search
Back to results

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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
temsirolimus
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic 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) Renal Creatinine less than 2 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular No unstable angina No myocardial infarction within the past 6 months Other 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 PRIOR CONCURRENT THERAPY: 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 Chemotherapy 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 Radiotherapy At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery At least 3 weeks since prior surgery Other 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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
June 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00045370
Brief Title
Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
temsirolimus

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic 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) Renal Creatinine less than 2 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular No unstable angina No myocardial infarction within the past 6 months Other 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 PRIOR CONCURRENT THERAPY: 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 Chemotherapy 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 Radiotherapy At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery At least 3 weeks since prior surgery Other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Motzer, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs