- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00058045
Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
A Phase I Study Of Low-Dose Subcutaneous Interleukin 2 (IL-2) And Stem Cell Factor (r-metHuSCF) For Patients With AIDS And AIDS-Associated Malignancy
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of cancer therapy.
PURPOSE: Phase I trial to study the effectiveness of combining interleukin-2 with stem cell factor in treating patients who have AIDS or AIDS-related cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the safety and toxicity of low-dose interleukin-2 and stem cell factor in patients with AIDS or AIDS-related malignancies.
- Determine the immune status of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of stem cell factor.
Patients receive interleukin-2 (IL-2) subcutaneously (SC) six days a week and stem cell factor SC three times a week for 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of stem cell factor until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 3 patients receives treatment at the MTD.
Patients are followed every 2 weeks for 1 month.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43210
- Arthur G. James Cancer Hospital - Ohio State University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Diagnosis of HIV-1 by ELISA, Western blot, polymerase chain reaction, or other documentation
Must have had 1 of the following AIDS-defining illnesses:
- Opportunistic infection
- Opportunistic malignancy (excluding CNS involvement)
- CD4 T-cell count less than 200/mm^3 (but currently greater than 20/mm^3)
- Receiving antiretroviral therapy
No concurrent Kaposi's sarcoma
- Prior Kaposi's sarcoma in complete response allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 80-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count greater than 1,000/mm^3*
- Hemoglobin at least 10 g/dL*
- Platelet count greater than 50,000/mm^3* NOTE: *Transfusions and growth factors allowed in order to increase or maintain counts
Hepatic
- No major hepatic dysfunction evidenced by encephalopathy, ascites, or varices
- Bilirubin no greater than 2 mg/dL
- INR no greater than 1.5
Renal
- Not specified
Cardiovascular
- No prior angioedema
- No uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mmHg)
- No unstable angina
- No New York Heart Association class III or IV heart disease
- No congestive heart failure
- No coronary angioplasty within the past 6 months
- No myocardial infarction within the past 6 months
- No uncontrolled atrial or ventricular cardiac arrhythmia
Pulmonary
- No history of seasonal or recurrent asthma within the past 10 years
- No concurrent asthmatic symptoms (e.g., wheezing) related to a current respiratory tract infection
Immunologic
- No prior positive allergy test (skin or radioallergosorbent test) for insect venoms
- No known allergy to E. coli-derived products
- No prior anaphylactic events manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm
- Drug allergies manifested solely by rash and/or urticaria allowed
- No recurrent urticaria (isolated episode of urticaria allowed)
- No other active uncontrolled infection (including one with current symptoms of bronchoconstriction)
No fever of 38.2° C or higher
- Fevers due to B symptoms allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior or concurrent CNS malignancy
- No poorly controlled diabetes
- No other significant nonmalignant disease
- No other malignancy except those in stable partial response or stable complete response (no evidence of progressive disease for at least 8 weeks after therapy for the malignancy)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Hematopoietic in Patient Characteristics
- No prior stem cell factor
- No concurrent interleukin-11 for thrombocytopenia
Chemotherapy
- No concurrent chemotherapy for malignancy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent enrollment on any other protocol utilizing an investigational drug
- No concurrent beta adrenergic blocking agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Zale P. Bernstein, MD, Roswell Park Cancer Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RP 99-11
- RPCI-RP-9911
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre aldesleukina
-
Onur Boyman, MDTerminadoLupus Eritematoso SistémicoSuiza
-
National Institute of Allergy and Infectious Diseases...TerminadoInfecciones por VIHEstados Unidos
-
National Institute of Allergy and Infectious Diseases...Terminado
-
The Methodist Hospital Research InstituteTerminado
-
National Institute of Allergy and Infectious Diseases...Terminado
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...TerminadoInfecciones por VIHEstados Unidos
-
National Institute of Allergy and Infectious Diseases...TerminadoInfecciones por VIHEstados Unidos
-
Chiron CorporationTerminadoInfecciones por VIH | Retinitis por citomegalovirusEstados Unidos
-
National Institute of Allergy and Infectious Diseases...Terminado