Colorectal CancerPhase 1NCT00016042
Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
A Phase 1 study testing lymphokine-activated killer cells, recombinant interferon alfa and sargramostim in people with Colorectal Cancer and Kidney Cancer, run by St. Luke's Medical Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Kidney Cancer
- What is being tested?
- lymphokine-activated killer cells, recombinant interferon alfa and sargramostim
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to not given
- Phase
- Phase 1
- 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: Histologically confirmed metastatic renal cell carcinoma or colorectal carcinoma Failed prior standard or salvage therapy OR Ineligible for standard therapy due to concurrent illness OR Declined standard therapy Bidimensionally measurable disease (by CT scan or MRI) outside prior irradiation port unless documented disease progression after radiotherapy No untreated or unstable treated brain metastasis
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Total granulocyte count at least 2,000/mm3 Hemoglobin at least 10 g/dL No coagulation disorders such as thrombophlebitis Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT/SGPT less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 3 times ULN PT/PTT no greater than 1.5 times control Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active ischemia and/or ejection fraction less than 45% No unstable angina No uncontrolled congestive heart failure Pulmonary: FEV1 or FVC greater than 65% of predicted No uncontrolled pulmonary embolism Other: No other prior malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix No active systemic infection No autoimmune disease No uncontrolled thyroid abnormalities No other major medical illness HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: More than 1 month since prior biologic therapy or immunotherapy Chemotherapy: More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: At least 4 weeks since prior steroid therapy or steroid-containing compounds At least 2 weeks since prior topical or inhaled steroids No concurrent steroids Radiotherapy: More than 1 month since prior radiotherapy, interstitial brachytherapy, or radiosurgery Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
About this study
Official title: Interleukin 12-Primed Activated T Cells For Patients With Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma (Phase I)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of fluorouracil combined with biological therapy in treating patients who have metastatic kidney or colorectal cancer.
Read the detailed description
OBJECTIVES: I. Determine the safety of fluorouracil and interleukin-12-primed activated T cells (12ATC) with sargramostim (GM-CSF) and interferon alfa in patients with metastatic renal cell cancer or colorectal cancer. II. Determine the maximum tolerated dose of 12ATC in this patient population. III. Determine the clinical response of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC). Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and undergo leukopheresis on day 6 to obtain peripheral blood mononuclear cells (PBMC). Patients treated at dose level 3 also undergo leukopheresis on day 7. The PBMC are treated with monoclonal antibody anti-CD3, interleukin-12 and interleukin-2 to form 12ATC. Patients receive chemo/immunotherapy comprising fluorouracil IV continuously over 24 hours on day 13 and GM-CSF and interferon alfa SC on days 17, 19, 21, 24, 26, and 28. Patients receive 12ATC IV over 15-30 minutes on days 31, 34, 38, 41, 45, and 48 and interferon alfa SC on days 35, 42, and 49. Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks, every 3 months for 1 year, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.
- Conditions
- Colorectal Cancer, Kidney Cancer
- Being tested
- lymphokine-activated killer cells, recombinant interferon alfa, sargramostim, fluorouracil
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV renal cell cancer, recurrent renal cell cancer
- Medical subject headings
- Colorectal Neoplasms, Kidney Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphokine-activated killer cellsBiological
recombinant interferon alfaBiological
sargramostimBiological
fluorouracilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2004 (estimated)
- Study startJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- St. Luke's Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- John P. Hanson, MD, Study chair, St. Luke's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016042
- Sponsor's protocol ID
- CDR0000068588
- Other IDs
- STLMC-IMM-0001, NCI-V01-1656
- Status last verified
- Oct 2001
- First submitted
- 6 May 2001
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin 12-Primed Activated T Cells For Patients With Metastatic Renal Cell Carcinoma Or Colorectal Carcinoma (Phase I)
- ClinicalTrials.gov ID
- NCT00016042
- Acronym / sponsor ID
- CDR0000068588
- Conditions
- Colorectal Cancer, Kidney Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- St. Luke's Medical CenterUniversity, hospital or other
- Study start
- Jan 2001
- First posted
- 5 Apr 2004 (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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of fluorouracil combined with biological therapy in treating patients who have metastatic kidney or colorectal cancer.
Detailed description
OBJECTIVES: I. Determine the safety of fluorouracil and interleukin-12-primed activated T cells (12ATC) with sargramostim (GM-CSF) and interferon alfa in patients with metastatic renal cell cancer or colorectal cancer. II. Determine the maximum tolerated dose of 12ATC in this patient population. III. Determine the clinical response of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC). Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and undergo leukopheresis on day 6 to obtain peripheral blood mononuclear cells (PBMC). Patients treated at dose level 3 also undergo leukopheresis on day 7. The PBMC are treated with monoclonal antibody anti-CD3, interleukin-12 and interleukin-2 to form 12ATC. Patients receive chemo/immunotherapy comprising fluorouracil IV continuously over 24 hours on day 13 and GM-CSF and interferon alfa SC on days 17, 19, 21, 24, 26, and 28. Patients receive 12ATC IV over 15-30 minutes on days 31, 34, 38, 41, 45, and 48 and interferon alfa SC on days 35, 42, and 49. Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks, every 3 months for 1 year, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| lymphokine-activated killer cells | Biological | – |
| recombinant interferon alfa | Biological | – |
| sargramostim | Biological | – |
| fluorouracil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
John P. Hanson, MD study chair
St. Luke's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lymphokine-activated killer cells, recombinant interferon alfa and sargramostim in people with Colorectal Cancer and Kidney Cancer, run by St. Luke's Medical Center 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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
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 20 Sep 2013.