- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00080977
High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells.
PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.
Studieöversikt
Detaljerad beskrivning
OBJECTIVES:
- Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2.
- Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a pilot study.
Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1).
Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity.
Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Studietyp
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
North Carolina
-
Charlotte, North Carolina, Förenta staterna, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
- Metastatic disease
- No pure papillary or sarcomatoid variants
- Measurable disease
Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2
- Documented disease progression
- No estimated hepatic replacement by tumor > 25% by CT scan or MRI
- No tumor involving the CNS or a major nerve
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 80-100%
Life expectancy
- More than 3 months
Hematopoietic
- Platelet count ≥ 80,000/mm^3
- No sites of ongoing bleeding
Hepatic
- See Disease Characteristics
- Bilirubin ≤ 1.4 mg/dL
- AST and ALT ≤ 3 times normal
- PT or PTT INR ≤ 1.2
- Hepatitis B surface antigen negative
- Hepatitis C virus negative
- No coagulation disorders
Renal
- Creatinine ≤ 1.6 mg/dL
Cardiovascular
- No ongoing ischemia*
- No cardiac dysfunction*
- No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram
Pulmonary
- FEV_1 ≤ 65% of predicted*
- Vital capacity ≤ 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph
Other
- HIV negative
- No AIDS
- No systemic infections
- No other malignancy except carcinoma in situ
- No psychiatric illness that would preclude study participation or compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- No concurrent steroids
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 28 days since other prior treatment for renal cell cancer
- No concurrent immunosuppressive agents
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
Samarbetspartners och utredare
Utredare
- Studiestol: Richard L. White, MD, Blumenthal Cancer Center at Carolinas Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urologiska neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Njursjukdomar
- Urologiska sjukdomar
- Adenocarcinom
- Carcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i njurarna
- Karcinom, njurcell
- Anti-infektionsmedel
- Antivirala medel
- Anti-HIV-medel
- Antiretrovirala medel
- Antineoplastiska medel
- Aldesleukin
Andra studie-ID-nummer
- CDR0000357581
- CMC-10-01-01AH
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