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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.

Phase 1/Phase 2
Not Enrolling
Kidney, Cancer

Thank you

Trial Information

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.

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

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate a therapy combining the established FUNIL regimen with Thalidomide.

Outcome Time Frame:

Treatment stopped if there is disease progression or toxicity

Safety Issue:


Principal Investigator

Fa-Chyi Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:




Start Date:

September 2000

Completion Date:

August 2005

Related Keywords:

  • Kidney
  • Cancer
  • Combination Therapy
  • 5-Fluorouracil
  • Interferon-a Interleukin-2
  • Thalidomide
  • Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell



New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
University of New MexicoAlbuquerque, New Mexico  87131
Lovelace Sandia Health Systems Dept of HematologyAlbuquerque, New Mexico  87108