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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: aldesleukin
* Biological: recombinant interferon alpha-2a
* Drug: medroxyprogesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: recombinant interferon alpha-2a|nan|
|Drug: medroxyprogesterone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (complete and partial) |  |  | 
| Progression-free survival |  |  | 
| Toxicity |  |  | 
| Quality of life in week 10 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent renal cell cancer, stage IV renal cell cancer