Priority Lists
Protocol Posting of
Activations
Activation
Phase III Rituxan/BEAM vs. Bexxar/BEAM with Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkin’s Lymphoma
| Study Coordinator(s) | Oliver W. Press, M.D.,Ph.D. |
| Participants | Limited Institutions: BMT Members |
Closures
Permanent Closure effective 2/9/07
A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec TM) versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumor (GIST)
| Study Coordinator(s) | John Vetto, M.D. |
| Participants | CTSU |
| Closure Date | 2007-02-09 |
Permanent Closure effective 3/1/07
Randomized Phase III Trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in Patients with Extensive Stage Small Cell Lung Cancer
| Study Coordinator(s) | Ronald B. Natale, M.D., David R. Gandara, M.D., Primo N. Lara, Jr., M.D., Heinz- Josef Lenz, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU |
| Closure Date | 2007-03-01 |
Permanent Closure effective 2/15/07
A Prospective Observational Study of Patients with Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan
| Study Coordinator(s) | Andrzej J. Jakubowiak, M.D.,Ph.D., J. Sybil Biermann, M.D., Paul Okunieff, M.D., Ronald C. Walker, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Radiation Oncologists, Pathologists |
| Closure Date | 2007-02-15 |
Amendments, Revisions, Memoranda
Memorandum
A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571)(NSC # 716051,IND # 61135), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG
| Study Coordinator(s) | Margaret R. O'Donnell, M.D. |
| Participants | Members, NCORP, Medical Oncologists |
Amendment #7
A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
| Study Coordinator(s) | Silvana Martino, D.O. |
Memorandum
A Phase II Study of Pemetrexed Disodium (ALIMTA) Plus Bevacizumab in Patients with Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)
| Study Coordinator(s) | Ralph G Zinner, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU for Anaplastic Astrocytoma (IND #60,265)
| Study Coordinator(s) | Geoffrey R. Barger, M.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum
"Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)"
| Study Coordinator(s) | George Demetri, M.D., Christopher Fletcher, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Surgeons, Pathologists, CALGB, ECOG, NCIC-CTG |
Memorandum
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
| Study Coordinator(s) | Julie R. Gralow, M.D., Robert B. Livingston, M.D., Daniel F. Hayes, M.D., Dawn Hershman, M.D., M.S., Alison T. Stopeck, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, Pathologists, CTSU |
Memorandum
A Phase II Trial of STI-571/Imatinib (Gleevec®) (NSC-716051) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)
| Study Coordinator(s) | Wolfram E. Samlowski, M.D., Ralph J. Tuthill, M.D., Michael C. Heinrich, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, ECOG |
Memorandum
A Phase II Study of Imatinib (NSC-716051) in Patients with Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans
| Study Coordinator(s) | Scott Schuetze, M.D.,Ph.D., Brian Rubin, M.D.,Ph.D., Michael C. Heinrich, M.D., Vivien Bramwell, M.D.,Ph.D., George Demetri, M.D., Margaret von Mehren, M.D. |
| Participants | Members, NCORP, Medical Oncologists, CTSU |
Memorandum
A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, with and without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients with Advanced Oropharyngeal Squamous Cell Cancer
| Action Codes | NR |
| Study Coordinator(s) | David J. Adelstein, M.D., Gregory T. Wolf, M.D., P.G. Shankar Giri, M.D., Adel K. El-Naggar, M.D., Ph.D, Peggy A. Carroll, R.N. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, CTSU |
Revision #2
A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, with and without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients with Advanced Oropharyngeal Squamous Cell Cancer
| Action Codes | NR |
| Study Coordinator(s) | David J. Adelstein, M.D., Gregory T. Wolf, M.D., P.G. Shankar Giri, M.D., Adel K. El-Naggar, M.D., Ph.D, Peggy A. Carroll, R.N. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Radiation Oncologists, Surgeons, Pathologists, CTSU |
Memorandum
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
| Study Coordinator(s) | Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States |
Revision #1
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
| Study Coordinator(s) | Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU Institutions in the United States |
Memorandum
A Phase II Study of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
| Action Codes | ER |
| Study Coordinator(s) | Linda L. Garland, M.D., Antoinette J. Wozniak, M.D., Harvey I. Pass, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists |
Memorandum
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
| Study Coordinator(s) | Alison T. Stopeck, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma
| Study Coordinator(s) | Mark H. Kirschbaum, M.D., Jasmine M. Zain, M.D., Lisa M. Rimsza, M.D., Raymond R. Tubbs, D.O. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Memorandum
Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
| Study Coordinator(s) | Steven Bernstein, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
| Action Codes | ER |
| Study Coordinator(s) | Antoinette J. Wozniak, M.D., Charles R. Thomas Jr., M.D., Karen Kelly, M.D., Laurie E. Gaspar, M.D., Philip C. Mack, Ph.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
| Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #3
A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed by Cetuximab and Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer
| Study Coordinator(s) | Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists |
Revision #13
Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer, Phase III.
| Study Coordinator(s) | Daniel P. Petrylak, M.D., Jeffrey A. Jones, M.D., Maha H.A. Hussain, M.D., Donna L. Berry, R.N.,Ph.D. |
| Participants | UCOP, Medical Oncologists, Surgeons, CALGB, NCCTG, EPP, NCORP, Members, CTSU |
Revision #17
Adjuvant Androgen Deprivation Versus Mitoxantrone Plus Prednisone Plus Androgen Deprivation in Selected High Risk Prostate Cancer Patients Following Radical Prostatectomy, Phase III.
| Study Coordinator(s) | L. Michael Glode, M.D., Maha H.A. Hussain, M.D., Gregory P. Swanson, M.D., David P. Wood Jr., M.D., Wael A. Sakr, M.D. |
| Participants | Members, NCORP, Affiliates, UCOP, Medical Oncologists, Surgeons, Radiation Oncologists, Pathologists, EPP, CALGB, CTSU Institutions in the United States |
Revision #10
Lung Cancer Specimen Repository Protocol, Ancillary
| Action Codes | ER |
| Study Coordinator(s) | Wilbur A. Franklin, M.D., Paul H. Gumerlock, Ph.D., David R. Gandara, M.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, CTSU, NCIC-CTG, ECOG |
Other New Items
- IP - Pts Must Be Informed
- AC - Consent Must Be Amended
- CBR - No Registration Allowed until IRB Review
- RC - Formal Re-consent Required
- FBR - Full Board Review Required
- ER - Expedited Review Acceptable
- NR - No IRB Review Required