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Pilot Study of Cancer Resistance in Humans


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Trial Information

Pilot Study of Cancer Resistance in Humans


OBJECTIVES:

- Optimize and standardize the in vitro cell kill assay using human white blood cells and
human cancer cell lines from patients with metastatic cancer and from healthy
participants.

- Determine the results of the in vitro cell kill assay in patients with metastatic
cancer and in healthy participants with no history of cancer.

OUTLINE: This is a pilot study.

Peripheral blood is obtained from healthy participants and from cancer patients. Tissue is
collected from archived samples. White blood cells are obtained from tissue and blood
samples and are assessed by the in vitro cell kill assay.

PROJECTED ACCRUAL: A total of 24 patients and 24 healthy participants will be accrued for
this study.


Inclusion Criteria:



-Meets 1 of the following criteria:

- Diagnosis of metastatic cancer including, but not limited to, any of the following:

- Stage IV non-small cell lung cancer

- Extensive-stage small cell lung cancer

- Metastatic testicular cancer

- Stage IV breast carcinoma

- Stage III or IV ovarian carcinoma

- Stage IV endometrial carcinoma

- Stage IV prostate carcinoma

- Stage IV colorectal or pancreatic cancer

- Stage IV renal cancer

- Stage III or IV non-Hodgkin's lymphoma

- Stage IV bladder cancer

- Stage III multiple myeloma (Salmon-Durie staging)

- Metastatic melanoma

- Metastatic sarcoma

- Healthy participant, meeting the following criteria:

- No prior cancer

- Over 50 years of age

Exclusion Criteria:

- Serious medical or psychiatric condition that would preclude study compliance

- Chemotherapy or radiotherapy within the past 3 months (patient)

- Prior immunosuppressive therapy or radiotherapy for any disease (healthy participant)

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Cell killing ability (positive or negative)

Safety Issue:

No

Principal Investigator

Zheng Cui, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000550086

NCT ID:

NCT00899496

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Cancer
  • stage IV bladder cancer
  • stage IV colon cancer
  • stage IV non-small cell lung cancer
  • stage IV pancreatic cancer
  • stage IV rectal cancer
  • stage IV renal cell cancer
  • stage IV melanoma
  • stage III multiple myeloma
  • extensive stage small cell lung cancer
  • stage IV adult soft tissue sarcoma
  • stage III malignant testicular germ cell tumor
  • stage IV breast cancer
  • stage IV ovarian epithelial cancer
  • stage IV prostate cancer
  • stage IV endometrial carcinoma
  • unspecified adult solid tumor, protocol specific
  • metastatic osteosarcoma
  • stage IV uterine sarcoma
  • stage III ovarian epithelial cancer
  • ovarian sarcoma
  • stage IV adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV mycosis fungoides/Sezary syndrome
  • cutaneous B-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • adult nasal type extranodal NK/T-cell lymphoma
  • Waldenstrom macroglobulinemia
  • adult grade III lymphomatoid granulomatosis
  • primary central nervous system non-Hodgkin lymphoma
  • intraocular lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096