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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00045370
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 5, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: recombinant interferon alfa Drug: temsirolimus Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2002
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
Drug Information available for: Interferon

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00045370

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Robert J. Motzer, MD Memorial Sloan Kettering Cancer Center

Layout table for additonal information Identifier: NCT00045370    
Other Study ID Numbers: 02-023
CDR0000256468 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents