Clinical trial · Interventional
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
NCT00062049CI-TRIAL-00006408completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interleukin-7 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTSportes 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