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Interleukin-7 in Treating Patients With Refractory Solid Tumors

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00062049
Enrollment
30
Registered
2003-06-06
Start date
2003-04-30
Completion date
2011-05-31
Last updated
2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief summary

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.

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.

Interventions

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026