Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Interleukin-7 in Treating Patients With Refractory Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI NCI-03-C-0152I NCT00062049

Special Category: NCI Web site featured trial

Objectives

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

Entry 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

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

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/mm³
• Platelet count greater than 100,000/mm³
• 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
• FEV₁ greater than 50% of predicted

Immunologic

• No autoimmune disease
• Peripheral CD3+ cell count greater than 300/mm³ 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Claude Sportes, MD, Protocol chair		Ph: 301-435-5280 Email: csportes@mail.nih.gov
Ronald Gress, MD, Protocol co-chair		Ph: 301-435-4654 Email: gressr@exchange.nih.gov

Related Information

Web site for additional information
Featured trial article

Registry Information
Official Title		A Phase I Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Patients with Refractory Non Hematologic Malignancy
Trial Start Date		2003-04-22
Registered in ClinicalTrials.gov		NCT00062049
Date Submitted to PDQ		2003-04-22
Information Last Verified		2007-02-07