| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Kidney Cancer - Melanoma (Skin) - Ovarian Cancer - Unspecified Adult Solid Tumor, Protocol Specific |
| Purpose: |
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RATIONALE: Collecting and storing samples of blood, stem cells, and tumor tissue from
patients with cancer, and blood samples from healthy volunteers, to test in the laboratory
may help the study of cancer in the future. It may also help doctors determine whether
patients are eligible for future biological therapy clinical trials.
PURPOSE: This laboratory study is collecting cells from patients with cancer and from
healthy volunteers for future NCI Surgery Branch biological therapy clinical trials.
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| Study summary: |
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OBJECTIVES:
- Obtain autologous blood, stem cells, and/or tumor tissue from patients with cancer for
expansion and analysis of tumor reactivity as preliminary assessment of eligibility for
research or future NCI Surgery Branch adoptive cell therapy protocols, or for specimen
banking for future use in research.
- Obtain allogeneic peripheral blood mononuclear cells from healthy volunteers for ex
vivo generation of allogeneic antitumor lymphocytes.
OUTLINE: Patients undergo apheresis and/or biopsy to obtain peripheral blood mononuclear
cells (PBMC) and/or tumor-infiltrating lymphocytes (TIL), respectively. Some patients may
also receive filgrastim (G-CSF)subcutaneously (SC) twice daily and undergo autologous
apheresis beginning on day 5 of filgrastim (G-CSF) administration. G-CSF and apheresis may
repeat daily for up to 3 days to obtain an adequate number of stem cells. PBMC are also
collected from healthy volunteers . Cells are expanded, analyzed for tumor reactivity and
cell viability, and evaluated for patient suitability for NCI adoptive cell therapy
protocols. Specimens collected may be banked for use in adoptive cell therapy research.
PROJECTED ACCRUAL: A total of 2500 participants (1,500 patients and 1,000 healthy
volunteers) will be accrued for this study. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Meets criteria for 1 of the following:
- Patient with diagnosis of a cancer currently being studied in a Surgery Branch
adoptive cell therapy protocol (e.g., melanoma, renal cell carcinoma, or ovarian
cancer)
- Healthy volunteer
- No participation in any high-risk sexual or illegal drug activities (e.g.,
prostitution, sexual contact with persons at high risk for HIV, use of
needles) or long incarceration in jail or prison
- No body piercing or tattoos within the past year
- No travel outside of the United States to a restricted country (i.e.,
country considered endemic for high-risk communicable disease) within the
past year
- No swollen glands, night sweats, purple skin lesions, or white spots in
mouth
- No whole blood or blood component donations within the past month
- No problems with prior blood donations
- Not pregnant within the past 6 weeks
- Seronegative for HBsAg, Anti-HBc, Anti-HCV, Anti-HIV-1/2, HIV-1/HCV NAT,
anti-HTLV-1/2, RPR, T. cruzi, anti-CMV IgG and IgM, and West Nile Virus NAT
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 3 months
Hematopoietic
- No coagulation disorder or bleeding abnormality (patients and healthy volunteers)
Hepatic
- Hepatitis B surface antigen and hepatitis C antibody negative (patients)
- No jaundice, liver disease, or hepatitis (healthy volunteers)
Renal
- No kidney disease (healthy volunteers)
Cardiovascular
- No major cardiovascular illness (patients)
- No chest pain, heart disease, irregular heartbeat, or hypertension (healthy
volunteers)
Pulmonary
- No major respiratory illness (patients)
Other
- Must be Epstein Barr virus titer positive (patients)
- Human T-cell lymphotrophic virus type 1 negative (healthy volunteers)
- HIV negative (patients and healthy volunteers)
- No active systemic infection (patients)
- No other major immune system illness (patients and healthy volunteers)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Concurrent surgery to obtain tumor-infiltrating lymphocytes allowed, provided the
procedure is associated with minimal morbidity and minimal hospitalization
Other
- No prior treatment for diabetes (healthy volunteers)
- No participation in any other protocol within the past 8 weeks (healthy volunteers) |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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December 30, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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