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Interleukin-12 Plus Interleukin-2 in Treating Patients With Advanced Solid Tumors
This study has been completed.
First Received: May 2, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005604
  Purpose

RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.

Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining the two drugs may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-12 plus interleukin-2 in treating patients who have advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: aldesleukin
Biological: recombinant interleukin-12
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Aldesleukin Interleukin-12
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial of Twice Weekly IV IL-12 Plus Low-Dose Subcutaneous IL-2 in Patients With Advanced Malignancies

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of low-dose interleukin-2 administered with interleukin-12 in patients with advanced solid malignancies.
  • Determine the toxicity of this regimen in these patients.
  • Determine the anti-tumor effects of this regimen in these patients.
  • Determine the impact of interleukin-2 on the magnitude and duration of in vivo immune activation induced by interleukin-12 in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive interleukin-12 (IL-12) IV on days 1 and 4 for 6 weeks. Beginning on day 4 of the third week, patients receive interleukin-2 (IL-2) subcutaneously 1 hour before and 20 hours after each dose of IL-12. On subsequent courses, IL-2 and IL-12 are administered on days 1 and 4 of each week.

Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease response may continue treatment until complete response or disease progression.

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

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic or unresectable solid tumor that is unlikely to respond to existing therapy or for which no curative therapy exists
  • Measurable or evaluable disease which is clearly progressive
  • No hematologic malignancies
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1
  • Karnofsky 80-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC greater than 4,000/mm3
  • Absolute neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT and SGPT less than 2 times normal
  • No active (clinical or subclinical) hepatitis B or C infection

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No congestive heart failure
  • No symptoms of coronary artery disease
  • No serious cardiac arrhythmias
  • No evidence of prior myocardial infarction

Other:

  • No active infection requiring antibiotic therapy
  • No medical condition requiring the use of corticosteroids during study
  • No autoimmune or rheumatologic disease
  • No seizure disorders
  • No significant medical disease that would preclude study
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • At least 6 months since prior interleukin-2
  • At least 12 months since prior interleukin-12
  • No more than 2 prior biological response modifier treatment regimens

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for prior nitrosoureas or mitomycin) and recovered
  • No more than 2 prior chemotherapy regimens
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy and recovered
  • No concurrent hormonal therapy (including steroids and hormone replacement therapy)

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • No prior organ allografts

Other:

  • At least 2 weeks since prior IV antibiotics
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005604

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Study Chair: Michael B. Atkins, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067723, BIH-99-1332, NCI-65
Study First Received: May 2, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005604     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Anti-HIV Agents
Interleukin-12
Aldesleukin
Anti-Retroviral Agents
Immunologic Factors
Interleukin-2
Adjuvants, Immunologic
Antiviral Agents
Angiogenesis Inhibitors

Additional relevant MeSH terms:
Anti-Infective Agents
Interleukin-12
Anti-HIV Agents
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Aldesleukin
Anti-Retroviral Agents
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009