Clinical Trials

At Thompson we’re more than a cancer center, we’re a cancer survival center, committed to the community and determined to deliver the most advanced cancer care available.  Part of this state-of-the-art treatment may include talking to you about a clinical trial.

Thompson Cancer Survival Center was the first to bring cancer clinical trials to our area in East Tennessee over 20 years ago. Clinical trials are research studies designed to answer specific questions and find better ways to treat different types of cancer.  In fact, the reason why we have seen dramatic progress in recent years and treatments are continually getting better is because there are new drugs available as a direct result of clinical trials.

When your doctor discusses your diagnosis and your treatment options, he or she may talk to you about participating in a clinical trial. Whether or not you want to participate is always your decision. It’s important to ask questions and fully understand what the trial involves before making your decision.

Clinical trials bring the most advanced treatments to this area.

Thompson participates in clinical trials of new cancer-fighting medicines and treatments. Current trials include new therapies for cancers including brain, breast, colon, lung, kidney, gastrointestinal, prostate, melanoma, lymphoma, leukemia, and multiple myeloma.  We work with Cooperative Groups funded by the National Cancer Institute including, SWOG, NSABP, RTOG, CALGB, ECOG, NCCTG, and ACOSOG. In addition, we partner with pharmaceutical companies in order to give our patients access to new treatments that are not otherwise available.

At Thompson, we’re committed not only to providing each patient with the most advanced cancer care available, but also to leading to the cure. We offer clinical trials because it gives patients the same state-of-the-art cancer treatment they would receive if they went to any large cancer center in the country. By participating in clinical trials you are presently changing the future of cancer treatment. Be sure to learn about all of your treatment options and ask your doctor if a clinical trial might be right for you.

To learn more about currently available clinical trials at Thompson Cancer Survival Center, call the Clinical Trials Office at 541-1812 for more information.

Open trials ( Last updated 10/11/2012)

CONTACT	PHONE	ALT.  PHONE	CONTACT	PHONE	ALT. PHONE #
Missy Mynatt, RN, OCN	541-2586	Cell: 660-1059	Susan Demarcus	541-4966	597-2760
Patty Tudor, RN	541-4985(DT)	982-9558(Blount)	Melanie Blevins	531-5079 (West)	541-2391 (Downtown)
***PRIORITY STUDY	Shading = NEW STUDY	(P) = Pharma studies are available at TCSC Downtown, TOG-West, TOG-Blount and TCSC Sevier unless otherwise noted

