Clinical trial NCT00899496: Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants
Official title: Pilot Study of Cancer Resistance in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 54
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those with metastatic cancer OR healthy individuals with no prior cancer diagnosis and who are over the age of 50.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cell killing ability (positive or negative)
timeFrame: Day 180
measure: Percentage of cells killed
timeFrame: Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Zheng Cui, PhD
role: STUDY_CHAIR
References: