Clearview Cancer Center

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Clinical Trials

Did you know Clearview Cancer Institute has been involved in Clinical Research for over 18 years? Findings from clinical trial research have led to significant advances in cancer prevention and treatment, and Clearview offers numerous clinical trials whereby patients who volunteer for them receive innovative, state-of-the-art cancer care.

Early Phase

A Phase 1b, escalating dose study of AVL-292 , a Bruton’s Tyrosine Kinase (Btk )Inhibitor, as monotherapy in subjects with relapsed and/or refractory B cell NHL, CLL and Waldenstrom’s Macroglobulimemia

Rationale:

Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia are classified as B cell malignancies. Bruton’s tyrosine kinase (Btk) is found mostly in B-lymphocytes, monocytes and mast cells or basophils and is a B-cell receptor (BCR) which is important in cell development. Some B-cell malignancies depend on BCR signaling for survival. Interruption of this signaling may cause cell death. AVL-292 is a select, potent oral compound that inhibits Btk activity resulting in cell death.

Purpose:

Evaluate the safety, tolerability and dose limiting toxicities of AVL-292 when administered orally once daily to patient’s with relapsed or refractory B cell non Hodgkin Lymphoma, chronic lymphocytic leukemia or Waldenstrom’s macroglobulinemia (WM). The trial will also find the recommended dosing of AVL-292 for future studies with this compound.

Eligibility:

• Must have confirmed B-NHL , CLL or WM. • ECOG performance status of > 2. • Must have had at least one treatment regimen. Patients with DLBCL must have failed, refused, be ineligible or not otherwise appropriate, per their physician, for autologous stem cell transplant. • Adequate cardiac function by MUGA or ECHO. • Must have recovered from toxicities from prior treatments. • Adequate labs. • Patient who have received an allogenic bone marrow transplant are not eligible. • Active central nervous system involvement by lymphoma is exclusionary. • Patients with certain blood conditions are not eligible. • Use of corticosteroids greater than 20mg/d is exclusionary. • Cannot have active infection. • Certain heart conditions are exclusionary. • History of another active cancer less than 2 years prior to study dosing is exclusionary. • Cannot have had a major surgical procedure within 28 days of study drug administration. • Certain eye conditions are exclusionary. • Patients that are Hepatitis B or Hepatitis C or HIV positive are excluded.

Treatment:

AVL-292 125 mg by mouth daily. This dose will escalate with each cohort.

Contact:

Kathy Cutter, RN, BSN; 256-705-4248




A Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with Paclitaxel plus Carboplatin in Chemotherapy-naive Patients with Stage IV Non-Small-Cell Lung Carcinoma (NSCLC)

Rationale:

Non-small-cell lung carcinoma (NSCLC) is a leading cause of cancer death world wide. The current standard of care for front-line treatment of patients with advanced NSCLC consist of systemic chemotherapy that is chosen based in part of the type of cancer cell and other symptoms that you are experiencing. Belinostat (the study drug) is an inhibitor of an enzyme (HDAC - important to tumor growth) and increases the anti-tumor activity of the standard of care drugs: Paclitaxel and Carboplatin.

Purpose:

To determine the maximum tolerated dose (MTD) of Belinostat in combination with Carboplatin and Paclitaxel in patients with stage IV NSCLC who have received no prior systemic chemotherapy

Eligibility:

Diagnosis of Stage IV NSCLC.

No systemic chemotherapy for advanced NSCLC. Prior adjuvant treatment for early stage lung cancer is allowed, provided it has been at least 12 months.

Patients must have adequate lab values to participate.

Patients that have HIV, Hep B or C are excluded.

Patients on certain medications or with Long QT syndrome are excluded.

Treatment:

Patients will receive Belinostat on days 1-5, and on day three (3) will receive Paclitaxel and Carboplatin every 21 days for six (6) cycles

Contact:

Leslie Smoot, RN; 256-705-4246




A Phase I Study to Investigate the Safety and Clinical Activity of CAL-101 in Combination with Bendamustine and Rituxan in Patients with Relapsed or Refractory Indolent B-cell Non Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia

Rationale:

CAL-101 is a small molecule that inhibits a protein P13K that is expressed in Non Hodgkin’s Lymphoma and Leukemia. Through a series of signaling pathways, CAL-101 inhibits the production of this protein (P13K) which effects cell survival, proliferation, growth and metabolism.

Purpose:

This Phase I study will be the first time that CAL-101 is administered in combination with chemotherapy in patients with relapsed or refractory indolent B-cell Non Hodgkin’s Lymphoma or CLL. This study will establish initial safety and clinical activity of CAL-101 in combination with Rituximab and Bendamustine

Eligibility:

• Documented histologically or cytologically confirmed select types of B-cell indolent NHL or CLL • Previously treated with relapsed or refractory disease (refractory defined as not responding to a standard treatment or progressing within 6 months of the last course of standard treatment.) • Must have measurable disease • Patient’s with atypical immunophenotype with t(11:14) translocation or cyclin D1 over-expression are excluded • Patient’s that have been treated within 4 weeks are excluded • Patient’s that have had an allogeneic hematopoietic stem cell transplant are ineligible • Patient’s with central nervous system involvement are excluded • Must have adequate lab values • Patient’s who test positive for HIV, hepatitis B or C are excluded • Patient’s on certain medications are excluded

Treatment:

Patients will be enrolled in one of the three arms of the study. Arm 1 – CAL-101 and Bendamustine Arm 2 – CAL- 101 and Rituximab Arm 3 – CAL-101, Bendamustine and Rituximab

Contact:

Kathy Cutter, RN, BSN phone: 256-705-4248




Current Clinical Trials:

[Emily Pauli, Pharm.D.]Emily Pauli, Pharm.D.Director of Research

If you are interested in more information on clinical trials at Clearview, please feel free to contact us (256) 705-4224. More information regarding clinical trials can be found at: www.ClinicalTrials.gov

Entering a Clinical Trial: Is it right for you? Download the PDF.