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

Wake Forest University (WFU)

Status: Completed

Conditions: Cancer

Treatments: Other: physiologic testing; Other: immunological diagnostic method

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00899496

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU 95A05

CCCWFU-99A05

CCCWFU-BG05-342

Details and patient eligibility

About

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 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.

Enrollment: 54 patients

Sex: All

Ages: Under 120 years old

Volunteers: Accepts Healthy Volunteers

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)