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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Claude Sportes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Food and Drug Administration

Study ID:

030152

NCT ID:

NCT00062049

Start Date:

April 2003

Completion Date:

May 2011

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Methodist HospitalHouston, Texas  77030
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182
NCI - Center for Cancer ResearchBethesda, Maryland  20892