- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00121290
SJG-136 in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery
A Phase I Dose Escalation Study of Daily x 3 Intravenous SJG-136 in Patients With Advanced Solid Tumors
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of SJG-136 in patients with metastatic or unresectable solid tumors.
II. Determine the safety and dose-limiting toxic effects of this drug in these patients.
III. Determine, preliminarily, the efficacy of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetic parameters of this drug and its metabolites in these patients.
II. Correlate pharmacokinetic parameters with clinical effects of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive SJG-136 intravenously (IV) over 20 minutes once daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of SJG-136 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. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed up for 30 days.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Tennessee
-
Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt-Ingram Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients must have histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- Prior chemotherapy or immunotherapy allowed
- Time interval must be at least 4 weeks since prior chemotherapy or immunotherapy, 6 weeks if the last regimen included BCNU or mitomycin C
- Radiation therapy to < 25% of hematopoietic bone marrow is allowed
- ECOG performance status =<2 (Karnofsky >= 60%)
- Life expectancy of greater than three months
- Recovered from prior therapy
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- Ability to understand and the willingness to sign a written informed consent document
- WBC >= 3,000/mm^3
- Absolute neutrophil count >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal
- Creatinine =< 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- No unstable angina pectoris
Exclusion Criteria:
- Patients receiving any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SJG-136, breastfeeding should be discontinued if the mother is treated with SJG-136
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SJG-136
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with SJG-136
- With the exception of alopecia (and other situations in which the organ dysfunction or symptoms are considered clinically insignificant or irrelevant to this study), patients may not have baseline organ dysfunction or symptoms that qualify as Grade 2 or greater by CTC AE v. 3.0
- No other chemotherapy, immunotherapy, radiation therapy, surgery for cancer (including resection of any metastases), specific antitumor therapy, or experimental medications will be permitted while the patients are participating in this study
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Palliative radiation therapy is not allowed
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Treatment (SJG-136)
Patients receive SJG-136 IV over 20 minutes once daily on days 1-3.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Studi correlati
Studi correlati
Altri nomi:
Dato IV
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
MTD defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Lasso di tempo: 21 days
|
21 days
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Bivariate response variable (tumor response) evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Lasso di tempo: Up to 5 years
|
Up to 5 years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Igor Puzanov, Vanderbilt-Ingram Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NCI-2009-00085 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- P30CA068485 (Sovvenzione/contratto NIH degli Stati Uniti)
- U01CA099177 (Sovvenzione/contratto NIH degli Stati Uniti)
- CDR0000653877
- PHI 0453 (Altro identificatore: Vanderbilt-Ingram Cancer Center)
- 6816 (Altro identificatore: CTEP)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su analisi di laboratorio dei biomarcatori
-
ORIOL BESTARDCompletatoTrapianto di rene | Infezione da CMVSpagna, Belgio
-
Progenity, Inc.CompletatoSindrome di Down | Aneuploidia | Sindrome di DiGeorge | Sindrome di Turner | Sindrome di Klinefelter | Delezione cromosomica | Sindrome di Edwards | Sindrome di PatauStati Uniti
-
Vanderbilt University Medical Center4DMedicalCompletato
-
RWTH Aachen UniversitySconosciutoEmorragia subaracnoidea aneurismaticaGermania
-
Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)Non ancora reclutamentoInfezioni da HIV | Epatite B
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalReclutamento
-
University of MiamiAttivo, non reclutante
-
Universidad Miguel Hernandez de ElcheInstitut Català de la Salut; Andaluz Health Service; Osakidetza; Servicio Madrileño... e altri collaboratoriCompletatoMalattie professionaliSpagna
-
Rio de Janeiro State UniversityCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... e altri collaboratoriCompletatoMalattia cardiovascolare | Carenza di vitamina D | Condizioni correlate alla menopausaBrasile
-
RenJi HospitalSconosciutoCarcinoma a cellule squamose dell'esofagoCina