Combination Therapy With 5-Fluorouracil, Interferon-an Interleukin-2, & Thalidomide for Metastatic, Advanced or Recurrent Renal Cell Carcinoma

September 23, 2011 updated by: New Mexico Cancer Care Alliance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: 5-Flourouracil, Interferon-a, IL-2 and Thalidomide

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - University of New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - Lovelace Sandia Health Systems Dept of Hematology
  - Santa Fe, New Mexico, United States
    - New Mexico Cancer Care Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate a therapy combining the established FUNIL regimen with Thalidomide. Time Frame: Treatment stopped if there is disease progression or toxicity	Treatment stopped if there is disease progression or toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Mexico Cancer Care Alliance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria