplastic syndrome.


Type(s) of Cancer: Leukemia/Blood/Hematologic
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

MLN8237

Description:

MLN8237 is an oral selective small molecule inhibitor for Aurora A kinase. Aurora A kinase has a regulatory roll in cell mitosis and is over-expressed in many tumors. In the Phase I part of the study MLN8237 is taken twice a day for 7 days every 21 days with Rituximab and in the Phase II part of the study with Rituximab and Vincristine by patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are CD 20 positive.


Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

MLN8237+ Docetaxel

Description: MLN8237 is an orally administered small molecule inhibitor of Aurora A kinase. Aurora kinases are involved in cell division and inhibiting them may result in the inhibition of cell proliferation. In this Phase II study MLN8237 is given together with Docetaxel and Prednisone in chemo-naïve patients with castration-resistant prostate cancer.
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

Nexrutine in Prostrate Cancer Patients Undergoing Surgery or Radiation Therapy (only open to veterans)

Description:

For veterans only; Patients will take Nexrutine® (an oral dietary supplement) prior to and during radiation treatment for prostate cancer or prior to surgery for prostate cancer. The purpose of the study is to see whether taking Nexrutine® will cause the PSA (Prostate Specific Antigen) to decline.


Type(s) of Cancer: Prostate Cancer
Study Phase(s): Phase II
Contact: Carol Jenkins at (210) 450-5924

Reolysin+Paclitaxel+Carboplatin

Description: This is a Phase II study where Reolysin is administered intravenously days 1-5 with Paclitaxel and Carboplatin to patients with stage IIIB or IV squamous cell carcinoma of the lung as a first line treatment.
Type(s) of Cancer: Lung
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

Reolysin+Paclitaxel+Carboplatin

Description: In this Phase II study Reolysin will be administered intravenously 5 consecutive days in combination with Paclitaxel and Carboplatin in patients with metastatic melanoma.
Type(s) of Cancer: Melanoma
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

RTOG 0913

Description:

Description: This is a Phase I/II study of RAD001 (everolimus) for patients with glioblastoma or gliosarcoma (brain tumor). Patients are randomized to receive RAD 001 with the standard treatment of radiation plus temozolomide (oral chemotherapy) or to receive the standard treatment of radiation plus temozolomide alone.


Type(s) of Cancer: Brain
Study Phase(s): Phase II
Contact: Carol Jenkins at (210) 450-5924

S1108/MLN8237

Description:

MLN8237 is an oral selective small molecule inhibitor for Aurora A kinase. Aurora A kinase has a regulatory roll in cell mitosis and is over-expressed in many tumors. In this Phase II study MLN8237 is taken twice a day on days 1-7 every three weeks by patients with relapsed or refractory peripheral T-cell Non-Hodgkin lymphoma.


Type(s) of Cancer: Lymphoma
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

SAHA+Hydroxychloroquine

Description:

SAHA is a HDAC inhibitor. SAHA may also block angiogenic signaling by inhibiting the VEGF receptors expression and also reduce circulating levels of inflammatory cytokines. In this study SAHA is administered with Hydroxychloroquine in patients with advanced solid tumors


Type(s) of Cancer: Colon Cancer
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

SAHA+Hydroxychloroquine

Description:

SAHA is a HDAC inhibitor. SAHA may also block angiogenic signaling by inhibiting the VEGF receptors expression and also reduce circulating levels of inflammatory cytokines. In this study SAHA is administered with Hydroxychloroquine in patients with advanced solid tumors


Type(s) of Cancer: Kidney
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

TH-302

Description:

TH-302 is a drug that is inert unless activated by enzymes present under low oxygen condition. As many cancer types have low oxygen supply due to the rapid consumption by tumor cells, TH-302 is then broken down in these tumors to its active form which then can kill cancer cells. TH-302 will be administrated on days 1 and 15 with Bevacizumab in patients with recurrent high grade astrocytoma following progression with combined treatment with radiation and temozolomide and also after anti-angiogenic treatment.


Type(s) of Cancer: Brain
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

Tivozanib

Description:

Tivozanib is an oral VEGF receptor tyrosine kinase inhibitor. Patients with renal cell carcinoma who have received no prior systemic therapy for mRCC will be randomized to receive Tivozanib or Sunitinib for 12 weeks after what they will cross over for the other study drug they did not receive during the first 12 weeks.


Type(s) of Cancer: Kidney
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798

VB-111

Description: VB-111 is a gene therapy against tumor blood vessels. It consists of a modified cold virus (Adenovirus) which delivers an endothelial angiogenic-specific promoter and a pro-apoptotic Fas Chimera transgene. It targets the growing blood vessels within the tumor to cause their destruction. VB-111 is administered as a single intravenous infusion in patients with glioblastoma multiforme who have disease progression or recurrence following standard of care treatment with Temozolomide and radiation.
Type(s) of Cancer: Brain
Study Phase(s): Phase II
Contact: Epp Goodwin at (210) 450-5798