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A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer


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

Thank you

Trial Information

A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer


OBJECTIVES:

- Determine the activity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal
antibody in patients with metastatic clear cell renal cancer who are refractory to or
ineligible for interleukin-2.

- Determine the impact of this drug on T-cell number and phenotype in these patients.

OUTLINE: This is an open-label study.

Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV
over 90 minutes once every 3 weeks for up to 4 courses in the absence of disease progression
or unacceptable toxicity. Patients with an ongoing partial response may receive additional
courses of therapy.

Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 2 years, and
then annually until disease progression.

PROJECTED ACCRUAL: A total of 21-103 patients will be accrued for this study within 2-4
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV clear cell renal carcinoma

- At least 1 site of measurable disease

- Meeting criteria for 1 of the following:

- Disease progression after prior interleukin-2 (IL-2)

- Ineligible for standard high-dose IV IL-2 due to comorbid medical conditions

- Minimal disease (lesions ≤ 3 cm that do not pose risk to organ function) such
that participation in this study is not likely to compromise the patient's
opportunity to receive future high-dose IL-2

- Indolent disease (defined as an increase in tumor size of < 50% within the past
6 months) such that participation in this study is not likely to compromise the
patient's opportunity to receive future high-dose IL-2

- No true papillary, medullary, chromophobe, collecting duct, or oncocytic renal
cancer

PATIENT CHARACTERISTICS:

Age

- 16 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 3 months

Hematopoietic

- WBC ≥ 2,500/mm^3

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

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL

- Hematocrit ≥ 30%

Hepatic

- AST ≤ 3 times upper limit of normal (ULN)

- Bilirubin ≤ ULN (< 3.0 mg/dL for patients with Gilbert's syndrome)

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative

Renal

- Creatinine < 2.0 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No other malignancy except adequately treated basal cell or squamous cell skin
cancer, superficial bladder cancer, or carcinoma in situ of the cervix or any other
cancer from which the patient has been disease free for at least 5 years

- No autoimmune disease (including uveitis and autoimmune inflammatory eye disease)

- No active uncontrolled infection

- No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

- At least 3 weeks since prior immunotherapy for renal cancer

Chemotherapy

- At least 3 weeks since prior chemotherapy for renal cancer

- No concurrent chemotherapy

Endocrine therapy

- At least 3 weeks since prior hormonal therapy for renal cancer

- More than 4 weeks since prior corticosteroids

- No concurrent systemic or topical corticosteroids

Radiotherapy

- At least 3 weeks since prior radiotherapy for renal cancer

Surgery

- Not specified

Other

- Recovered from prior therapy

- At least 3 weeks since other prior therapy for renal cancer

- No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

James C. Yang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

030094

NCT ID:

NCT00057889

Start Date:

February 2003

Completion Date:

February 2008

Related Keywords:

  • Kidney Cancer
  • clear cell renal cell carcinoma
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182