Kidney CancerPhase 2NCT00003664
Combination Chemotherapy and Biological Therapy In Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed Surgically
A Phase 2 study testing aldesleukin, recombinant interferon alfa and fluorouracil in people with Kidney Cancer, run by Cancer Biotherapy Research Group at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- aldesleukin, recombinant interferon alfa and fluorouracil
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 1998to 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable carcinoma of the kidney No CNS metastases
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Greater than 4 months Hematopoietic: WBC at least 3,500/mm3 Granulocyte count at least 2,500/mm3 Platelet count at least 100,000/mm3 PT no greater than 1.3 times upper limit of normal (ULN) Hematocrit at least 28% Hepatic: Bilirubin less than 2.0 mg/dL SGOT no greater than 1.25 times ULN (unless due to tumor) Renal: Creatinine less than 2.0 mg/dL Calcium less than 12 mg/dL Proteinuria no greater than 2.0 by dipstick Cardiovascular: No active angina No uncontrolled congestive heart failure No uncontrolled arrhythmias No myocardial infarction within 6 months Pulmonary: No significant pulmonary disease (RA pO2 less than 60 or pCO2 greater than 50) Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection No daily emesis or inability to tolerate solid foods No prior or concurrent second malignancy within 2 years, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No sever diarrhea (greater than 4 watery stools per day) No active pelvic inflammatory disease No inflammatory bowel disease No uncontrolled seizure disorders No personal or family history of malignant hyperthermia No recent thromboembolism or any condition requiring concurrent anticoagulation
PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent biologic therapy Chemotherapy: No prior gemcitabine No prior fluorouracil other than adjuvant fluorouracil received at least 1 year prior to study No other concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids not allowed (except for nausea or vomiting) Radiotherapy: At least 14 days since prior radiation to axial skeleton No concurrent radiotherapy (except to local lesions) Surgery: At least 14 days since prior exploration and biopsy At least 21 days since prior resection with anastomosis No major organ allograft Other: No concurrent barbiturates No concurrent oral anticoagulants No other concurrent investigational drugs or devices
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bloomington Hospital
Bloomington, Indiana, 47402
Bergan Mercy Medical Center
Omaha, Nebraska, 68124
About this study
Official title: Combination Chemobiotherapy With Gemcitabine, 5-Fluorouracil, Interleukin-2 and Alpha Interferon in Patients With Metastatic or Unresectable Renal Cell Cancer. A Phase II Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with biological therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and biological therapy in treating patients with kidney cancer that is metastatic or cannot be removed surgically.
Read the detailed description
OBJECTIVES: I. Determine the toxic effects of interferon alfa, interleukin-2, gemcitabine, and fluorouracil in patients with metastatic or unresectable renal cell cancer. II. Evaluate the feasibility and possible therapeutic anticancer efficacy of this therapy in these patients. III. Determine the duration of response, survival, and improvement of quality of life in these patients.
OUTLINE: Patients receive fluorouracil IV on days 1, 8, 15, and 22, followed by gemcitabine IV over 30 minutes on days 29, 36, 43, and 50. Interferon alfa is administered subcutaneously 3 times weekly beginning on day 1. Beginning on day 2, interleukin-2 is administered subcutaneously 3 times weekly for the first 4 weeks of the treatment course. Treatment is repeated every 8 weeks for up to 4 courses in the absence of unacceptable toxic effects and disease progression. Following chemobiotherapy, maintenance therapy is administered to patients with stable or responding disease. Patients receive subcutaneous interferon alfa 3 times weekly at the maximum tolerated dose until disease progression or for a maximum of 1 year. A quality of life assessment is completed weekly. Patients are followed until death.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18-24 months.
- Conditions
- Kidney Cancer
- Being tested
- aldesleukin, recombinant interferon alfa, fluorouracil, gemcitabine hydrochloride
- Keywords
- stage IV renal cell cancer, recurrent 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.
aldesleukinBiological
recombinant interferon alfaBiological
fluorouracilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2004 (estimated)
- Study startOct 1998
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
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Biotherapy Research Group
- Sponsor type
- University, hospital or other
- Investigators
- Gamini S. Soori, MD, FACP, FRCP, MBA, Study chair, Cancer Biotherapy Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003664
- Sponsor's protocol ID
- CDR0000066757
- Other IDs
- CBRG-9808, NCI-V98-1493
- Status last verified
- Sep 2000
- First submitted
- 1 Nov 1999
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Chemobiotherapy With Gemcitabine, 5-Fluorouracil, Interleukin-2 and Alpha Interferon in Patients With Metastatic or Unresectable Renal Cell Cancer. A Phase II Study
- ClinicalTrials.gov ID
- NCT00003664
- Acronym / sponsor ID
- CDR0000066757
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Biotherapy Research GroupUniversity, hospital or other
- Study start
- Oct 1998
- First posted
- 16 Jul 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 tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with biological therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and biological therapy in treating patients with kidney cancer that is metastatic or cannot be removed surgically.
Detailed description
OBJECTIVES: I. Determine the toxic effects of interferon alfa, interleukin-2, gemcitabine, and fluorouracil in patients with metastatic or unresectable renal cell cancer. II. Evaluate the feasibility and possible therapeutic anticancer efficacy of this therapy in these patients. III. Determine the duration of response, survival, and improvement of quality of life in these patients.
OUTLINE: Patients receive fluorouracil IV on days 1, 8, 15, and 22, followed by gemcitabine IV over 30 minutes on days 29, 36, 43, and 50. Interferon alfa is administered subcutaneously 3 times weekly beginning on day 1. Beginning on day 2, interleukin-2 is administered subcutaneously 3 times weekly for the first 4 weeks of the treatment course. Treatment is repeated every 8 weeks for up to 4 courses in the absence of unacceptable toxic effects and disease progression. Following chemobiotherapy, maintenance therapy is administered to patients with stable or responding disease. Patients receive subcutaneous interferon alfa 3 times weekly at the maximum tolerated dose until disease progression or for a maximum of 1 year. A quality of life assessment is completed weekly. Patients are followed until death.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18-24 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 70 years
- 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 |
|---|---|---|
| aldesleukin | Biological | – |
| recombinant interferon alfa | Biological | – |
| fluorouracil | Drug | – |
| gemcitabine hydrochloride | 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 6 Nov 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.
Gamini S. Soori, MD, FACP, FRCP, MBA study chair
Cancer Biotherapy Research Group
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 aldesleukin, recombinant interferon alfa and fluorouracil in people with Kidney Cancer, run by Cancer Biotherapy Research Group 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 6 Nov 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.
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 6 Nov 2013.