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

NCT00416429 | Completed Phase 3

• 6 other identifiers: CDR0000468571LEONB-PERCY-QUATTROEU-20605LEONB-ET99-058ROCHE-LEONB-PERCY-QUATTROCHIRON-LEONB-PERCY-QUATTRO
• Study Type: interventional
• Target: 456
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (4)

• Objective response rate (complete and partial)

• Progression-free survival

• Toxicity

• Quality of life in week 10

Interventions

aldesleukin BIOLOGICAL

recombinant interferon alpha-2a BIOLOGICAL

medroxyprogesterone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Leon Berard: lead

Related Publications (1)

• 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.

  PMID: 17932908 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

aldesleukin; Interferon alpha-2; Medroxyprogesterone

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sylvie Negrier, MD

  Centre Leon Berard

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Completion: February 1, 2005
• Last Updated: September 26, 2012

Record last verified: 2012-09