Kidney CancerPhase 2NCT00316901
Positron Emission Tomography and CT Scan in Predicting Response in Patients With Metastatic Melanoma or Kidney Cancer Who Are Undergoing Cellular Adoptive Immunotherapy on a Surgery Branch Clinical Trial
A Phase 2 study testing computed tomography, positron emission tomography and fludeoxyglucose F 18 in people with Kidney Cancer and Melanoma (Skin), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography scan (done before and after cellular adoptive immunotherapy), may help doctors predict a patient's response to treatment and help plan the best treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Melanoma (Skin)
- What is being tested?
- computed tomography, positron emission tomography and fludeoxyglucose F 18
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2007
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Melanoma
- Renal cell cancer
- Metastatic disease
- Measurable disease by CT scan or MRI
- Enrolled in a Surgery Branch protocol utilizing 1 of the following variations of adoptive cell transfer of tumor-infiltrating lymphocytes (TIL):
- Intravenous (IV) TIL after a nonmyeloablative preparative regimen (e.g., NCI-99-C-0158)
- Intra-arterial (IA) TIL after a nonmyeloablative preparative regimen (e.g., NCI-99-C-0158)
- IV TIL after a myeloablative preparative regimen with chemotherapy and total-body irradiation (e.g., NCI-04-C-0288)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- No history of or treatment for diabetes mellitus
- No hypersensitivity or allergy to fludeoxyglucose F 18
- Weight ≤ 350 lbs (136 kg)
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No treatment with both IV and IA TIL
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
About this study
Official title: PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols
RATIONALE: Diagnostic procedures, such as positron emission tomography and computed tomography scan (done before and after cellular adoptive immunotherapy), may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well positron emission tomography and computed tomography scan predicts response in patients with metastatic melanoma or kidney cancer who are undergoing cellular adoptive immunotherapy on a Surgery Branch clinical trial.
Read the detailed description
OBJECTIVES:
Primary
- Measure changes in metabolic activity at visceral sites during the acute treatment phase of adoptive cell transfer (ACT) using positron emission tomography (PET)/CT fusion imaging in patients with metastatic melanoma or renal cell cancer.
- Measure changes in metabolic activity at metastatic sites during the acute treatment phase of ACT using PET/CT fusion imaging.
- Compare the changes in metabolic activity at visceral and metastatic sites in patients treated with intravenous vs intra-arterial tumor-infiltrating lymphocyte infusions.
Secondary
- Correlate response of individual metastases with these metabolic alterations.
OUTLINE: This is a pilot study. Patients are stratified according to treatment (intravenous [IV] tumor-infiltrating lymphocytes [TIL] after a nonmyeloablative preparative regimen vs intra-arterial [IA] TIL after a nonmyeloablative preparative regimen vs IV TIL after a myeloablative preparative regimen with chemotherapy and total-body irradiation).
Patients undergo positron emission tomography with fludeoxyglucose F 18 (FDG-PET)/CT fusion imaging at baseline (before starting TIL infusion), once between days 1-4 after TIL infusion, and once between days 5-8 after TIL infusion.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
- Conditions
- Kidney Cancer, Melanoma (Skin)
- Being tested
- computed tomography, positron emission tomography, fludeoxyglucose F 18
- Keywords
- stage IV renal cell cancer, stage IV melanoma, recurrent melanoma, recurrent renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Melanoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyProcedure or surgery
positron emission tomographyProcedure or surgery
fludeoxyglucose F 18Radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic activity at visceral sites
Metabolic activity at metastatic sites
Differences in metabolic activity at visceral and metastatic sites in patients treated with intravenous and intraarterial cell infusions
Secondary outcomes (1)
Response of individual metastases in comparison with metabolic alterations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Richard E. Royal, MD, FACS, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316901
- Sponsor's protocol ID
- 060099
- Other IDs
- 06-C-0099, NCI-P6831, CDR0000470868
- Status last verified
- Mar 2012
- First submitted
- 19 Apr 2006
- Last updated
- 15 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols
- ClinicalTrials.gov ID
- NCT00316901
- Acronym / sponsor ID
- 060099
- Conditions
- Kidney Cancer, Melanoma (Skin)
- Keywords
- stage IV renal cell cancer, stage IV melanoma, recurrent melanoma, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Apr 2006 (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: Diagnostic procedures, such as positron emission tomography and computed tomography scan (done before and after cellular adoptive immunotherapy), may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well positron emission tomography and computed tomography scan predicts response in patients with metastatic melanoma or kidney cancer who are undergoing cellular adoptive immunotherapy on a Surgery Branch clinical trial.
Detailed description
OBJECTIVES:
Primary
- Measure changes in metabolic activity at visceral sites during the acute treatment phase of adoptive cell transfer (ACT) using positron emission tomography (PET)/CT fusion imaging in patients with metastatic melanoma or renal cell cancer.
- Measure changes in metabolic activity at metastatic sites during the acute treatment phase of ACT using PET/CT fusion imaging.
- Compare the changes in metabolic activity at visceral and metastatic sites in patients treated with intravenous vs intra-arterial tumor-infiltrating lymphocyte infusions.
Secondary
- Correlate response of individual metastases with these metabolic alterations.
OUTLINE: This is a pilot study. Patients are stratified according to treatment (intravenous [IV] tumor-infiltrating lymphocytes [TIL] after a nonmyeloablative preparative regimen vs intra-arterial [IA] TIL after a nonmyeloablative preparative regimen vs IV TIL after a myeloablative preparative regimen with chemotherapy and total-body irradiation).
Patients undergo positron emission tomography with fludeoxyglucose F 18 (FDG-PET)/CT fusion imaging at baseline (before starting TIL infusion), once between days 1-4 after TIL infusion, and once between days 5-8 after TIL infusion.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| computed tomography | Procedure or surgery | – |
| positron emission tomography | Procedure or surgery | – |
| fludeoxyglucose F 18 | Radiation | – |
Primary outcome
Metabolic activity at visceral sites
Metabolic activity at metastatic sites
Differences in metabolic activity at visceral and metastatic sites in patients treated with intravenous and intraarterial cell infusions
1 secondary outcome
Response of individual metastases in comparison with metabolic alterations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
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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.
Richard E. Royal, MD, FACS principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing computed tomography, positron emission tomography and fludeoxyglucose F 18 in people with Kidney Cancer and Melanoma (Skin), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Metabolic activity at visceral sites. The study lists 3 primary outcomes in all. 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 15 Mar 2012.