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Kidney CancerPhase 3NCT00416429

Medroxyprogesterone or Interferon and/or Aldesleukin in Treating Patients With Metastatic Kidney Cancer

A Phase 3 study testing aldesleukin, recombinant interferon alpha-2a and medroxyprogesterone in people with Kidney Cancer, run by Centre Leon Berard.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Medroxyprogesterone may help shrink or slow the growth of kidney cancer. Interferon may interfere with the growth of tumor cells. Aldesleukin may stimulate white blood cells to kill tumor cells. 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, recombinant interferon alpha-2a and medroxyprogesterone
How many people
456 participants
Where
No sites listed yet
Study dates
Start not givento Feb 2005
Phase
Phase 3
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 metastatic renal cell adenocarcinoma, meeting 1 of the following criteria:
  • More than 1 metastatic site and good performance status (Karnofsky score 80-100%)
  • Sole metastatic site with Karnofsky score = 80%
  • Karnofsky 90% or 100% not eligible
  • No combination of several metastatic sites and liver metastases and a time interval from primary tumor to metastases of < 1 year
  • Nonmeasurable disease and/or few numbers of lesions must be confirmed histologically and as progressive disease
  • The following metastases are allowed:
  • Lung with or without mediastinum lymph nodes
  • Bone
  • Pleura (solid or liquid with positive cytology)
  • Thoracic lymph nodes
  • Abdominal lymph nodes
  • Superficial lymph nodes
  • Liver
  • Subcutaneous skin/tissue
  • Contralateral kidney
  • Nephrectomy site
  • Other organs
  • Prior metastases allowed provided the following criteria are met:
  • Evidence of progressive disease within the past 3 months
  • Metastases evaluated by noninvasive methods
  • No evidence of active brain metastases
  • Prior brain metastases allowed provided all of the following criteria are met:
  • Disease is stable
  • Reductive therapy (surgery or radiotherapy) completed at least 3 weeks prior to study entry
  • Metastases have not progressed (confirmed by CT scan or MRI)
  • No concurrent corticosteroids required

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • Creatinine < 1.8 mg/dL
  • Hematocrit ≥ 30%
  • WBC ≥ 4,000/mm^3
  • Platelet count ≥ 120,000/mm^3
  • Bilirubin normal
  • LVEF ≥ 50%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HIV positivity
  • No severe infection requiring antibiotic therapy
  • No chronic hepatitis
  • No severe lung, liver or kidney condition that would preclude study treatment
  • No hepatitis B surface antigen positivity
  • No severe neuropsychiatric condition or epilepsy
  • No serious thromboembolitic disorder
  • No severe cardiac dysfunction (e.g., congestive heart failure, uncontrolled hypertension, serious arrhythmia, or coronary disease)
  • No other prior or concurrent primary malignancies except for basal cell skin cancer or carcinoma in situ of the cervix
  • No geographical, psychological, or familial condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • More than 6 weeks since prior wide-field radiotherapy
  • No prior systemic chemotherapy
  • No prior organ transplantation
  • No prior cytokines
  • No concurrent hormonal therapy
  • No concurrent anticancer chemotherapy
  • No concurrent corticosteroids
  • No other concurrent immunotherapy
  • No other concurrent investigational agents or therapies

About this study

Official title: Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [PERCY QUATTRO]

RATIONALE: Medroxyprogesterone may help shrink or slow the growth of kidney cancer. Interferon may interfere with the growth of tumor cells. Aldesleukin may stimulate white blood cells to kill tumor cells. It is not yet known whether giving medroxyprogesterone, interferon, or aldesleukin alone is more effective than giving interferon together with aldesleukin in treating kidney cancer.

PURPOSE: This randomized phase III trial is studying medroxyprogesterone, interferon, or aldesleukin to see how well they work when given alone compared to interferon combined with aldesleukin in treating patients with metastatic kidney cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the overall survival of patients with metastatic renal cell adenocarcinoma treated with medroxyprogesterone vs recombinant interferon alfa-2a and/or aldesleukin.

Secondary

  • Determine the objective response rate (complete and partial) of patients treated with these regimens.
  • Determine the progression-free survival of patients treated with these regimens.
  • Determine the toxicity of these regimens in these patients.
  • Evaluate the quality of life of patients before and after induction treatment with these regimens (week 10).

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are randomized to 1 of 4 treatment arms.

  • Arm I (medroxyprogesterone): Patients receive oral medroxyprogesterone once daily for 12 weeks. Patients may receive a second 12-week course in the presence of responding or stable disease. Quality of life is assessed at baseline and at weeks 12 and 24.
  • Arm II (recombinant interferon alfa-2a): Patients receive recombinant interferon alfa-2a subcutaneously (SC) 3 times weekly for 12 weeks. Patients may receive a second 12-week course in the presence of responding or stable disease. Quality of life is assessed as in arm I.
  • Arm III (aldesleukin): Patients receive aldesleukin SC twice daily on days 1-5, 8, 9, 15, 16, 22, and 23 and once daily on days 10-12, 17-19, and 24-26. Courses repeat beginning in weeks 6, 13, and 20. Quality of life is assessed at baseline and at weeks 10 and 24.
  • Arm IV (recombinant interferon alfa-2a and aldesleukin): Patients receive recombinant interferon alfa-2a as in arm II and receive aldesleukin as in arm III. Quality of life is assessed as in arm III.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 456 patients will be accrued for this study.

Conditions
Kidney Cancer
Being tested
aldesleukin, recombinant interferon alpha-2a, medroxyprogesterone
Keywords
recurrent renal cell cancer, stage IV 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 alpha-2aBiological

  • medroxyprogesteroneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

Secondary outcomes (4)
  1. Objective response rate (complete and partial)

  2. Progression-free survival

  3. Toxicity

  4. Quality of life in week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2006 (estimated)
  2. Study completionFeb 2005

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
456 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00416429
Sponsor's protocol ID
CDR0000468571
Other IDs
LEONB-PERCY-QUATTRO, EU-20605, LEONB-ET99-058, ROCHE-LEONB-PERCY-QUATTRO, CHIRON-LEONB-PERCY-QUATTRO
Status last verified
Sep 2012
First submitted
27 Dec 2006
Last updated
26 Sep 2012
Results posted
No

Publications

  • Negrier S, Perol D, Ravaud A, Chevreau C, Bay JO, Delva R, Sevin E, Caty A, Escudier B; French Immunotherapy Intergroup. Medroxyprogesterone, interferon alfa-2a, interleukin 2, or combination of both cytokines in patients with metastatic renal carcinoma of intermediate prognosis: results of a randomized controlled trial. Cancer. 2007 Dec 1;110(11):2468-77. doi: 10.1002/cncr.23056.

    PubMed 17932908

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aldesleukin, recombinant interferon alpha-2a and medroxyprogesterone in people with Kidney Cancer, run by Centre Leon Berard.

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: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00416429, which also lists 1 linked publication.

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 26 Sep 2012.

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