Interferon Alfa in Treating Patients With Advanced Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003542
First received: November 1, 1999
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Biological: pegylated interferon alfa
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 58
Study Start Date: May 1998
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003542

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003542     History of Changes
Other Study ID Numbers: 98-052, CDR0000066596, ROCHE-NO15753C, UCLA-9903045, NCI-G98-1475
Study First Received: November 1, 1999
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014