KidneyPhase 1/2NCT00277017
Combination Therapy With 5-Fluorouracil, Interferon-an Interleukin-2, & Thalidomide for Metastatic, Advanced or Recurrent Renal Cell Carcinoma
A Phase 1/2 study testing 5-Flourouracil, Interferon-a, IL-2 and Thalidomide in people with Kidney and Cancer, run by New Mexico Cancer Research Alliance at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate a therapy combining the established FUNIL regimen with Thalidomide. We want to see how well the therapy works, if it can be easily done, and how well the body handles the treatment. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- 5-Flourouracil, Interferon-a, IL-2 and Thalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2000to Aug 2005
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients must have histologically proven renal cell carcinoma which is metastatic, non-resectable and/or recurrent.
- Patients must have bidimensionally measurable disease as defined in Section 10.1a documented within 28 days prior to registration. X-rays, scans, or physical exam of all non-measurable disease must be completed within 42 days prior to registration.
- Prestudy chest x-ray must be done within 42 days prior to registration.
- Prior treatment with drugs included in this protocol is permitted if such prior treatment occurred more than 6 months previous or if patient is currently exhibiting minor, mixed or partial response to any of these drugs. Prior treatment with other drugs is allowed as long as therapy was discontinued at least one month previously.
- Prior radiation therapy (to less than 25% of the bone marrow only, see section 19.2), or surgery are allowed. At least 4 weeks must have elapsed since the completion of radiation therapy, and there must be measurable disease outside the radiation fields. At least 3 weeks must have elapsed since completion of surgery.
- Patients must have had an EKG performed within 28 days prior to registration.
- Patients must have a Southwest Oncology Group performance status of 0-2 as defined in Section 10.4.
Who cannot join
- Patients must not be receiving or planning to receive concomitant biologic therapy, radiation therapy, hormonal therapy, or other chemotherapy while on this protocol (including G/GM-CSF).
- Patients with currently untreated brain metastases or brain metastases on current therapy are not eligible. Patients with prior brain metastases S/P radiation and/or surgery, and with stable response, confirmed by MRI, off corticosteroids may be eligible. Brain MRI within 28 days of treatment and consultation with the Study Coordinator is required for such patients.
- Pregnant or nursing women may not participate. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Patients with other serious illnesses, serious active infections requiring treatment with antibiotics, those requiring ongoing therapy with other investigational drugs or those receiving or expected to require corticosteroids are not permitted.
- Patients with known AIDS or HIV-1 associated complex or known to be HIV antibody seropositive are not eligible.
- In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day.
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- Patients must be informed of the investigational nature of this study and give written in-formed consent in accordance with institutional and federal guidelines.
- Patients must be registered with the UNM Cancer Center Protocol Office. All records and flow sheets must be sent to this office.
- Active substance abuse can lead to unexpected and dangerous drug interactions and toxicities and impair compliance; therefore, this condition is an exclusion to registration or continuation on this study. Patients with a history of substance abuse must have blood or urine testing prior to registration on protocol. Psychosocial screening by the clinic psychologist or social worker is also suggested but not required. Patients found to be actively engaged in substance abuse while on protocol may be discontinued from protocol treatment at the direction of their physician and/or the study coordinator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lovelace Sandia Health Systems Dept of Hematology
Albuquerque, New Mexico, 87108
University of New Mexico
Albuquerque, New Mexico, 87131
New Mexico Cancer Care Associates
Santa Fe, New Mexico
About this study
Official title: A Phase I/II Trial of Combination Therapy With 5-Fluorouracil, Interferon-an Interleukin-2, and Thalidomide for Metastatic, Advanced or Recurrent Renal Cell Carcinoma.
The purpose of this study is to evaluate a therapy combining the established FUNIL regimen with Thalidomide. We want to see how well the therapy works, if it can be easily done, and how well the body handles the treatment. We also wish to see if the addition of Thalidomide will increase the effectiveness of the already established treatment regimen.
Read the detailed description
Eligible patients who agree to take part in the study will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a maximum of 1200mg/day. This will be taken in combination with:
5-fluorouracil, given by continuous IV infusion over 24 hours (Day 1) every week for 4 weeks.
Interferon-α, given subcutaneously on Day 1, 3 and 5 of every week for 4 weeks.
Interleukin-2, given by continuous IV infusion Days 2-5, every week for 4 weeks.
Treatment will be followed by 2 weeks of rest then repeated.
- Being tested
- 5-Flourouracil, Interferon-a, IL-2 and Thalidomide
- Keywords
- Combination Therapy, 5-Fluorouracil, Interferon-a Interleukin-2, Thalidomide, Renal Cell Carcinoma
- Medical subject headings
- Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Flourouracil, Interferon-a, IL-2 and ThalidomideDrug
Also called Flourouracil
Patients will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a max of 1200mg/day. This will be taken in combination with:5-fluorouracil, given by continuous IV infusion over 24 hours (Day 1) every week for 4 weeks.
