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Protocols

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Protocols

How do I find out about NCI priorities for clinical questions in different diseases?

NCI's Cancer Therapy Evaluation Program (CTEP), Clinical Investigations Branch (CIB) organizes comprehensive programs of treatment clinical trials. Requests or questions regarding NCI priorities for clinical questions should be directed to the CIB investigator responsible for that disease area. A list of CTEP CIB staff and associated responsibilities can be found here.

How do I find out about current NCI-sponsored clinical trials?

You can search NCI's list of 8,000+ clinical trials now accepting participants.

What is the process for submitting a proposal for a phase III trial?

To submit a proposal for a phase III trial, the following steps are required:

Step 1.Use the NCI Concept Template (Microsoft Word Document) or an individual Cooperative Group template.
Step 2.Submit the concept to one or more of the NCI's cooperative groups. Each group reviews concepts internally, at the level of a disease committee, then again at a scientific prioritization committee.
Step 3.The Cooperative Group will send the concept to the relevant NCI disease-specific task force, which will provide feedback to the Group and the investigator.
Step 4.The Cooperative Group will consider the comments from the NCI disease-specific task force.
Step 5.If the Cooperative Group still wishes to proceed, they will propose the concept to the relevant NCI disease-specific steering committee. That steering committee must approve the concept for development.
Step 6.If the NCI disease-specific steering committee approves the concept, then the Cooperative Group develops a final protocol document, which must be reviewed for technical completeness by NCI.

Cancer Therapy Evaluation Program (CTEP)
Clinical Investigations Branch (CIB) Staff and Associated Responsibilities

Area of Interest

CTEP CIB Staff Member

Adolescent and Young Adult Oncology
 
Dr. Nita Louise Seibel
+1 (301) 496-2522
seibelnl@mail.nih.gov
Aging (older patients)Dr. Meg Mooney
+1 (301) 496-2522
mooneym@ctep.nci.nih.gov
AIDS Malignancies
Autologous and Allogenic Stem Cell Transplant
Dr. Richard Little
+1 (301) 435-9193
littler@mail.nih.gov
Brain Tumors (adult)Dr. Bhupinder Singh Mann
+1 (301) 496-2522
mannb@mail.nih.gov
Breast CancerDr. Jo Anne Zujewski
+1 (301) 435-9207
zujewskj@mail.nih.gov
Gastrointestinal MalignanciesDr. Jack Welch
+1 (301) 496-6512
Jack.Welch@nih.gov
GU (Prostate, Renal, Bladder, Germ Cell, Testicular)Dr. Bhupinder Singh Mann
+1 (301) 496-2522
mannb@mail.nih.gov
GynecologyDr. Jo Anne Zujewski
+1 (301) 435-9207
zujewskj@mail.nih.gov
Head and Neck (including thyroid)

Dr. Bhupinder Singh Mann
+1 (301) 496-2522
mannb@mail.nih.gov

Leukemia, Acute (adult)Dr. Richard Little
+1 (301) 435-9193
littler@mail.nih.gov
Leukemia, Chronic (adult)Dr. Richard Little
+1 (301) 435-9193
littler@mail.nih.gov
LungDr. Jack Welch
+1 (301) 496-6512
Jack.Welch@nih.gov
Lymphoma (adult)Dr. Richard Little
+1 (301) 435-9193
littler@mail.nih.gov
Melanoma, Squamous cell and other skin cancers
Mesothelioma

Dr. Howard Streicher
+1 (301) 496-1196
streicherh@ctep.nci.nih.gov

Minority Accrual

Andrea Denicoff
+1 (301) 435-9182
denicofa@mail.nih.gov

Myeloma Therapy for Hematologic MalignanciesDr. Richard Little
+1 (301) 435-9193
littler@mail.nih.gov
Neuroendocrine TumorsDr. Jack Welch
+1 (301) 496-6512
Jack.Welch@nih.gov
NutritionDr. Meg Mooney
+1 (301) 496-2522
mooneym@ctep.nci.nih.gov
Pediatric Bone tumors (e.g. Osteosarcoma, Ewing Sarcoma)
 
Dr. Nita Louise Seibel
+1 (301) 496-2522
seibelnl@mail.nih.gov
Pediatric Brain Tumors (including all PBTC protocols)Dr. Malcolm A. Smith
+1 (301) 496-2522
smithm@ctep.nci.nih.gov
Pediatric Germ Cell Tumors
Pediatric Hepatic Tumors (e.g. Hepatoblatoma)
Dr. Nita Louise Seibel
+1 (301) 496-2522
seibelnl@mail.nih.gov
Pediatric Hodgkin Disease
Pediatric Leukemia
Dr. Malcolm A. Smith
+1 (301) 496-2522
smithm@ctep.nci.nih.gov
Pediatric NeuroblastomaDr. Malcolm A. Smith
+1 (301) 496-2522
smithm@ctep.nci.nih.gov
Pediatric NHLDr. Malcolm A. Smith
+1 (301) 496-2522
smithm@ctep.nci.nih.gov
Pediatric Other Solid Tumor
Pediatric Renal Tumors (e.g. Wilms)
Pediatric Retinblastoma
Pediatric Soft Tissue Sarcoma (e.g. rhabdomyosarcoma, etc.)
Dr. Nita Louise Seibel
+1 (301) 496-2522
seibelnl@mail.nih.gov
Pediatric Transplant StudiesDr. Malcolm A. Smith
+1 (301) 496-2522
smithm@ctep.nci.nih.gov
Sarcoma (adult)Dr. Meg Mooney
+1 (301) 496-2522
mooneym@ctep.nci.nih.gov
SurgeryDr. Meg Mooney
+1 (301) 496-2522
mooneym@ctep.nci.nih.gov
Supportive Care, Health-Related Quality of Life, & Patient Reported Outcomes (PROs)

Andrea Denicoff
+1 (301) 435-9182
denicofa@mail.nih.gov

ThymomaDr. Jack Welch
+1 (301) 496-6512
Jack.Welch@nih.gov