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Interleukin-2 and Interleukin-12 in Treating Patients With Refractory or Advanced Solid Tumors
This study is currently recruiting participants.
Study NCT00020163   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: September 18, 2009   History of Changes

July 11, 2001
September 18, 2009
June 2000
 
 
 
Complete list of historical versions of study NCT00020163 on ClinicalTrials.gov Archive Site
 
 
 
Interleukin-2 and Interleukin-12 in Treating Patients With Refractory or Advanced Solid Tumors
A Phase I Investigation of IL-12/Pulse IL-2 in Adults With Advanced Solid Tumors

RATIONALE: Interleukin-2 may stimulate a person's lymphocytes to kill solid tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill solid tumor cells. Combining interleukin-2 with interleukin-12 may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 and interleukin-12 in treating patients with refractory or advanced solid tumors.

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxic effects of interleukin-12 and interleukin-2 in patients with refractory or advanced solid tumors.
  • Assess the pharmacokinetics of this treatment regimen in these patients.
  • Assess the antitumor effect of this treatment regimen in this patient population.
  • Determine the immunomodulatory activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

  • Part I: Patients receive interleukin-2 IV over 15 minutes every 8 hours on days 1 and 9 and interleukin-12 IV on days 2, 4, 6, 10, 12, and 14. Treatment continues every 35 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interleukin-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Part II: Once the MTD is determined, an additional 10 patients are treated at the MTD.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 24-34 patients will be accrued for part I and total of 10 patients will be accrued part II of the study within approximately 2 years.

Phase I
Interventional
Treatment
  • Breast Cancer
  • Kidney Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Sarcoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: aldesleukin
  • Biological: recombinant interleukin-12
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed refractory or advanced nonhematologic malignancy (e.g., breast, lung, or renal cell cancer or sarcoma) for which no curative therapy exists

    • Patients with renal cell cancer must have specifically refused or been ineligible to receive prior interleukin-2
  • Evaluable disease
  • No clinically significant pleural effusion
  • No prior or concurrent brain metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • No history of congenital or acquired coagulation disorder

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • Transaminases less than 2.5 times upper limit of normal
  • Hepatitis B negative

Renal:

  • Creatinine less than 2.0 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No history of coronary artery disease, angina, or myocardial infarction
  • Normal stress thallium testing if over the age of 50

Pulmonary:

  • Normal pulmonary function, defined as DLCO more than 60% predicted and FEV1 more than 70% predicted

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 2 months after study
  • HIV negative
  • No concurrent acute infection
  • No other systemic illness (not critically ill or medically unstable)
  • No malignant hyperthermia
  • No prior or concurrent autoimmune disease
  • No history of ongoing or intermittent bowel obstruction

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior immunotherapy, filgrastim (G-CSF) or sargramostim (GM-CSF), interferons or interleukins, epoetin alfa, or intravenous immunoglobulins
  • No prior therapy with IL-2
  • No prior interleukin-12
  • No prior bone marrow or stem cell transplantation
  • No other concurrent cytokines or potential immunomodulators

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior systemic corticosteroids, growth hormone treatment, or myelosuppressive hormonal therapy
  • No concurrent hormonal therapy (including oral contraceptives) except systemic corticosteroids in the case of life-threatening complications such as Pneumocystis carinii pneumonia

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • Concurrent radiotherapy allowed if it is not necessitated by disease progression

Surgery:

  • Not specified

Other:

  • At least 4 weeks since prior investigational agents
  • At least 4 weeks since prior tretinoin
  • No other concurrent investigational agents
  • No concurrent tretinoin
Both
18 Years and older
No
 
United States
 
NCT00020163
 
CDR0000067889, NCI-00-C-0121, NCI-41
National Cancer Institute (NCI)
 
Study Chair: John E. Janik, MD NCI - Metabolism Branch;MET
National Cancer Institute (NCI)
February 2007

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