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Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

This study has been completed.
Information provided by:
Memorial Sloan-Kettering Cancer Center Identifier:
First received: September 6, 2002
Last updated: June 4, 2013
Last verified: June 2013

September 6, 2002
June 4, 2013
April 2002
November 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00045370 on Archive Site
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Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Intravenous CCI-779 Given in Combination With Escalating Doses of Interferon-Alpha to Patients With Advanced Renal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. Combining biological therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological therapy in treating patients who have locally advanced or metastatic kidney cancer.


  • Determine the maximum tolerated dose of CCI-779 in combination with interferon alfa in patients with locally advanced or metastatic renal cell cancer.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine, preliminarily, any antitumor activity of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive interferon alfa (IFN-A) subcutaneously 3 times a week. Beginning on week 2, patients also receive CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of at least 6 patients receive escalating doses of CCI-779 and then IFN-A until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 additional patients are treated at that dose level.

Patients are followed at 30 days.

PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.

Phase 1
Primary Purpose: Treatment
Kidney Cancer
  • Biological: recombinant interferon alfa
  • Drug: temsirolimus
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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November 2003
November 2003   (final data collection date for primary outcome measure)


  • Histologically confirmed locally advanced or metastatic renal cell cancer

    • Progressive disease after treatment with 0-2 courses of immunotherapy, chemotherapy, or other systemic therapy for advanced disease
  • Measurable or evaluable disease
  • No concurrent CNS metastases

    • Prior CNS metastases allowed if no residual disease by MRI



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 3 months


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)


  • Creatinine less than 2 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • No unstable angina
  • No myocardial infarction within the past 6 months


  • Cholesterol no greater than 350 mg/dL
  • Triglycerides no greater than 400 mg/dL
  • HIV negative
  • Not immunocompromised
  • No active autoimmune disorder
  • No active infection requiring antibiotic therapy
  • No other serious concurrent illness
  • No known hypersensitivity to components of CCI-779, interferon alfa, diphenhydramine hydrochloride, or both acetaminophen and nonsteroidal anti- inflammatory drugs
  • No other major illness that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation


Biologic therapy

  • See Disease Characteristics
  • At least 3 weeks since prior immunotherapy
  • No prior interferon alfa
  • No other concurrent immunotherapy
  • No prophylactic growth factors
  • Concurrent epoetin alfa allowed


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • No prior CCI-779
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy for malignancy (megestrol for appetite loss allowed)
  • Concurrent inhaled or replacement steroids allowed


  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • At least 3 weeks since prior surgery


  • See Disease Characteristics
  • At least 3 weeks since prior immunosuppressive agents
  • At least 4 weeks since prior investigational agents
  • No other concurrent investigational agents
  • No concurrent immunosuppressive therapy
  • No concurrent anticonvulsants known to be cytochrome P450 inducers, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide
  • No concurrent maintenance therapy for life-threatening ventricular arrhythmia
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
02-023, CDR0000256468, NCI-G02-2104, W-AR-3066K1-124-US, WYETH-C-C0125-32
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP