Interleukin-12 Plus Interleukin-2 in Treating Patients With Advanced Solid Tumors

NCT00005604 | Completed Phase 1

• 3 other identifiers: NCI-2013-00049BIDMC #99-1332CDR0000067723
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• MTD defined as the dose level that is just below the dose on which at least 2 of 6 patients developed a dose-limiting toxicity (DLT) as assessed by CTC version 2.0

  6 weeks

Study Arms (1)

Treatment (rhIl-12, IL-2)

EXPERIMENTAL

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.

Biological: recombinant interleukin-12; Biological: aldesleukin; Other: laboratory biomarker analysis

Interventions

recombinant interleukin-12 BIOLOGICAL

Given IV

Also known as: cytotoxic lymphocyte maturation factor, IL-12, interleukin-12, natural killer cell stimulatory factor, Ro 24-7472

Treatment (rhIl-12, IL-2)

aldesleukin BIOLOGICAL

Given SC

Also known as: IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

Treatment (rhIl-12, IL-2)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (rhIl-12, IL-2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically confirmed solid tumor malignancy which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with hematologic malignancies will be excluded
• Patients must have advanced measurable or evaluable disease which is clearly progressive
• Patients must be ambulatory with good performance status (ECOG PS 0 or 1; Karnofsky PS 100-80%) and have an anticipated survival of at least 3 months
• Women of child bearing potential must have a negative pregnancy test and will be expected to use proven contraceptive methods while on protocol therapy; women who are breast-feeding are excluded from this study
• WBC \> 4000/mm\^3
• ANC \> 1500/mm\^3
• Platelet count \> 100,000/mm\^3
• Bilirubin \< 1.5 mg/dl
• SGOT, SGPT \< 2 x normal
• Creatinine \< 1.5 mg/dl or calculated creatinine clearance \>= 60 ml/min
• No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, or evidence of prior myocardial infarction on EKG
• No evidence of active infection which requires antibiotic therapy or history of treatment with IV antibiotics for a documented infection within 2 weeks of beginning treatment
• Patients must have recovered from the toxicity of prior therapy and have clearly progressive disease
• CHEMO, HORMONAL, AND RADIOTHERAPY There is a limit of two prior chemotherapy regimens which patients may have received; (patients who have received extensive prior cytotoxic therapy may no longer have adequate organ function and may not be eligible); at least 4 weeks must have elapsed from the end of previous chemotherapy, hormonal therapy, or radiotherapy (six weeks for nitrosoureas or mitomycin); concurrent chemotherapy, hormonal therapy or radiotherapy is not permitted; patients on steroids, including replacement therapy, will be excluded from the study
• BIOLOGICAL RESPONSE MODIFIERS No more than 2 prior BRM treatment regimens are permitted; prior immunotherapy should have been completed at least 4 weeks prior to beginning treatment on this protocol; prior therapy will IL-2 or rhIL-12 is allowable if \>= 6 months have elapsed since the end of IL-2 treatment or if \>= 12 months have elapsed since rhIL-12 therapy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Interleukin-12 Subunit p35; Interleukin-12; aldesleukin; Interleukin-2

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Lymphokines

Study Officials

• Michael Atkins

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: July 24, 2003
• Study Start: March 1, 2000
• Primary Completion: July 1, 2003
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

US (1)