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Cancer Care in the National Cancer Institute Center for Cancer Research

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00923065
First Posted: June 18, 2009
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

This study provides cancer care through the National Cancer Institute's Medical Oncology Branch (MOB) to patients who are not enrolled in an active treatment research protocol. Patients receive standard treatments only; no investigational therapies are provided on this protocol.

Patients 18 years of age and older may be eligible for this protocol. Candidates are patients for whom an NCI investigator decides that the interests of the patient and the NCI are best served by the patient's enrollment in this protocol to receive care and follow-up within the MOB. This includes patients in the following categories:

  • Patients previously enrolled in NCI trials whose participation in this protocol may continue to provide researchers important scientific information
  • Patients who will be eligible for a research protocol within the foreseeable future
  • Patients whose medical welfare will be seriously compromised by referral back to the community, such as patients with a rare or complex disease for which community resources are inadequate or unavailable
  • Terminally ill patients who have received most of their specialized medical care at the Clinical Center and for whom humanitarian considerations dictate that they continue to receive their medical care at NIH after going off study for the remaining weeks or months of life
  • Patients with cancer or HIV, or people at risk for cancer or HIV for whom cancer treatments at the NCI are requested through the MOB consult service
  • Patients who are participating in a non-treatment NCI research protocol and require standard-of-care therapy
  • Patients with cancer or HIV or people at risk for cancer for whom cancer treatment or management at the NCI would add significant value to the institute's cancer training program

Participants receive standard medical care, including periodic routine laboratory tests, diagnostic x-rays, and nuclear medicine scans to monitor the course of illness and the effects of any treatment.


Condition
Neoplasms

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: Care of the Adult Oncology Patient, CCR, NCI

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Primary Outcome Measures:
  • Standard of care [ Time Frame: Patient off study ]

Enrollment: 782
Study Start Date: April 20, 2004
Detailed Description:

Background:

It may be in the interest of the Center for Cancer Research (CCR) to treat and/or follow certain subjects who are not currently enrolled on an active research protocol.

Objective:

The objective of this protocol is to add value to the medical or surgical oncology training programs by providing treatment and medical follow-up for NCI patients and other Institute consult patients not currently enrolled on an active research protocol.

Eligibility:

It is in the best interests of the subject and the CCR for the subject to receive treatment or

donate cellular products at the NCI, NIH Intramural Research Program.

Design:

No investigational therapies will be administered on this study. This protocol is not a platform to perform pilot studies of off-label uses for standard agents.

This protocol will provide the administrative vehicle to provide cancer care for patients in the intramural research program.

Medical/surgical/radiotherapeutic care, treatment and follow-up is provided for subjects who are not currently enrolled on an active protocol.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Patient must be age 18 or older.

A CCR investigator decides that it is in the best interest of the patient and the CCR for the subject to receive treatment and follow-up at the NCI/NIH.

Related cell therapy donors for patients previously transplanted on an NCI trial who require non-investigational diagnostic studies and/or therapies for transplant-related complications that arise urgently and/or are unable to be addressed on an existing NIH treatment protocol or by providers outside the NIH.

Volunteer unrelated donors may donate cellular therapy products to patients on this protocol. Volunteer unrelated donors will not enroll on this protocol and unrelated donor evaluation, suitability and eligibility determination, and collection takes place at National Marrow Donor Program (NMDP)-affiliated centers or cooperative registries in accordance with the most recent FDA, NMDP, and AABB regulations and standards. NMDP network standards and processes are covered by the NIH NMDP Transplant Center Agreement, and the latest version of the NMDP Standards.

The patient or their Legally Authorized Representative is able and willing to provide informed consent. Note, participants who can expect to receive no direct benefit on this study (i.e. donors) may not consent through an LAR.

EXCLUSION CRITERIA:

Participants who are receiving an investigational therapy.

Donor participants who unable to provide the informed consent.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923065


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: James L Gulley, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00923065     History of Changes
Obsolete Identifiers: NCT00898625
Other Study ID Numbers: 040165
04-C-0165
First Submitted: June 17, 2009
First Posted: June 18, 2009
Last Update Posted: November 24, 2017
Last Verified: November 13, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Cancer
Oncology
Standard Care