Interferon-α, given subcutaneously on Day 1, 3 and 5 of every week for 4 weeks. Interleukin-2, given by continuous IV infusion Days 2-5, every week for 4 weeks.
Treatment will be followed by 2 weeks of rest then repeated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate a therapy combining the established FUNIL regimen with Thalidomide.
Measured: Treatment stopped if there is disease progression or toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startSep 2000
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KidneyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fa-Chyi Lee, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277017
- Sponsor's protocol ID
- 1500C
- Status last verified
- Dec 2009
- First submitted
- 11 Jan 2006
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Combination Therapy With 5-Fluorouracil, Interferon-an Interleukin-2, and Thalidomide for Metastatic, Advanced or Recurrent Renal Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT00277017
- Acronym / sponsor ID
- 1500C
- Keywords
- Combination Therapy, 5-Fluorouracil, Interferon-a Interleukin-2, Thalidomide, Renal Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Sep 2000
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 13 Jan 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.
The purpose of this study is to evaluate a therapy combining the established FUNIL regimen with Thalidomide. We want to see how well the therapy works, if it can be easily done, and how well the body handles the treatment. We also wish to see if the addition of Thalidomide will increase the effectiveness of the already established treatment regimen.
Detailed description
Eligible patients who agree to take part in the study will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a maximum of 1200mg/day. This will be taken in combination with:
5-fluorouracil, given by continuous IV infusion over 24 hours (Day 1) every week for 4 weeks.
Interferon-α, given subcutaneously on Day 1, 3 and 5 of every week for 4 weeks.
Interleukin-2, given by continuous IV infusion Days 2-5, every week for 4 weeks.
Treatment will be followed by 2 weeks of rest then repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- All patients must have histologically proven renal cell carcinoma which is metastatic, non-resectable and/or recurrent.
- Patients must have bidimensionally measurable disease as defined in Section 10.1a documented within 28 days prior to registration. X-rays, scans, or physical exam of all non-measurable disease must be completed within 42 days prior to registration.
- Prestudy chest x-ray must be done within 42 days prior to registration.
- Prior treatment with drugs included in this protocol is permitted if such prior treatment occurred more than 6 months previous or if patient is currently exhibiting minor, mixed or partial response to any of these drugs. Prior treatment with other drugs is allowed as long as therapy was discontinued at least one month previously.
- Prior radiation therapy (to less than 25% of the bone marrow only, see section 19.2), or surgery are allowed. At least 4 weeks must have elapsed since the completion of radiation therapy, and there must be measurable disease outside the radiation fields. At least 3 weeks must have elapsed since completion of surgery.
Key exclusion criteria (9 listed)
- Patients must not be receiving or planning to receive concomitant biologic therapy, radiation therapy, hormonal therapy, or other chemotherapy while on this protocol (including G/GM-CSF).
- Patients with currently untreated brain metastases or brain metastases on current therapy are not eligible. Patients with prior brain metastases S/P radiation and/or surgery, and with stable response, confirmed by MRI, off corticosteroids may be eligible. Brain MRI within 28 days of treatment and consultation with the Study Coordinator is required for such patients.
- Pregnant or nursing women may not participate. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Patients with other serious illnesses, serious active infections requiring treatment with antibiotics, those requiring ongoing therapy with other investigational drugs or those receiving or expected to require corticosteroids are not permitted.
- Patients with known AIDS or HIV-1 associated complex or known to be HIV antibody seropositive are not eligible.
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 |
|---|---|---|
| 5-Flourouracil, Interferon-a, IL-2 and ThalidomideAlso: FlourouracilPatients will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a max of 1200mg/day. This will be taken in combination with:5-fluorouracil, given by continuous IV infusion over 24 hours (Day 1) every week for 4 weeks. Interferon-α, given subcutaneously on Day 1, 3 and 5 of every week for 4 weeks. Interleukin-2, given by continuous IV infusion Days 2-5, every week for 4 weeks. Treatment will be followed by 2 weeks of rest then repeated. | Drug | – |
Primary outcome
Evaluate a therapy combining the established FUNIL regimen with Thalidomide.
Time frame: Treatment stopped if there is disease progression or toxicity
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 27 Sep 2011.
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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.
Fa-Chyi Lee, MD principal investigator
University of New Mexico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 5-Flourouracil, Interferon-a, IL-2 and Thalidomide in people with Kidney and Cancer, run by New Mexico Cancer Research Alliance at 3 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?
The sponsor lists 7 inclusion and 9 exclusion criteria. 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 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
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?
Evaluate a therapy combining the established FUNIL regimen with Thalidomide. (time frame: Treatment stopped if there is disease progression or toxicity). 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 27 Sep 2011.