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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014