Interleukin-7 in Treating Patients With Refractory Solid Tumors

March 7, 2012 updated by: National Institutes of Health Clinical Center (CC)

A Phase I Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Patients With Refractory Non Hematologic Malignancy

RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with refractory solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the safety and dose-limiting toxicity of biologically active doses of interleukin-7 in patients with refractory solid tumors.
  • Determine a range of biologically active doses of this drug in these patients.
  • Determine the biological effects of this drug in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
  • Determine the antitumor effects of this drug in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive interleukin-7 (IL-7) subcutaneously on days 0, 2, 4, 6, 8, 10, 12, and 14 (for a total of 8 doses) in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose (MTD) and "biologically active dose" (BAD) are determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The BAD is defined as the dose that produces a sustained 50% increase in CD3+ count over the patient's baseline without unacceptable toxicity.

Patients are followed at 1, 3, and 6 months and at 1 year after study completion.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3.75-10 months.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
      • Bethesda, Maryland, United States, 20892
        • NCI - Center for Cancer Research
    • Texas
      • Houston, Texas, United States, 77030
        • Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy meeting both of the following criteria:

    • No known curative therapy
    • Failed standard therapy, defined as either lack of response OR disease progression (i.e., at least 25% increase in disease or new disease)
  • Measurable or evaluable disease
  • No hematopoietic malignancies
  • No primary carcinoma of the lung

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • No proliferative hematologic disease

Hepatic

  • AST and ALT less than 3 times upper limit of normal (ULN)
  • PT/PTT no greater than 1.5 times ULN
  • No documented hepatitis B infection
  • No documented hepatitis C infection

Renal

  • Creatinine clearance greater than 60 mL/min

Cardiovascular

  • Ejection fraction greater than 45% by MUGA
  • Hypertension (resting blood pressure greater than 140/90 mm Hg) must be controlled with standard anti-hypertensive therapy

Pulmonary

  • No severe asthma
  • DLCO/VA greater than 50% of predicted
  • FEV_1 greater than 50% of predicted

Immunologic

  • No autoimmune disease
  • Peripheral CD3+ cell count greater than 300/mm^3 and stable on 4 successive determinations
  • HIV negative

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other medical or psychiatric condition that would preclude study compliance
  • No cognitive impairment or likelihood of developing cognitive impairment during study participation
  • No need for palliative therapy
  • No splenomegaly

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy by cytokines, anti-tumor vaccines, or monoclonal antibody therapy prior to the initiation of peripheral CD3 count determination
  • No prior allogeneic hematopoietic stem cell transplantation
  • No other concurrent immunotherapy
  • No other concurrent biologic agents (e.g., growth factors or monoclonal antibodies)

Chemotherapy

  • No concurrent chemotherapy

Endocrine therapy

  • No prior systemic corticosteroid therapy for more than 72 hours within the 2 weeks prior to initiation of peripheral CD3 cell count determination
  • No concurrent chronic steroid therapy

Radiotherapy

  • Not specified

Surgery

  • No prior solid organ transplantation
  • No prior splenectomy

Other

  • More than 4 weeks since prior cytotoxic therapy prior to the initiation of peripheral CD3 cell count determination
  • No concurrent cytotoxic therapy
  • No concurrent immunosuppressive therapy
  • No concurrent medications for the treatment of hypertension
  • No concurrent chronic asthma medications

  • No concurrent chronic anticoagulants (e.g., high-dose warfarin, heparin, or aspirin)

    • Low-dose oral warfarin allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Claude Sportes, MD, National Cancer Institute (NCI)
  • Ronald E. Gress, MD, NCI - Experimental Transplantation and Immunology Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 5, 2003

First Submitted That Met QC Criteria

June 5, 2003

First Posted (Estimate)

June 6, 2003

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 030152
  • 03-C-0152I
  • CDR0000304451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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