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Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen


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

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Trial Information

Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen


OBJECTIVES:

Primary

- Determine the best response in patients with advanced or unresectable renal cell cancer
treated with lenalidomide (CC-5013).

- Determine the time to disease progression in patients treated with this drug.

Secondary

- Determine the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma (RCC)

- Advanced or unresectable disease

- At least 1 measurable lesion

- No active brain metastases

- Prior brain metastases allowed provided patient has been treated with
radiotherapy or surgery AND remains asymptomatic for ≥ 6 months

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 mg/dL

- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases
are present)

- No hepatitis A, B, or C infection

Renal

- Creatinine ≤ 2.0 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No known hypersensitivity to thalidomide

- No other serious medical condition, laboratory abnormality, or psychiatric illness
that would preclude giving informed consent

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix or breast, localized
prostate cancer, or superficial bladder cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No more than 1 prior systemic immunotherapy regimen for RCC

- No prior lenalidomide (CC-5013)

- No prior or concurrent thalidomide

Chemotherapy

- No more than 1 prior systemic chemotherapy regimen for RCC

Endocrine therapy

- No more than 1 prior systemic hormonal therapy regimen for RCC

Radiotherapy

- See Disease Characteristics

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

- At least 4 weeks since prior surgery and recovered

Other

- No more than 1 other prior systemic therapy regimen for RCC

- No other concurrent anticancer therapies

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy (complete and partial response)

Safety Issue:

No

Principal Investigator

Gnanamba V. Kondagunta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

04-014

NCT ID:

NCT00096525

Start Date:

July 2004

Completion Date:

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