Unspecified Adult Solid Tumor, Protocol SpecificNCT00607802
Donor White Blood Cell Infusion in Treating Patients With Metastatic or Unresectable Cancer
A study testing leukocyte therapy and polymerase chain reaction in people with Unspecified Adult Solid Tumor, Protocol Specific and Unspecified Childhood Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences.
Trial summary
RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with cancer. PURPOSE: This clinical trial is studying the side effects of donor white blood cell infusion in treating patients with metastatic or unresectable cancer. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- leukocyte therapy and polymerase chain reaction
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignancy
- Metastatic or unresectable disease
- Standard curative or palliative measures do not exist or are no longer effective
- Measurable or non-measurable disease
- Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Non-measurable disease is defined as all other lesions (including small lesions and truly non-measurable lesions), including any of the following:
- Bone lesions
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- No brain metastasis
- Healthy blood donor available meeting the following criteria:
- Willing to be included in the White Cell Donor Registry created for this study
- Willing to undergo granulocyte apheresis at the American Red Cross
- ABO compatible with the patient
- HLA-mismatched with the patient
- Demonstrates ≥ 60% cytotoxic killing activity (CKA) as determined by in vitro white cell kill assay
- Less than 60% CKA allowed if deemed suitable by the investigators
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 4 months
- ANC ≥ 1,000/µL
- Platelet count > 100,000/µL (platelet transfusion independent)
- Serum bilirubin ≤ 2 mg/dL
- AST and ALT < 3 times upper limit of normal
- Serum creatinine ≤ 2 mg/dL
- No uncontrolled diabetes mellitus
- No myocardial infarction within the past 30 days
- No active serious infection
- No HIV infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Negative panel reactive antibody test (i.e., absence of serum HLA antibody)
PRIOR CONCURRENT THERAPY:
- No prior fludarabine phosphate
- No prior stem cell transplantation
- At least 4 weeks since prior medical therapy, radiotherapy, or surgery
- More than 30 days since prior immunosuppressive agents other than steroids
About this study
Official title: White Cell Transfer as Cancer Therapy
RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with cancer.
PURPOSE: This clinical trial is studying the side effects of donor white blood cell infusion in treating patients with metastatic or unresectable cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety of white blood cell infusion in patients with metastatic or unresectable cancer.
Secondary
- Determine the efficacy of this therapy in these patients.
OUTLINE: Patients receive allogeneic white blood cell infusions once daily for 5-10 infusions.
Patients undergo blood sample collection periodically for correlative laboratory studies. The samples are evaluated by in vitro white cell kill assay before the first infusion, immediately after the first infusion, on day 2, and then immediately after the last infusion to assess in vitro cancer cell killing activity. Chimerism studies are performed before the first infusion, immediately after the first infusion, and then on days 2 and 7. Complete chimerism is assayed by short tandem repeat analysis using PCR. Patients with readily accessible tumor tissue (e.g., cervical or axillary lymph nodes or subcutaneous tumor nodules) may also undergo biopsy during the first week of treatment to demonstrate the presence or absence of tumor infiltrating granulocytes.
After completion of study therapy, patients are followed periodically for 3 months.
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- leukocyte therapy, polymerase chain reaction
- Keywords
- unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leukocyte therapyBiological
polymerase chain reactionGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Secondary outcomes (1)
Response (complete response, partial response, stable disease, or disease progression)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Zheng Cui, MD, PhD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607802
- Sponsor's protocol ID
- CCCWFU-99107
- Other IDs
- CDR0000584624, IRB00002178
- Status last verified
- Jun 2013
- First submitted
- 30 Jan 2008
- Last updated
- 19 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Cell Transfer as Cancer Therapy
- ClinicalTrials.gov ID
- NCT00607802
- Acronym / sponsor ID
- CCCWFU-99107
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with cancer.
PURPOSE: This clinical trial is studying the side effects of donor white blood cell infusion in treating patients with metastatic or unresectable cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the safety of white blood cell infusion in patients with metastatic or unresectable cancer.
Secondary
- Determine the efficacy of this therapy in these patients.
OUTLINE: Patients receive allogeneic white blood cell infusions once daily for 5-10 infusions.
Patients undergo blood sample collection periodically for correlative laboratory studies. The samples are evaluated by in vitro white cell kill assay before the first infusion, immediately after the first infusion, on day 2, and then immediately after the last infusion to assess in vitro cancer cell killing activity. Chimerism studies are performed before the first infusion, immediately after the first infusion, and then on days 2 and 7. Complete chimerism is assayed by short tandem repeat analysis using PCR. Patients with readily accessible tumor tissue (e.g., cervical or axillary lymph nodes or subcutaneous tumor nodules) may also undergo biopsy during the first week of treatment to demonstrate the presence or absence of tumor infiltrating granulocytes.
After completion of study therapy, patients are followed periodically for 3 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leukocyte therapy | Biological | – |
| polymerase chain reaction | Genetic | – |
Primary outcome
Safety
1 secondary outcome
Response (complete response, partial response, stable disease, or disease progression)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zheng Cui, MD, PhD study chair
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing leukocyte therapy and polymerase chain reaction in people with Unspecified Adult Solid Tumor, Protocol Specific and Unspecified Childhood Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.