Kidney CancerPhase 2NCT00002846
Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
A Phase 2 study testing aldesleukin and conventional surgery in people with Kidney Cancer, run by Blumenthal Cancer Center at Carolinas Medical Center at 1 site in United States.
Trial summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer. 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?
- aldesleukin and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1995to 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 (RCC) that is metastatic or recurrent
- No central nervous system or major nerve involvement
- No more than 25% estimated hepatic replacement by tumor on CT or MRI
- Measurable disease required
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 80%-100%
Life expectancy:
- Greater than 3 months
Hematopoietic:
- Platelet count at least 80,000/mm3
Hepatic:
- Bilirubin normal
- AST and ALT no greater than 3 times normal
Renal:
- Creatinine normal
Cardiovascular:
- Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG)
Pulmonary:
- FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray)
Other:
- No sites of ongoing bleeding
- No HIV antibody or AIDS
- No hepatitis B antigen
- No systemic infection
- No requirement for steroids
- No psychiatric disease that precludes informed consent or safe administration of immunotherapy
- No second malignancy except:
- Basal cell carcinoma
- In situ cervical cancer
- Other cancer provided all evaluable lesions are documented RCC
- No pregnant or nursing women
- Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior interleukin-2 therapy
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 28 days since therapy for RCC
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
About this study
Official title: TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.
PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.
Read the detailed description
OBJECTIVES:
- Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2.
- Assess the toxicity associated with this treatment.
OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited.
Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- aldesleukin, conventional surgery
- 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
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1995
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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blumenthal Cancer Center at Carolinas Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Richard L. White, MD, Study chair, Blumenthal Cancer Center at Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002846
- Sponsor's protocol ID
- CDR0000065085
- Other IDs
- CMC-09-95-15B, NCI-V96-1038
- Status last verified
- Dec 2003
- First submitted
- 1 Nov 1999
- 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
- TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2
- ClinicalTrials.gov ID
- NCT00002846
- Acronym / sponsor ID
- CDR0000065085
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Blumenthal Cancer Center at Carolinas Medical CenterUniversity, hospital or other
- Study start
- Sep 1995
- First posted
- 27 Jan 2003 (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: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.
PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.
Detailed description
OBJECTIVES:
- Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2.
- Assess the toxicity associated with this treatment.
OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited.
Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 14 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 |
|---|---|---|
| aldesleukin | Biological | – |
| conventional surgery | Procedure or surgery | – |
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 19 Dec 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.
Richard L. White, MD study chair
Blumenthal Cancer Center at Carolinas 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 2 study testing aldesleukin and conventional surgery in people with Kidney Cancer, run by Blumenthal Cancer Center at Carolinas 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 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 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?
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 19 Dec 2013.