Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants

Overview

RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer and from healthy participants may help doctors learn more about cancer. PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in patients with metastatic cancer and in healthy participants.

Full Title of Study: “Pilot Study of Cancer Resistance in Humans”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 23, 2009

Detailed Description

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.

Interventions

  • Other: immunological diagnostic method
  • Other: physiologic testing

Clinical Trial Outcome Measures

Primary Measures

  • Cell killing ability (positive or negative)
    • Time Frame: Day 180
  • Percentage of cells killed
    • Time Frame: Day 180

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Wake Forest University Health Sciences
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zheng Cui, PhD, Study Chair, Wake Forest University Health Sciences

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