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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


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

Thank you

Trial Information

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


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.

Inclusion 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

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:

02-023

NCT ID:

NCT00045370

Start Date:

April 2002

Completion Date:

November 2003

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell 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