- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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New York
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Buffalo, New York, États-Unis, 14263-0001
- Roswell Park Cancer Institute
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Ohio
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Columbus, Ohio, États-Unis, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Zale P. Bernstein, MD, Roswell Park Cancer Institute
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RP 99-11
- RPCI-RP-9911
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