Kidney CancerPhase 2NCT00093522
Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer
A Phase 2 study testing autologous tumor cell vaccine, keyhole limpet hemocyanin and therapeutic autologous dendritic cells in people with Kidney Cancer, run by St. Luke's Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- autologous tumor cell vaccine, keyhole limpet hemocyanin and therapeutic autologous dendritic cells
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to not given
- 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:
- Histologically confirmed renal cell carcinoma
- Stage IV disease
- Received no benefit from standard therapy OR ineligible for standard therapy OR declined standard therapy
- At least 1 site of metastatic disease that can be surgically removed AND at least 1 site of metastatic disease than can remain in the patient (indicator lesion) after surgery
- Total volume of the site or sites of disease to be surgically removed must be > 2.0 cm^3
- Unidimensionally measurable disease
- At least 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 6 months
Hematopoietic
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 10 g/dL
Hepatic
- SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Hepatitis C antibody negative
- Hepatitis B surface antigen negative
Renal
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance > 40 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Immunologic
- Coomb's test negative
- HIV-1 and -2 negative
- No active infection
- No unexplained fever (temperature > 100.5° F or 38.1°C)
- No lymphocytopenia
- No hypogammaglobulinemia
- No autoimmune disease or other immunocompromising condition that would preclude study participation
- No history of impaired immune response
- No history of tuberculosis OR positive PPD skin test
- No history of allergic reaction attributed to compounds of similar biological composition to study vaccine
- No history of allergic reaction to antibiotics
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after study participation
- No psychiatric illness or social situation that would preclude study participation
- No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix
- No other concurrent illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior immunotherapy
Chemotherapy
- More than 4 weeks 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
Radiotherapy
- More than 4 weeks since prior radiotherapy
Surgery
- See Disease Characteristics
Other
- More than 4 weeks since prior investigational agents
- More than 1 week since prior antibiotics
- No concurrent renal dialysis
- No concurrent anticoagulants
- No other concurrent anticancer agents or therapies
- No other concurrent investigational agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Midwest Heart Surgery Institute, Limited
Milwaukee, Wisconsin, 53215
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
About this study
Official title: A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with fludarabine may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and fludarabine to see how well they work compared to vaccine therapy alone in treating patients with stage IV kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the safety of vaccination comprising autologous dendritic cells loaded with autologous tumor lysate and keyhole limpet hemocyanin with vs without non-myeloablative fludarabine in patients with stage IV renal cell carcinoma.
- Compare, preliminarily, the efficacy of these regimens in these patients.
- Compare the overall survival of patients treated with these regimens.
Secondary
- Determine whether this vaccine induces tumor-reactive peripheral T-cell responses or delayed-type hypersensitivity in these patients.
OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo surgery to remove tumor at metastatic sites to generate autologous tumor lysate. Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells for the generation of dendritic cells (DC). The DC are then exposed to autologous tumor lysate and keyhole limpet hemocyanin (KLH).
- Arm I: Three weeks after leukapheresis, patients receive vaccination comprising DC loaded with autologous tumor lysate and KLH (DC vaccine) intradermally once every 14 days for a total of 4 injections in the absence of disease progression or unacceptable toxicity.
- Arm II: Two weeks after leukapheresis, patients receive fludarabine IV over 15-30 minutes once daily for 3 days. Beginning approximately 5 weeks after leukapheresis, patients also receive DC vaccine as in arm I.
Patients are followed at 1, 3, and 7-9 weeks, at 4, 6, 9, and 12 months, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this study within 2-3 years.
- Conditions
- Kidney Cancer
- Being tested
- autologous tumor cell vaccine, keyhole limpet hemocyanin, therapeutic autologous dendritic cells, fludarabine phosphate, conventional surgery
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous tumor cell vaccineBiological
keyhole limpet hemocyaninBiological
therapeutic autologous dendritic cellsBiological
conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by NCI common toxicity table at completion of study
Response as measured by RECIST guidelines and the Kaplan-Meier method at 5 years
Survival as measured by the Kaplan-Meier method at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2004 (estimated)
- Study startAug 2004
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
- Treatment
- Allocation
- Randomised
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- John P. Hanson, MD, Principal investigator, St. Luke's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093522
- Sponsor's protocol ID
- CDR0000389145
- Other IDs
- STLMC-IMM-03-05, STLMC-L-03-138
- Status last verified
- May 2007
- First submitted
- 6 Oct 2004
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00093522
- Acronym / sponsor ID
- CDR0000389145
- Conditions
- Kidney Cancer
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- St. Luke's Medical CenterUniversity, hospital or other
- Study start
- Aug 2004
- First posted
- 8 Oct 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: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with fludarabine may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and fludarabine to see how well they work compared to vaccine therapy alone in treating patients with stage IV kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the safety of vaccination comprising autologous dendritic cells loaded with autologous tumor lysate and keyhole limpet hemocyanin with vs without non-myeloablative fludarabine in patients with stage IV renal cell carcinoma.
- Compare, preliminarily, the efficacy of these regimens in these patients.
- Compare the overall survival of patients treated with these regimens.
Secondary
- Determine whether this vaccine induces tumor-reactive peripheral T-cell responses or delayed-type hypersensitivity in these patients.
OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo surgery to remove tumor at metastatic sites to generate autologous tumor lysate. Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells for the generation of dendritic cells (DC). The DC are then exposed to autologous tumor lysate and keyhole limpet hemocyanin (KLH).
- Arm I: Three weeks after leukapheresis, patients receive vaccination comprising DC loaded with autologous tumor lysate and KLH (DC vaccine) intradermally once every 14 days for a total of 4 injections in the absence of disease progression or unacceptable toxicity.
- Arm II: Two weeks after leukapheresis, patients receive fludarabine IV over 15-30 minutes once daily for 3 days. Beginning approximately 5 weeks after leukapheresis, patients also receive DC vaccine as in arm I.
Patients are followed at 1, 3, and 7-9 weeks, at 4, 6, 9, and 12 months, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this study within 2-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
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 |
|---|---|---|
| autologous tumor cell vaccine | Biological | – |
| keyhole limpet hemocyanin | Biological | – |
| therapeutic autologous dendritic cells | Biological | – |
| fludarabine phosphate | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Safety as measured by NCI common toxicity table at completion of study
Response as measured by RECIST guidelines and the Kaplan-Meier method at 5 years
Survival as measured by the Kaplan-Meier method at 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
Related trials for Kidney Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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 principal investigator
St. Luke's Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous tumor cell vaccine, keyhole limpet hemocyanin and therapeutic autologous dendritic cells in people with Kidney Cancer, run by St. Luke's Medical Center at 2 sites 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 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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.
What does the primary outcome measure?
Safety as measured by NCI common toxicity table at completion of study. 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 19 Dec 2013.