Interleukin-7 in Treating Patients With Refractory Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00062049
First received: June 5, 2003
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: recombinant interleukin-7
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Patients With Refractory Non Hematologic Malignancy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 30
Study Start Date: April 2003
Study Completion Date: May 2011
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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062049

Locations
United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
United States, Texas
Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Study Chair: Claude Sportes, MD National Cancer Institute (NCI)
Investigator: Ronald E. Gress, MD NCI - Experimental Transplantation and Immunology Branch
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00062049     History of Changes
Obsolete Identifiers: NCT00059059
Other Study ID Numbers: 030152, 03-C-0152I, CDR0000304451
Study First Received: June 5, 2003
Last Updated: March 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014