Brain
CTSU N107C	Post-Surgical Stereotactic (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Breain Metastatic Disease: For or fewer brain metastases and status resection of one of the lesions
Breast
NSABP B-39/RTOG 0413	Stage 0, I, II: Conventional Whole Breast Irradiation versus Partial Breast Irradiation.
NSABP B-43	HER2+, DCIS Resected Lumpectomy (Herceptin (2 doses) + Radiation vs. Radiation) (Herceptin provided)
NSAB B-47	Adjuvant, HER2-Low (by IHC) Resected Node-Positive, or High-Risk Node-Negative Invasive Breast Cancer; Standard chemotherapy (TC or AC---WP) + or - Herceptin x 1 yr (provided by study)
NSAB B-49	Adjuvant, HER2 Negative, Node Positive, or High Risk Node Negative Breast Cancer; T1-3, NO-3b disease. Phase III trial comparing the combination of Docetaxel plus Cytoxan to Anthracycline based chemotherapy regimens. PS 0-1
S1007 (RX Ponder):	1st line, HER2 neg,: Adjuvant Endocrine Therapy (based on menopausal status & physician preference) +/- Chemotherapy (2nd or 3rd generation, physician choice) for pts with 1-3 + nodes, hormone receptor +, & with recurrence score of 25 or less.  Inflammatory disease permitted.
SWOG S0927	Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness in Women with Invasive Breast Adenocarcinoma-stages I, II, or III-with no evidence of metastatic disease; Pain and stiffness level of ≥ 5 on a 1-10 scale; On (Al) for at least 90 days
Gastrointestinal
NSAB P-5	Statin Polyp Prevention trial in patients with resected Colon Cancer; Stage I or II adenocarcinoma.  Surgical resection within 1 year prior to randomization; Adjuvant tx must be completed prior to randomization; No statin use within 30 days prior to randomization; Must discontinue use of NSAIDS; Rosuvastatin (Crestor) 10mg daily x 5 yrs or Placebo (provided by study).
RTOG 0436:	1st line, Unresectable Esophageal: (T1N1M0; T2-4, Any N,M0; Any T & N, M1a) Wkly Taxol +Cisplatin + XRT ± Cetuximab x 6 (Cetuximab provided; Squamous only);   Ages >/= 75yrs excluded.
CALGB 80701:	Phase II Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors:  Afinitor PO (provided by study) + Octreotide LAR +/- Avastin (provided by study) [No prior therapy with Afinitor, Avastin, or mTOR inhibitors; other prior txs allowed]
CALGB 80702:	Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer Histologically documented adenocarcinoma of the colon:  (Node positive disease (N1 or N2) as designated in AJCC version 7)
EDP 2012-1-1: RE-OPENED  as colorectal  only	Clinical Evaluation Blood Specimen Study of CA11-19 Using Patients with Untreated, Confirmed Carcinomas of the Colon-Rectum (Stage I, II, III only);  Blood draw must occur prior to any treatment, including surgery ($20 dollar gift card given to pt for study participation)
Genitourinary
RTOG 0815:	Intermediate risk Prostate: External Beam Radiation (IMRT) +/- Androgen deprivation (Intermediate risk = at least one of following: T2b-T2c, PSA >10 but ≤20, or Gleason score of 7)
CALGB 90802:	2nd line, Stage IV Metastatic or Unresectable Renal Carcinoma (clear cell component): Everolimus + Placebo vs. Everolimus + Avastin (Avastin provided); failure of ≥1 prior VEGFR TKI; no prior VEGF binding agent therapy or mTOR inhibitor; Controlled brain mets (x 3 months) allowed
LEUKEMIA/LYMPHOMA
SWOG S1117:	Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML); lenalidomide and vorinostat provided by study
ECOG E2905:	Low or Intermediate-1 Risk MDS & Symptomatic Anemia: Treatment with Revlimid ± Procrit  (All drugs provided by study)
(P) PFIZER  B1931008:	Relapsed or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who are Not Candidates for Intensive High-Dose Chemotherapy:  InotuzumabOzogamicin + Rituximab Compared to Defined Investigator’s Choice Therapy (R+Gemcitibine / R+Bendamustine) All chemotherapeutic drugs provided by study including commercial
LUNG-NSCLC
CTSU E1505:	Completely Resected Stage1B (> 4cm) - IIIA: Adjuvant Chemo (Cisplatin based) ± Avastin (Avastin provided)
SWOG S0819:	1st line, Stage IV: Taxol/Carbo/Avastin (Avastin if appropriate candidate) ± Cetuximab (Avastin ± Cetuximab maintenance follow 6 cycles chemo) (Cetuximab provided; All NSCLC histology allowed, MD discretion for Avastin appropriateness; Controlled brain mets (x 2months) allowed)
(P) DT Location Only   BMS CA184104:	Stage IV or Recurrent predominantly squamous histology NSLC; Double-blind study comparing Ipilimumab + Paclitaxel & Carboplatin vs Placebo + Paclitaxel & Carboplatin. PS 0-1; No brain mets;  No prior systemic therapy; No hx of severe autoimmune or immune related symptomatic disease; XRT allowed if performed 3 wks prior to randomization. Ipilimumab / placebo provided.
Lung-Small Cell
CALGB 30610:	Limited Stage, 1st line: Comparision of XRT regimens (1.5 Gy BID x 15 days vs 2.0 Gy daily x 35 days vs 1.8 Gy daily x 16 days followed by 1.8 Gy BID x 9 days) combined w/ Cisplatin +VP-16.
(P) DT Location Only   BMS CA184156:	Extensive Stage, Newly Diagnosed:  Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab plus Etoposide/Platinum versus Etoposide/Platinum Investigators choice of platinum (Carbo or Cisplatin); Ipilimumab provided
Head and Neck
	None available at this time.
Melanoma
ECOG 1609:	Adjuvant Ipilimumab vs.High Dose Interferon α-2b for completely resected high-risk primary cutaneous melanoma (IIIB, IIIC, or IV [mets only to skin, LN, or lung]).  XRT okay if > than 30 days.  (Ipi provided)
Multiple Myeloma
BMT-CTN 0702:	Single Autologous Transplant with or without Consolidation Therapy (Revlimid) vs. Tandem Autologous Transplant with Revlimid Maintenance for Patients with Multiple Myeloma (Mobilization not specified by study; All patients receive Revlimid maintenance--provided)