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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert J. Motzer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-052

NCT ID:

NCT00003542

Start Date:

May 1998

Completion Date:

April 2004

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781