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Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
This study has been completed.
Study NCT00032188   Information provided by National Cancer Institute (NCI)
First Received: March 8, 2002   Last Updated: February 6, 2009   History of Changes

March 8, 2002
February 6, 2009
February 2002
June 2006   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00032188 on ClinicalTrials.gov Archive Site
 
 
 
Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
A Randomized Phase II Study Of Interluekin-2 In Combination With Three Different Doses Of Bryostatin In Patients With Renal Cell Carcinoma

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bryostatin 1 with interleukin-2 may cause a stronger immune response and kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combining interleukin-2 and bryostatin 1 in treating patients who have advanced kidney cancer.

OBJECTIVES:

  • Determine the objective response rate in patients with advanced renal cell carcinoma treated with interleukin-2 (IL-2) and bryostatin 1.
  • Compare the toxicity of 3 different doses of bryostatin 1 given in combination with a fixed dose of IL-2 in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three dose levels of bryostatin 1.

Patients receive interleukin-2 (IL-2) subcutaneously on days 1-4, 8-11, and 15-18. For the second and subsequent courses of IL-2, patients also receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 3 additional courses of therapy.

An additional cohort of patients receives treatment as above at a higher dose to evaluate toxicity.

Patients are followed for 1 year.

PROJECTED ACCRUAL: A total of 24-65 patients (8-16 per bryostatin 1 dose level) will be accrued for this study within 14-27 months.

Phase II
Interventional
Treatment, Randomized, Active Control
Kidney Cancer
  • Biological: aldesleukin
  • Drug: bryostatin 1
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
June 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed renal cell carcinoma

    • Recurrent or refractory advanced disease OR
    • Newly diagnosed disease with no appropriate standard therapy available
  • Measurable disease
  • No active CNS metastases

    • Single prior CNS metastasis allowed if all of the following are true:

      • Previously resected and irradiated
      • No evidence of progressive CNS disease for at least 8 weeks after completion of therapy
      • No requirement for steroids or anti-seizure medications

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and for 3 months after study for male patients
  • No concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior interleukin-2

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics
  • Prior radiotherapy to less than 50% of bone marrow allowed
  • At least 4 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032188
 
CDR0000069267, UCCRC-11367, UCCRC-NCI-5550, NCI-5550
University of Chicago
National Cancer Institute (NCI)
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
National Cancer Institute (NCI)
October 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP