Interleukin-7 in Treating Patients With Refractory Solid Tumors

NCT00062049 | Completed Phase 1

• 3 other identifiers: 03015203-C-0152ICDR0000304451
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

recombinant interleukin-7 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Sportes C, Babb RR, Krumlauf MC, Hakim FT, Steinberg SM, Chow CK, Brown MR, Fleisher TA, Noel P, Maric I, Stetler-Stevenson M, Engel J, Buffet R, Morre M, Amato RJ, Pecora A, Mackall CL, Gress RE. Phase I study of recombinant human interleukin-7 administration in subjects with refractory malignancy. Clin Cancer Res. 2010 Jan 15;16(2):727-35. doi: 10.1158/1078-0432.CCR-09-1303. Epub 2010 Jan 12.

  PMID: 20068111 RESULT

MeSH Terms

Interventions

Interleukin-7

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Claude Sportes, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

• Ronald E. Gress, MD

  NCI - Experimental Transplantation and Immunology Branch

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: April 1, 2003
• Study Completion: May 1, 2011
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

US (3)