Interferon Alfa in Treating Patients With Advanced Kidney Cancer

June 24, 2013 updated by: Memorial Sloan Kettering Cancer Center

Phase I/II Study of Subcutaneous Administration of Pegylated-Interferon Alpha-2A (RO 25-8310) in Previously Untreated Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa in treating patients with advanced kidney cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of pegylated-interferon alfa-2a in patients with advanced or metastatic renal cell carcinoma. II. Evaluate the safety profile of the MTD in this patient population. III. Determine the objective response rate, time to response, duration of response, time to progression, and survival rate in this patient population.

OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive pegylated-interferon alfa-2a (PEG-IFN) subcutaneously once a week for 24 weeks. Dose escalation of PEG-IFN continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. After the MTD of PEG-IFN is determined, additional patients are treated at this dose level. These patients may continue treatment after the first 24 weeks for up to 1 year, in the absence of disease progression. Patients are followed for 4 weeks.

PROJECTED ACCRUAL: A total of 46-58 patients will be accrued for this study within 9 months.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced or metastatic renal cell carcinoma Bidimensionally measurable lesions that have not been irradiated Minimum indicator lesion size: Liver, soft tissue, or other masses - one diameter at least 20 mm (evaluable only radiographically) Lung - one diameter at least 10 mm by x-ray or CT scan Skin lesions and lymph nodes - one diameter at least 10 mm by clinical measurement No clinical or radiologic evidence of CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (red cell transfusions allowed) Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN) (except for patients with Gilbert's syndrome) ALT and/or AST no greater than 2.5 times ULN (no greater than 4 times ULN with liver metastases) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 4 times ULN with liver metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history of severe cardiac disease: New York Heart Association class II (if not due to cancer), III, or IV Myocardial infarction within the past 6 months Ventricular tachyarrhythmias requiring ongoing treatment Unstable angina Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior or concurrent malignancy except basal cell carcinoma of the skin, carcinoma in situ of the cervix, or any other malignancy from which the patient has been disease free for at least 2 years No history of medically significant psychiatric disease, especially depression No history or evidence of retinopathy No seizure disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent immunotherapy, biologic response modifiers, cytokines, monoclonal antibodies, antitumor vaccines, or any other systemic therapy Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: No prior or concurrent hormone therapy Hormone replacement after adrenalectomy is allowed Radiotherapy: Prior radiotherapy allowed No concurrent radiotherapy Surgery: Prior nephrectomy allowed Other: No other concurrent investigational drugs No concurrent anticonvulsant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 3, 2004

First Posted (Estimate)

August 4, 2004

Study Record Updates

Last Update Posted (Estimate)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-052
  • CDR0000066596 (Registry Identifier: PDQ (Physician Data Query))
  • ROCHE-NO15753C
  • UCLA-9903045
  • NCI-G98-1475

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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