NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Cell Harvest and Preparation for Surgery Branch Treatment Protocols

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

03-C-0277

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Fetuses;
Children;
Adults who are or may become unable to consent;
Pregnant Women

Keywords

Adoptive Cell Therapy;
Screening;
Cell Harvest;
Blood;
Tumor Tissue;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Melanoma;
Gastrointestinal Cancer;
Metastatic Cancer;
Breast Cancer;
Non-Small Cell Lung Cancer

Investigational Drug(s)

Anti-CD19 CAR PBL
Young TIL

Investigational Device(s)

None

Intervention(s)

Drug: Anti-CD19 CAR PBL

Supporting Site

National Cancer Institute

Background:

The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.

Objective:

This study will collect white blood cells from normal volunteers and white blood cells and/or tumor cells, from patients who have been screened for and are eligible for a NCI Surgery Branch treatment protocol. The cells collected from normal volunteers will be used as growth factors for the cells during the period of laboratory growth. The cells and/or tumor from patients will be used to make the cell treatment product.

Eligibility:

Patients must be eligible for a NCI Surgery Branch Treatment Protocol

Normal Volunteers must meet the criteria for blood donation

Design

Both patients and normal Volunteers will undergo apheresis. Patients will then undergo further testing as required by the treatment protocol.

There is no required follow up for normal volunteers.

--Back to Top--

Eligibility

ELIGIBILITY CRITERIA FOR PATIENTS WITH A CURRENT DIAGNOSIS OF CANCER:

INCLUSION CRITERIA:

- Patients must have a form of cancer currently being studied in the NCI-SB.

- Patient is able to understand and willing to sign a written informed consent document.

- Age greater than or equal to 18 years.

- Clinical performance status of ECOG 0 or 1.

- Serology

-- Seronegative for HIV antibody. (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities).

-- Seronegative for hepatitis B surface antigen and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.

- Lesions which will be harvested for the generation of TIL should be accessible via standard surgical or radiological techniques and be associated with acceptable morbidity.

EXCLUSION CRITERIA:

- Active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system.

- Patients who cannot give proper informed consent to the experimental therapy due to an active psychiatric disorder or inability to understand the nature of the proposed therapy and attendant risk.

- Women of child-bearing potential who are pregnant because of the potentially dangerous effects of some of the procedures (e.g., tumor biopsy or surgery for tumor resection) on the fetus.

ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS:

INCLUSION CRITERIA for PBMC Donors:

- Age greater than or equal to 18 years.

- Non-reactive for HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2, HBV/HCV/HIV-1 NAT, anti-HTLV-I/II, anti-T. cruzi, West Nile Virus NAT,syphilis, and babesia.

- PBMC donors must meet the strict behavioral and medical history requirements as per applicable NCI-SB Apheresis Donor SOP(s).

INCLUSION CRITERIA FOR WHOLE BLOOD DONORS:

- Age greater than or equal to 18 years.

- Whole blood donors must meet the DTM inclusion criteria for allogeneic whole blood donation.

EXCLUSION CRITERIA for PBMC Donors:

- Has had babesiosis.

- Is at risk or has Creutzfeldt-Jakob Disease.

- Is on steroid therapy or any other medication or has received vaccination that might interfere with cell preparation per Principal Investigator s (PI) discretion.

- Has ongoing illness that would cause harm to the volunteer during the apheresis procedure as determined by the PI.

- Has had yellow jaundice, liver disease, or hepatitis since the age of 11.

- Has uncontrolled diabetes.

- Has a hematologic malignancy or any bleeding abnormalities.

- Has received any type of organ transplant in the past 12 months.

- Has undergone xenotransplantation at any time.

- Has received a dura mater graft.

- If female, is pregnant or has given birth within the last six weeks.

- Has had an ear or body piercing or tattoos within the past 12 months.

- Has had a blood transfusion within the past 12 months.

- Has spent time outside the United States to a restricted country.

- Has participated in any high-risk activities.

EXCLUSION CRITERIA for Whole Blood Donors:

- Whole blood donors who do not meet the DTM criteria for allogeneic whole blood donation.


--Back to Top--

Citations:

Dudley ME, Wunderlich JR, Robbins PF, Yang JC, Hwu P, Schwartzentruber DJ, Topalian SL, Sherry R, Restifo NP, Hubicki AM, Robinson MR, Raffeld M, Duray P, Seipp CA, Rogers-Freezer L, Morton KE, Mavroukakis SA, White DE, Rosenberg SA. Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science. 2002 Oct 25;298(5594):850-4. Epub 2002 Sep 19.

Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013 Mar 29;339(6127):1546-58. doi: 10.1126/science.1235122.

Robbins PF, Lu YC, El-Gamil M, Li YF, Gross C, Gartner J, Lin JC, Teer JK, Cliften P, Tycksen E, Samuels Y, Rosenberg SA. Mining exomic sequencing data to identify mutated antigens recognized by adoptively transferred tumor-reactive T cells. Nat Med. 2013 Jun;19(6):747-52. doi: 10.1038/nm.3161. Epub 2013 May 5.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Steven A. Rosenberg, M.D.
National Cancer Institute (NCI)



NCI SB Immunotherapy Recruitment Center
National Cancer Institute (NCI)

(866) 820-4505
irc@nih.gov

Recruitment Center - SB
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Building 10, Room 2-1730, Bethesda, Maryland 20892, United States
(866) 820-4505
ncisbirc@mail.nih.gov

Clinical Trials Number:

NCT00068003

--Back to Top--